Quality & Compliance Services Inc.

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Allison Westlake - Consultant

Allison Westlake is an experienced quality assurance professional with more than 12 years in the pharmaceutical industry. She is a skilled auditor, technical writer, and certified trainer. Her project management skills have generated increased compliance and improved efficiencies in a number of Quality departments. With excellent communication skills, and her education, training, and work experience, Allison is a valued team member who can also work independently as needed to move a project forward. Previous employers include GlaxoSmithKline Canada Inc., Zeneca Bioproducts, Standard Biological Labs (SGS), Whitehall Laboratories, McCain Refrigerated Foods and Ault Foods.

Skills and Highlights

Quality Assurance

Produced Annual Product Reviews according to schedule for pharmaceutical products by compiling and reviewing data for complaints, deviations, changes, validation, packaging, stability and laboratory tests.
Performed statistical analysis using Statistica software program.
Identified trends and made recommendations on course of action.
Maintained databases for completed Product Reviews and outstanding notifications.
Revised Product Quality Review program to incorporate new initiatives and Global Corporate requirements.

Regulatory

Ensured regulatory compliance of processes with Good Manufacturing Practice and current Canadian, U.S., Rest of World and Global Corporate regulations.

Auditing

Conducted internal compliance audits in Quality Assurance and Manufacturing areas to ensure compliance with corporate quality standards.
Provided support during local and regulatory audits.

GMP Training

Performed employee training on standard operating procedures (SOPs).

Technical Writing

Created and revised SOPs, Training Modules and Performance Assessments.

Validation

Assisted microbiology lab in performing water system validation for new building.

Lab Services

Performed various microbiological tests on finished products, raw materials, media, the environment, water and compressed gases.
Documented results using LIMS and SAP.
Reviewed tests conducted by analysts and ensured specifications were met.
Conducted laboratory audits and prepared reports.
Certified Trainer.
Actively participated in investigations.
Trained and coached analysts on laboratory procedures.
Trended data and produced reports.
Won a Process Improvement Project of the Month award for the revision of the Compressed Dry Air monitoring program.
Worked as part of a cross-functional team to bring microbiology autoclave and other laboratory equipment into compliance with 21 CFR Part 11 and internal policies.
Coordinated and executed autoclave software upgrade and re-qualification.
Worked as part of team to redesign microbiology laboratory.

Education

Honours Bachelor of Science in Applied Microbiology, University of Guelph, Guelph, Ontario

Continuing Education, Career Development

Conducting Annual Product Reviews – PSG 2007
Auditing and Regulatory Inspections – GSK 2004
GMPs for Lab Personnel – GSK 2003
Computer Validation – PSG 2001
Microbiological Auditing – PSG 1999
Internal Computer Training in Statistics, SAP, Word, Excel and PowerPoint

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Carmen Fletcher – Q&C Consultant

Carmen is a dedicated, flexible professional with excellent organizational and problem-solving skills supported by 17 years of pharmaceutical experience. She has a strong working knowledge of GMPs, cGMPs, and related regulations. Carmen works successfully in a team-based environment; as well, she demonstrates the ability to work independently on large projects.

Skills and Highlights

Quality Control Officer (QCO)

Oversaw all aspects of the Quality Control function for a large Canadian pharmaceutical contract support company
Reviewed master production, packaging, deviation, raw material, and stability reports and finished product data; assessed whether product met regulatory requirements prior to release in Canada
Worked with clients to revise and complete documentation in order to facilitate speedy release of product
Prepared submissions to Health Canada for drugs, natural health products, medical devices, establishment licenses, and other associated annual correspondence.

Quality Assurance

Developed program to track Laboratory Out of Specification Investigation Reports; used tracked data to prepare monthly trend analysis reports, which were used during Health Canada and FDA inspections
Worked with Canadian and U.S. management staff to develop a transition plan for outsourcing Chemistry Lab Analysis to a company’s corporate head office
Coordinated and performed laboratory site certification studies of new products and methods for Canadian pharmaceutical manufacturer
Performed stability analyses to support ongoing shelf life studies.

Auditing

Hosted Health Canada inspections for numerous clients
Prepared responses to Health Canada audit comments.

GMP Training

Performed employee training on standard operating procedures (SOPs).

Technical Writing

Developed and updated policies, GMP SOPs, and ISO quality system procedures to meet FDA and HPFBI requirements.

Validation

Reviewed new product technical files to determine validation and transfer criteria need to meet current regulatory guidelines
Performed method validation, process validation, and transfers of new products.

ISO Compliance

Oversaw a self-inspection program to meet ISO 9002 requirements
Prepared and presented internal self-inspection audits to management staff and tracked closure of action items
Drafted company quality manual and trained staff in relevant procedures
Hosted registrar audits.

Education

Bachelor of Science – Applied Chemistry and Biology, Ryerson Polytechnical University, Toronto, Ontario

Continuing Education, Career Development

Advanced GMP Auditing
Audit Skills
Deviations and Change Control
GMP for Wholesalers, Q&C
GMP Training
Guidance Workshops for Product Licences and Site Licences (NHPD)
HPFBI Audit Management
Industrial Drug Legislation (Seneca College)
Introduction to NHPD (NHPD)
ISO 13485 Essentials Course
ISO 9001:2000 Management Overview (PIC)
ISO 9002:1994
OOS/Deviation Reporting (Globepharm)
Technical Writing Course, Q&C

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Charlette Tam - Consultant

Charlette is a highly motivated, punctual and hard-working individual with strong communication and interpersonal skills, and excellent time management and organizational skills. With her work experience in quality control, particularly related to product release and its associated activities, and quality assurance, she is a valuable addition to our team and an asset on any project.

Skills and Highlights

Quality Control Officer (QCO) Services

Performed product release activities
Reviewed finished product, raw material and stability specifications against compendial monographs
Reviewed master labels against Health Canada’s guidelines
Reviewed stability protocols against ICH and Health Canada’s guidelines
Reviewed certificate of manufacture and analysis against finished product specifications
Reviewed stability summaries against pre-established stability specifications and protocols
Initiated, executed, and monitored change controls
Investigated and communicated with clients regarding various deviations, including:

out-of-specification results
sample label deviations
document deviations including master production documents, batch production documents, certificate of manufacture and analysis

Quality Assurance/Quality Control

Participated in internal audits:

Reviewed and updated company policies and manuals
Interviewed employees in various departments
Participated in meetings regarding the progress of current audits and the follow-ups from past audits

As a member of a consumer complaints team:

Composed monthly complaints report and prioritized problems of statistical importance
Determined the source of the problems and established solutions accordingly

Performed physical and functional tests on all packaging components in compliance to GMP, SOP, and GLP
Documented coherent records in accordance to SOP and GMP
Worked with various analytical instruments
Maintained and updated computer system SAP on a regular basis

Education

Bachelor of Science Honours Biochemistry/ Biotechnology Specialization (Co-op), University of Waterloo
Pharmaceutical Regulatory Affairs and Quality Operations (Co-op), Seneca College

Continuing Education, Career Development

Pharmaceutical Regulatory Affairs and Quality Operations (Seneca College)
Product Disposition, Q&C
Technical Writing Course, Q&C

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Dawn Cotter – Consultant

Dawn Cotter brings to Quality & Compliance Services Inc. (Q&C)^® strong organizational skills and a proficiency in dealing with detail. Her ability to optimize systems has been a great asset to (Q&C)^®. In addition to Dawn's twelve years experience in the financial industry, she has completed the following Q&C courses: 'Introduction to GMP Training for Importers/Distributors' and the 'Q&C Technical Writing Course'. Ms. Cotter holds a Bachelor of Science degree from the University of Toronto.

Skills and Highlights

Quality Control Officer (QCO) Services

Provides ongoing QCO services for several manufacturers of GMP-compliant products.

Technical writing

Assisted in summarizing data to support stability studies of biologics for large pharmaceutical manufacturer.

Education

Bachelor of Science, University of Toronto

Continuing Education, Career Development

Audit Skills
Fundamentals of GMP, Q&C
GMP Training for Importers/Distributors, Q&C
Product Disposition, Q&C
Technical Writing Course, Q&C

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Deborah Campbell - Owner

Deborah Campbell, P. Eng., maintains a clear vision of the company she founded in 1994. Quality & Compliance Services Inc. (Q&C)^® provides quality service and excellent value for its clientele. Deborah has worked in the field of quality assurance for 26 years and has experience as an auditor, trainer, technical writer, and consultant.

Deborah has built the good name of Quality & Compliance Services Inc. by understanding and meeting a client’s need. Her strong technical competence is underscored by an ability to ensure the right person with the right experience and training is assigned to a given project. Deborah has worked closely with senior leaders of many of Canada’s largest manufacturing and distributors of pharmaceutical products.

Deborah has successfully managed numerous assignments – from the production and delivery of high profile industry-sponsored seminars and workshops to the development and implementation of cGMP/GMP compliant quality systems for major manufacturers. Specific systems were designed for packagers and importers of pharmaceutical products to the pharmaceutical industry.

She is an industry representative to HPFBI and was a member of the Queen’s University Advisory Council on Engineering.

Education

Honours Bachelor of Science (Chemical Engineering), Queen's University
Deborah has taken numerous pharmaceutical industry programs related to GMP, cGMP, quality systems, compliance audits, training, and ISO management.

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Deirdre Grixti – VP Technical Services

Deirdre Grixti is a congenial team leader with 15 years QC laboratory and QA experience. A creative problem solver, she is able to conceive, develop, and implement new strategies and processes that improve quality and efficiency. In addition, she is both a dynamic leader and a committed team builder, prioritizing effectively while respecting the priorities of others.

Ms. Grixti communicates easily and openly with people at all levels of the industry. Proficient in GMPs in Canada and the United States, she is also knowledgeable in analytical laboratory procedures involving wet chemistry analysis, and in chemical assays using instruments such as HPLC, GC, IR, UV, and Dissolution. Deirdre's excellent project management skills are complemented by her ability to work with the client in utilizing their systems and their personnel to complete the project.

Skills and Highlights

Large Compliance Project Consulting

Developed a plan for transitioning a Research & Development drug product development site to a GMP facility; served as Quality Assurance during transition.
Managed a large validation implementation within a tight time frame of three weeks to meet a regulatory deadline.
Identified gaps in various quality systems, developed full quality plan for each to implement GMPs; overseeing completion of each plan.
Performing full range of on-site quality control activities and regulatory activities for independently owned Private Label manufacturer of OTC, prescription, narcotics, and herbal products.
Providing ongoing QA services and performing GMP compliance activities for a biopharmaceutical company.
Organized, reviewed and verified stability data for Research & Development department; prepared detailed stability reports.
Evaluated and restructured master document filing systems for a multinational brand-name consumer products manufacturer. Created an index of the documents required for each product and performed a gap analysis.
Performed quality control/assurance gap analysis of process systems and documentation for a pharmaceutical company involved in clinical trials. Worked with client to develop and implement processes and documentation addressing identified gaps.
Established, implemented, and maintained the following systems for a pilot plant: SOPs, Deviations, Change Control, Returns, Recalls, Complaints, Self-Inspection, Preventive Maintenance, Calibration, and Validation.
Implemented protocol for a Historical Data Analysis producing 90 final reports.

Technical Writing

Coordinated the development, writing, review, and approval of Standard Operating Procedures (SOPs) for a pilot plant (Facilities, Manufacturing, Laboratory, Shipping and Receiving, and Quality Assurance), ensuring that all complied with GMP and cGMP requirements.
Wrote Site Reference Files for a major pharmaceutical manufacturer’s main packaging, warehousing, fabrication, and distribution facilities.
Coordinated the drafting and revision of 40 SOPs for a smaller, innovative pharmaceutical manufacturer in a time span of seven weeks. Ensured that these SOPs met end-user needs while complying with GMP and cGMP standards for Canada and the United States.

cGMP Auditing and Training

Coordinated successful completion of a series of eight international supplier audits to a client's corporate standards in a 3-week period.
Coordinated and executed self–inspection program for a major pharmaceutical company.
Performed GMP audit for an importer.
Delivered a major pharmaceutical company's GMP training course for six months.
Provided weekly coaching to plant staff in the implementation of their GMP Quality Systems, achieving an HPFBI compliant rating within 3 months.

Education

Honours Bachelor of Science, Chemistry, University of Western Ontario, London, Ontario, 1986
Post Graduate Courses: Protein Biosynthesis, Lipids, 1987

Continuing Education, Career Development

Advanced GMP Auditing
Advanced GMPs and Current Inspection Trends, PSG
Advanced Instructional Techniques, Langevin
Auditing Skills
cGMP Overview, Aventis Pasteur
Clinical Trial Overview/ Introduction to Clinical Quality Assurance
Delegation Workshop/Thinc Strategies (Thinc)
Deviations and Change Control, Q&C
Fundamentals of Regulatory Affairs, CanReg Inc.
GMP for Importers/Distributors, Q&C
GMP Interpretation and Application, Pharmanet
GMP Manufacture of Drugs Used in Clinical Trials
GMP Training, Aventis Pasteur
HPFBI Audit Management
Industrial Drug Legislation, Seneca College
ISO 9001:2000 Overview, Q&C
Legal Issues in the Pharmaceutical Industry, PSG
Mechanics of Preparing INDs and NDAs and FDA Regulations, Centre for Professional Advancement
Pharmaceutical Label Review, CanReg Inc.
Product Disposition, Q&C
Project Management, Kepner-Tregoe
SOP Writing
Technical Writing Course, Q&C

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Graham Mills – Owner

Graham brings 29 years experience in management consulting, sales, marketing and sales management to his position at Quality & Compliance Services Inc. (Q&C)^® Graham has worked in a wide variety of industries, including work for over 80 Fortune 500 companies as a global business consultant.

Graham has extensive hands-on work experience in adult education — working first as a Facilitator, then for several years as an Account Executive with Achieve Global (formerly Learning International/Xerox Learning Systems).

Graham held a senior sales management position in a division of Unilever in Toronto for 4 years, and was for many years General Manager of the medical division of Praxair Inc., with responsibility for the Western Region.

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Greg Burnett - Consultant

Greg Burnett is an enthusiastic, reliable, hard-working consultant with more than 10 years work experience in the pharmaceutical manufacturing environment, including hands-on validation activities. In addition, he has a solid education, with a science degree and certificates in Drug Legislation and Regulatory Affairs. In his previous positions, he was instrumental in decreasing production costs and turnaround time, while improving overall productivity. He has extensive experience working in a team-based environment; as well, he demonstrates the ability to work independently on large projects.

Skills and Highlights

Production

Executed and reviewed manufacturing orders, including completion of labour data and cycle time tracking, according to SOP and GMP guidelines
Operated and maintained Dispensing, Encapsulation and Compression equipment in the manufacture of solid dosage form products per established Technical Manuals and SOPs
Manufactured, formulated, packaged and labeled products under cGMP and SOP guidelines for medical disinfectant solutions manufacturer
Tracked stability data for manufactured product
Provided management with technical feedback on process and operational procedures to facilitate efficiency improvements to create 50% increase in overall productivity
Decreased production turnaround time and overhead costs by more than 30% and 10% respectively through identifying and correcting process inefficiencies, and troubleshooting and initiating mechanical changes to equipment
Reduced operating costs by more than 20% annually through preventive maintenance of equipment and facility
Ensured production deadlines were consistently met

Training

Trained new team members in formulation, blending and compressing of solid dose products through the use of Fluid Bed Granulation and various tablet presses
Trained new team members on the operation, dismantle, sanitation and assembly of equipment

Validation

Provided technical support to Validation and Product Development teams

Technical Writing

Contributed to upkeep and revision of Standard Operating Procedure Manuals
Co-authored ISO 9002 registration application

Education

Honours Bachelor of Science (Biology and Environmental Science), Trent University, Peterborough, Ontario

Continuing Education, Career Development

Industrial Drug Legislation, Seneca College
Introduction to Regulatory Affairs, Seneca College
GMP training

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Jennifer E. Grabel – Consultant

Hard working, team oriented and reliable, Jennifer Grabel uses her superior time and project management skills to successfully execute any project. She is a quick learner who has applied her knowledge in validation, technical writing and good manufacturing practices (GMP) to over twenty-five pharmaceutical facilities. With her experience in labs, production areas and office environments, this chemical engineer is a sure asset to your organization.

Skills and Highlights

Validation

Prepared Validation Master Plans (VMP) for pharmaceutical manufacturers and storage facilities.
Prepared qualification protocols (IQ, OQ, PQ), including manufacturing, warehouse, and packaging equipment, for pharmaceutical manufacturers.
Performed temperature mapping qualification of freezers and warehouse facilities.
Executed qualification protocols (IQ, OQ, PQ).
Prepared final reports for qualification protocols (IQ, OQ, PQ) summarizing results and conclusions.
Facilitated review and approval of VMP, unexecuted and executed protocols, and final reports.
Drafted critical utilities qualification, process validation and cleaning validation protocols.
Collected and analyzed data for statistical processing control unit.

GMP Consulting

Acted as Quality Operations GMP auditor and reviewed more than 1300 batch production records for a major pharmaceutical manufacturer.

Technical Writing

Drafted a series of Standard Operating Procedures (SOPs) and Quality Records to support the activities of a drug importer.
Drafted SOPs for equipment use and training.
Prepared Work Instructions for equipment use.
Created document tools to increase project efficiency and improve corporate uniformity for a large pharmaceutical company.

Education

Bachelor of Applied Science (BASc), Chemical Engineering and Applied Chemistry, University of Toronto, Toronto, Ontario

Continuing Education, Career Development

Cleaning Validation, PSG
Code of Business Conduct
Compliance Requirements for the Distribution and Transportation of Drug Product, PSG
Contamination Control and Clean Room Behaviour
Controlled Drug and Substances Handling, PSG
Global Records Retention Schedule Training Program
GMP Overview
Good Manufacturing Practices
Health, Safety, Environment Awareness Training
Industrial Drug Legislation, Seneca College
ISO 9001
Microsoft Visio, Excel and PowerPoint
Personal Protective Equipment, Spill Prevention and Control
Problems Encountered with Equipment Validation, ProGamma
Qualification and Validation of Pharmaceutical Processes and Equipment, Seneca College
Technical Writing Course, Q&C
Validation Overview
WHMIS certification Levels I and II

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Jennifer Gyorffy – Consultant

Jennifer is a committed, self-motivated and flexible individual with strong organizational and problem solving skills. With extensive experience in quality assurance and quality control for GMP and ISO systems, she provides valuable depth to the Q&C team. She manages her time effectively, and can work well as a team member or independently. Jennifer is able to establish and meet timelines for activities, managing and executing multiple tasks quickly and efficiently with minimal supervision.

Skills and Highlights

Quality Control Officer (QCO)

Performed product release and QCO services for GMP-compliant customers.
Assisted in release of finished products, drug products, clinical supplies, raw materials, and packaging materials.
Released components and finished products for medical device manufacturer.

Quality Assurance

Developed and maintained specifications (Packaging Materials, Raw Materials, Drug Product, Clinical, Bulk, In-process, Finished Product, Stability) and QA/QC test methods.
Reviewed manufacturing and packaging documentation.
Managed complaint investigation system.
Managed non-conformance and change control programs.
Prepared annual product reviews.
Investigated GMP deviations and implemented corrective and/or preventive actions.
Organized QA department for FDA inspection for Canadian medical device manufacturer.

Regulatory

Performed impact review of regulatory updates.

Auditing

Performed internal audits to ensure compliance with corporate quality standards.

GMP Training

Performed employee training on standard operating procedures (SOPs).

Technical Writing

Developed and updated policies, GMP SOPs, and ISO quality system procedures to meet FDA and HPFBI requirements.

Validation

Reviewed validation documentation.
Supported all aspects of in-house validation activity and at contractor sites for Canadian pharmaceutical manufacturer.

Production

Worked as an animal/research technician and process/product development technician for a Canadian medical device manufacturer.

Education

Honours Bachelor of Science, Biological Science, University of Guelph, Guelph, Ontario

Continuing Education, Career Development

Annual Product Review, PSG
Audit Skills
cGMP Annual Product Reviews
Change Control Management, IPA
Conducting GMP & Compliance Quality Audits
Controlled Drugs and Substances, PSG
Deviations and Change Control
Fundamentals of Regulatory Affairs, CanReg
GMP Fundamentals, PSG
GMP Overview
GMP Training Program, KMI/Parexel Inc.
GMP Training Update, CanReg
GMP/GLP Training
Introduction to Regulatory Affairs, PSG
Management & Leadership Skills for First-Time Supervisors & Managers
MS Access® Training
NHP Regulations, Q&C
Product Disposition, Q&C
System Validation and Introduction to 21 CFR Part 11, Invensys
Technical Writing Course, Q&C
The Compliance Conference, Insight Compliance Training Group
WHMIS certification
Women's Leadership Conference, Rockhurst University CEC, Inc.

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Kelly Brogan – Consultant

Kelly Brogan is a reliable, well-organized consultant/facilitator with more than 20 years experience in the pharmaceutical industry. Her responsibilities have included manufacturing, packaging, QC/QA, materials management, Standard Operating Procedure (SOP) writing and training, and GMP compliance.

Focused and thorough, Kelly advances task completion while ensuring that methodology is sound and results are accurate. Her wide-ranging pharmaceutical experience, her strong coaching skills, her friendly nature, and her scrupulous attention to detail make Ms. Brogan a valuable addition to any team.

Skills and Highlights

Technical Writing

Responsible for development and streamlining of over 150 SOPs for an innovative mid-sized pharmaceutical company, ensuring FDA and Health Canada (HPFBI) regulatory requirements were met. Other tasks included ensuring currency of existing SOP manuals and development of a database for safety, SOP, equipment, and process training materials.
Coordinated development and writing of SOPs for major pharmaceutical manufacturers, ensuring compliance with GMPs and cGMPs. Developed associated training.
Produced documentation and SOPs for a medical device importer and distributor, drug fabricator, packager, testing laboratory, importer, distributor, and wholesaler.

Quality Assurance/Quality Control Officer (QCO) Services

Completed deviation/investigation and change control reports for numerous large and small pharmaceutical companies; provided batch documentation review; wrote manufacturing and packaging directions ensuring adherence to GMPs, SOPs, and safety procedures.
Set up quality assurance systems for several importers/distributors.
Prepared and maintained Site Reference Files.
Coordinated product testing.
Handled correspondence and communication with Health Canada.
Hosted numerous successful HPFBI audits.

cGMP Training

Developed and delivered GMP Fundamentals, Deviation, Hygiene, and Sanitation OOS training programs to over 1,500 employees of large pharmaceutical manufacturer.
Delivered SOP, GMP, on-the-job, and safety training to employees at several major pharmaceutical manufacturers and several importers/distributors.
Developed Good Quality Practices training course for medical device company.
Developed and delivered a GMP training course for a major herbal company to NNFA specified standards.

cGMP Auditing

Provided auditing services for numerous large and small pharmaceutical companies and API suppliers; performed self-inspections, hosted successful Health Canada audits.
Participated in FDA audit of a large Canadian pharmaceutical fabricator.
Performed gap analyses of foreign fabricators to Canadian GMP standards.

Consulting

Experienced in a range of situations, including the following:
- Design of new manufacturing facility.
- Importation of pharmaceuticals from international suppliers.
- Coordination and supervision of third-party product suppliers.
- Leadership of process re-engineering team.

Education

Food and Drug Technology (3-year program), Durham College

Continuing Education

Advanced GMP Auditing
Audit Skills
Clinical Trial Overview/Introduction to Quality Assurance
Deviations and Change Control
Drug System Setup (Importer)
Fundamentals of Regulatory Affairs, CanReg
GMP for Importers/Distributors, Q&C
GMP for Wholesalers, Q&C
GMP Guidelines 2002 Edition workshop
HPFBI Audit Management
ICH Stability Guidelines
Industrial Drug Legislation, Seneca College
Introduction to Clinical Quality Assurance, PSG
Introduction to ISO 9001:2000, Q&C
Langevin Training Generalist Certificate
Level I Certificate of Achievement, PSG
Looking Through the Glass Into Our Changing Future, PSG
Pharmaceutical Label Review, CanReg
Product Disposition, Q&C
QMI Internal Auditor for Manufacturing
Review of Changes to Risk Classification for GMP Observations, Q&C
SOP Writing
Technical Writing Course, Q&C
Total Quality Advantage Facilitator Course, ODI, Boston
Training Needs Analysis Workshop

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Lynn Neely – VP Operations

Industrious and meticulous, Lynn Neely combines a solid background in science and pharmacy with exceptional communication skills to consistently produce work of the highest standard. Ms. Neely is flexible, outgoing and positive; she prioritizes and multitasks well; and she performs effectively whether working independently or as part of a team.

Skills and Highlights

Technical Writing

Wrote and revised set-up, operation and changeover SOPs for filling & packaging lines.
Completed writing and revision of over 70 production procedures and work instructions to meet tight timeline for drug manufacturer.
Managed SOP revision project for major pharmaceutical manufacturer.
Revised numerous SOPs (QA, QC, production) for a major pharmaceutical manufacturer ensuring compliance with GMPs and cGMPs.
Compiled a fully formatted, homogeneous document, based on submissions by a number of authors, for a large pharmaceutical company.
Produced a formatting template for a new drug submission for a large pharmaceutical company.
Produced an index to a body of government regulations for use by the pharmaceutical industry.
Revised policies and procedures for various pharmaceutical companies.
Helped reorganize and update policies and procedures for an institutional pharmacy, in support of successful application for government accreditation.
Wrote a User's Manual for a Personal Information Management application.

ISO Consulting

Led successful implementation of ISO 9001: 2000 quality system for a consultancy; registered with no audit findings.
Initiated system improvements and developed policies and procedures; hosted internal audits and official audits by external auditors.
Maintains ISO quality system for consultancy to ensure continued compliance; 3 year re-registration achieved with no findings.

Project Management

Managed a team that produced a user-friendly publication of a body of government regulations.
Managed several direct mail campaigns.

Administration

Reorganized a mid-sized volunteer organization, defining roles, responsibilities and procedures.
Restructured and streamlined a corporate invoicing process.
Implemented document control for a consulting company.

Education

Honours Bachelor of Science, Lakehead University
Pharmacy Assistant Diploma, Humber College
Technical Writing Certificate, Humber College

Continuing Education, Career Development

Business Writing & Grammar refresher course, SkillPath
cGMP Overview, Aventis Pasteur
Change Control, Aventis Pasteur
Clean Room Controls, Pharmaceutical Sciences Group
GMP Fundamentals Course, PSG
GMP Training, Aventis Pasteur
Instructional Design for New Designers, Langevin
Introduction to GMPs for Importers/Distributors (Quality Control Overview), Q&C
Introduction to ISO 9001:2000, Q&C
Organizing, Writing and Managing SOPs in compliance with GMP Requirements, PSG
Product Disposition, Q&C
SOP Writing
Technical Writing Course, Q&C
WHMIS certification Level II, Aventis Pasteur

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Maria De Sousa - Associate

Maria brings to Quality and Compliance Services Inc. (Q&C)^® strong communication and organization skills, an aptitude for transforming technical and jargon-laden information into clear and simple language, as well as the ability to improve efficiencies by implementing and automating processes.

Maria comes to us with over six years of experience as a Technical Writer. She has written manuals/online help, developed style standards and procedures, designed Web sites, published customer newsletters, written proposals, and provided software technical support. Maria also has experience in Administration and Marketing/Sales Support, where she has improved efficiencies and implemented cost-cutting measures. Maria has a diploma in Chemical Engineering Technology and experience in quality assurance and regulatory affairs.

CONTINUING EDUCATION, CAREER DEVELOPMENT

GMP for Importers/Distributors, Q&C
Technical Writing Course, Q&C

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Matthew Cousens – Consultant

With his project management skills and ability for prioritizing, Matthew is a valuable addition to the Q&C^®/ValidaPharm^™ teams and an asset on any project. He is a quick learner who can efficiently integrate his knowledge and experience in validation and GMP environments into project activities. Bright and very capable, he works well as a team member or independently, and is able to establish and meet timelines for activities.

Skills and Highlights

Validation

Performed qualification (IQ, OQ, PQ) of product equipment and plant utilities, including reactors, dryers, HVAC systems, clean rooms, and DI water systems, for Canadian pharmaceutical manufacturer.
Performed computer system validation on process control system.
Updated change control documentation to reflect new equipment and modifications to qualified equipment.
Managed qualification and validation activities, to ensure new equipment was commissioned on schedule, for large drug manufacturing company.
Assisted with the execution of cleaning validation protocols for equipment for a large pharmaceutical company.

Quality Assurance/Quality Control

Developed/revised SOPs and documentation for drug, natural health product, and medical device importers and distributors.
Applied GMP knowledge to develop SOPs for a pharmaceutical packager.
Managed environmental monitoring (EM) program for Canadian pharmaceutical manufacturer.
Trained employees in use of equipment and clean room behaviour.
Addressed deviations and resulting corrective actions.
Implemented innovative data analysis procedure to determine root cause of EM program failures, resulting in a 70% decrease in excursions.

Education

Bachelor of Applied Science, Engineering Science: Biomedical Engineering, University of Toronto, Toronto, Ontario

Continuing Education, Career Development

Aerial personnel lift operation
Cleaning Validation and Critical Cleaning Processes - Institute of Validation Technology
Computer Systems Validation
Confined Space Entry
Controlled Drug and Substance Handling, PSG
Fundamentals of Regulatory Affairs, CanReg
GAMP Good Practice Guide: Calibration Management
GMP for Importers/Distributors, Q&C
Good Automated Manufacturing Practices (GAMP 4)
Good Documentation Practices
Good Manufacturing Practices (finished products and active pharmaceutical ingredients)
Lock-out/tag-out procedures
SOP Writing
Technical Writing Course, Q&C
WHMIS certification

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Rachel Marcks – VP QA/QC

Rachel is a highly qualified Quality Assurance/Quality Control professional with over 15 years in the Canadian pharmaceutical industry plus prior international experience. With her extensive managerial expertise and knowledge of manufacturing compliance and quality control, she enhances our Q&C^® team capabilities. She works well without guidance, and also as part of a team. Rachel is a very capable, well-organized individual who is used to working through quality and procedural issues to find effective solutions that meet regulatory guidelines.

Skills and Highlights

Quality Assurance

Managed the quality department and GMP compliance for a Canadian facility for a multinational pharmaceutical manufacturer, resulting in successful regulatory inspections and customer audits, while allowing for continuous product introduction and company growth.
Performed review and final approval of new and revised company documentation (procedures, specifications, protocols, etc.) to ensure compliance with regulatory requirements and corporate policies.
Established and maintained a Change Control system that tracked and justified all changes to company documentation.
Managed release of batches to market following appropriate testing and review of batch documentation.
Participated in the introduction of 50 new products to a pharmaceutical facility over a 5-year period, while ensuring all appropriate validation, testing, and stability requirements were met prior to launch. Played a key role in managing corporate growth (e.g., in personnel and required documentation) at the same time.
Managed stability program for Canadian pharmaceutical company.

Auditing

Hosted and led preparation for bi-annual Health Canada and FDA audits, resulting in a HPFBI compliance rating and successful FDA pre-approval inspections.
Co-hosted and supported numerous audits for third-party manufacturers.

cGMP Training

Trained department personnel in QA procedures.

Education

B.Sc. (Chemistry Major), University of the Witwatersrand, South Africa

Continuing Education, Career Development

Advanced GMP Auditing
Auditing Skills
cGMP Annual Product Reviews
Deviations and Change Control
Fundamentals of Regulatory Affairs in Canada, Pharmahorizons
Fundamentals of Regulatory Affairs, CanReg
GMP for Importers/Distributors, Q&C
GMP Overview
HPFBI Audit Management
ICH Stability Guidelines
Industrial Drug Legislation (Seneca College)
Microbiological Control and Validation
Pharmaceutical GMP Audits and Inspections
Preparing for FDA Pre-approval Inspections
Product Liability Risk Management
Skin Delivery and Dermatologicals
SOP Writing
Technical Writing Course, Q&C

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Rashmi Sharma - Consultant

Rashmi Sharma is a congenial, hard-working, adaptable professional with excellent organizational and problem-solving skills and experience in regulatory affairs, quality assurance and pharmacovigilence. She has regulatory and scientific knowledge, strong analytical skills and excellent communication, presentation and team work abilities. She is able to manage multiple projects, prioritize and meet tight timelines.

Skills and Highlights

Regulatory

Prepared Notifiable Changes and Clinical Trial Applications
Assisted in preparation of Submissions including Supplemental New Drug Submissions and Establishment Licence/DIN Applications
Reviewed Product Labels and Advertisement dockets from Marketing
Prepared various post-marketing requirements (i.e., annual updates, monthly product commitments, yearly biologic product reports, licence amendments). Prepared and submitted design dossiers, screening deficiencies and Request for Additional Information from Health Canada for medical device applications (Class II-IV Applications, Amendment Applications)
Updated Product License Commitments (PLCs) for International countries
Completed product Renewal submissions
Responded to questions from Regulatory Authorities and Distributors
Completed Post Approval commitment submission to CBER

Quality Assurance

Ensured compliance with Canadian Medical Device regulations and interpretations
Worked on Change Assessments for Medical Device products
Managed tracking and reconciliation of physician samples for Sales Representatives
Compiled specific manufacturing and release data to support the preparation of reports such as annual product reviews, validation summaries, investigations and trend evaluations

Pharmacovigilence

Submitted Therapeutic Adverse Drug Reports and Medical Devices Problem Reports (Safety reports) to Health Canada

Technical Writing

Reviewed technical documentation for product release, development of procedures and maintenance files in compliance with Canadian GMPs
Assisted in the development of new SOPs and revision of existing SOPs to ensure continued GMP and corporate compliance

Education

Pharmaceutical Regulatory Affairs & Quality Operations (RAQC) Post-Diploma, Seneca College, Toronto, Ontario
Bachelor of Science, McMaster University, Hamilton, Ontario

Continuing Education, Career Development

GMP training certification (sanofi)
ISO certification training (sanofi)
eCTD training (sanofi)

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Richard Parcels – VP Regulatory & Compliance

A proven team leader and team player, Richard Parcels has a wide range of experience from scientific/technical analysis and validation to guiding merger talks between two laboratories. Mr. Parcels is versatile and thorough in working with the "big picture" to competently covering the smallest detail in GMP documentation. Well regarded in the industry, Richard builds on his expertise earned from Estee Lauder, Astra Pharma Inc., Warner-Lambert Parke-Davis and Health Canada.

Skills and Highlights

Quality Control/Quality Assurance

Oversaw detailed QA batch record review for release to market on sterile parenteral products.
Conducted biological indicator studies such as D-values and resistance verification according to USP XXIII.
Administered routine environmental monitoring in Classes 100, 1000 and 10, 000 using standard microbiological techniques and laser particle counters.
Completed routine water analysis and initiated investigation reports on products involved with the water samples when out-of-specification results were obtained.
Performed routine and investigational microbiological analysis of raw and ready-to-eat domestic and imported meat samples submitted by government meat inspectors.
Directed PCR analysis on samples for detection of Verocytotoxin-producing E. coli. Maintained cell lines for use in Vero Cell assays for detecting VTEC.
Carried out species verification of raw meat samples using agarose gel immunodiffusion (Ouchterlony Method). Performed antiseptic activities on products that claimed this property.
Determined microbial identifications using Vitek Jr. API 20E and API NFT.

NHPD

Prepared Site Licence Applications (SLAs) and Quality Assurance Reports (QARs) for new NPN products, and transitional products (DIN to NPN) for:
- Foreign manufacturer's site
- Canadian importation site
- Canadian manufacturer's site
Prepared Qualified QA Personnel Report Forms (for foreign sites).
Acting as Qualified QA Personnel for clients.

Technical Writing

Devised, wrote and updated standard operating procedures.
Wrote methods of analysis as well as method revisions and adaptation.
Developed and maintained a raw material supplier quality metrics database.

Validation

Performed validation studies for Getinge-Castle Autoclave, Bactometer, Laboratory Instruments, Microbiological Test Methods, Cleaning Validation, Process Validation and Water System Validation.
Routine and non-routine product testing and investigations.
Implemented a reduced powder product testing program based on formula type and validated manufacturing processes.
Performed USP XXIII Sterility testing, LAL and Liquid Particulate testing on finished product samples.
Validated the use of slit-to-agar samplers for the monitoring of filling zones of aseptic filling processes on Rommelag and Automatic Liquid Packaging machines.
Managed preparatory testing validation on finished products and raw materials.
Served on committee for the implementation of a system for the validation of test methods in a technical operations department.

GMP Consulting

Practical experience in a range of situations, including the following:

Development of cosmetic products at the lab batch and pilot batch level with respect to preservative systems and processing steps.
Implementation of a new procedure for the growth promotion testing of culture media.
Microbial testing on raw materials, finished products, stability samples, consumer complaints and in-process samples following USP microbiology methods and other validated methods.
Supervision of team of microbiologists, performing budgeting and annual performance reviews.

Education

Honours Bachelor of Science (Microbiology), University of Guelph

Continuing Education, Career Development

Advanced GMP Auditing
Audit Report Review
Auditing Skills
Auditing, PSG
cGMP Overview, Aventis Pasteur
Clinical Trial Overview/Introduction to Clinical Quality Assurance
Color & Make-Up, Society of Cosmetic Chemists
Delegation Workshop/Thinc Strategies, Thinc
Design of Experiments, G.R. Technologies
Deviations and Change Control
Drug DIN Applications
Fundamentals of Regulatory Affairs, CanReg
GMP for Wholesalers, Q&C
GMP Training, Aventis Pasteur
HPFBI Audit Management
ICH Stability Guidelines
Industrial Drug Legislation, Seneca College
Internal Auditor for Manufacturing, QMI
Introduction to Clinical Quality Assurance, PSG
Introduction to GMP Training for Importers/Distributors, Q&C
Introduction to Regulatory Affairs, PSG
NHP SLA Applications
NHPD workshop - Guidance workshops for Product Licences and Site Licences (Dec 2004)
NHPD workshop - Introduction to NHPD (Nov 2003)
Product Disposition, Q&C
Project Management, Kepner-Tregoe
Review of Changes to Risk Classifications of GMP Observations, Q&C
Supervisory Training
Technical Writing Course, Q&C
Validation and Qualification of Pharmaceutical Processes and Equipment, Seneca College (12-week course)
Validation for the 21st Century, PSG

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Sandra McDonald – Administrative Manager

Sandra comes to Quality & Compliance Services Inc. (Q&C)^® with administrative and accounting experience drawn from employment in the financial and medical service industries, and with management skills refined while running a successful business of her own for over 10 years. She is cheerful and indispensable, committed to doing her best and always helpful. Her background in client service and project management is fully utilized in her role as administrative support for our organization.

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Steve Hennigar - VP US Operations (Boston, MA)

Steve Hennigar, P.Eng., brings strong analytical and communications skills to Quality & Compliance Services Inc. (Q&C)^® Steve's presentation of his research thesis on the chemical modification of polymers was given a Neish award by Queen's University faculty and industry members. His positive outlook and proven problem-solving abilities allow Steve to complete projects and tasks efficiently without compromising quality.

Skills and Highlights

Validation

Drafted HVAC IQ/OQ/PQ protocols.
Performed Qualification (IQ/OQ) on Refrigerators, including temperature mapping of small size refrigerators and walk-in refrigerators using Kaye Validator®.
Drafted and executed equipment IQ/OQ protocols for drug manufacturer.
Drafted and executed analytical method validation protocols for drug product manufacturer.

Technical Writing

Drafted and revised cleaning procedures and work instructions to meet GMP standards.

Consulting

Revised more than 1,000 batch production records to assist with biologic manufacturer's backlog due to staffing transitions.
Developed medical devices according to FDA requirements in GMP environment.
Worked on project resulting in publication of "Determination of Alkoxyamine Concentrations in Nitroxyl Mediated Polymerization Products." Macromolecules, 35, 7628-7633 (2002).
Worked on project resulting in publication of "Silica Agglomeration and Elastomer Reinforcement: Influence of Surface Modification." Plastics, Rubber and Composites, 32, 1-8 (2003).

Education

Bachelor of Science, Chemical Engineering, Queen's University, Kingston, Ontario, 2002

Continuing Education, Career Development

Analytical Method Validation, PSG
cGMP Overview, Aventis Pasteur
Design and Validation of Critical Utility Systems, U of T
Fundamentals of Dissolution, PSG
Fundamentals of GMP for Packaging Suppliers, Q&C
GMP for Importers/Distributors, Q&C
GMP Overview
GMP Training, Aventis Pasteur
Industrial Drug Legislation, Seneca College
ISO Internal Auditor, Quality Management Institute (QMI)
ISO Overview, Q&C
Manufacturing Control in the Pharmaceutical Related Industries, U of T
Practical Method Development & Validation for HPLC (Waters)
Process & Cleaning Validation, U of T
Review of Analytical Data
SOP Writing
Technical Writing Course, Q&C
Validation Master Plan - Roadmap to Compliance, University of Toronto (U of T)
WHMIS certification

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Steven Danglay – Consultant

Steven Danglay is a well-rounded individual with experience in Quality Assurance (QA) and Quality Control (QC) in Canadian and U.S. pharmaceutical and biotech companies. His cheerful attitude, expertise, and attention to detail make him a valued project leader and/or team member. His experience, training, and knowledge make him a valuable addition to the Q&C team.

Skills and Highlights

Large Compliance Project Consulting

Planned/monitored release of biotechnology products
Audited QC testing and QA systems
Coordinated stability programs

Quality Assurance/Quality Control (QC)

Successfully implemented tools and standard operating procedures (SOPs) to institute metrics and deviations tracking for monitoring laboratory testing performance and promoting cycle-time reductions
Performed as lead auditor of QC laboratories and QA systems on cGMP compliance and testing performance, authored audit reports, hosted external vendor audits
Investigated root causes for cGMP deficiencies and testing delays to improve efficiency; created process maps to identify gaps and provide solutions (develop SOPs, evaluate systems), and neutralize gaps in documentation, sampling, and testing.
Monitored manufacturing, validation, and stability testing schedules; developed tools to collect metrics to audit test cycle times, batch release, and assay failures
Monitored sample distribution and testing by maintaining audit trail systems (e.g., LIMS, tracking calendars)
Prepared Certificates of Analysis for release of products.
Audited local site practices at biotech company and vaccine manufacturer
Authored policies and procedures to implement improvements and harmonization opportunities with global/corporate groups
Led a cross-functional task force team which developed an approach for addressing the stability of multi-component vaccine products and substances/ intermediates; remedied deficiencies, developed complex stability programs
Designed and coordinated stability surveillance studies for licensed vaccines with industrial operations (testing laboratories, regulatory affairs, manufacturing)
Ensured stability programs satisfied company quality and cost needs, cGMP, and regulatory requirements for licensure, post-licensure changes, and development
Provided training on new Quality Operations systems and procedural enhancements
Ensured departmental productivity by training staff on new improvements to continuously succeed in regulatory inspections
Developed electronic documentation portal on corporate Intranet for QA/QC documents (Certificates of Analysis, NWA Trending charts). Provided global, corporate-wide access to Release and QA documentation

Education

BSc Honours, Life Science (Microbiology, Immunology, Biochemistry, Molecular Biology), Queen’s University, Kingston, Ontario

Continuing Education, Career Development

Auditing Skills
Drug Product Stability and Shelf-Life, Center for Professional Advancement
GMP for Importers/Distributors, Q&C
GMP Overview
GMP Training, Biogen Idec
Graduate Certificate, Administration and Management, Harvard University Extension School, Cambridge, Massachusetts:

Communication in Business, Harvard
Information Technology, Harvard
Organizational Behavior, Harvard
Project Management, Harvard University Extension School, Cambridge, Massachusetts

Industrial Drug Legislation, Seneca College
Labware LIMS, Biogen Idec & Labware LIMS Solutions, Research Triangle Park, NC
LIMS Reporter (Infomaker) for Nautilus, Thermo Scientific, MA
Technical Writing Course, Q&C

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Verna Rathore - Consultant

Verna Rathore is a resourceful professional with top Quality Assurance training and over ten years experience in the pharmaceutical industry. Verna's dedication to detail, organizational, communication and problem solving skills were recognized in her previous management role as Quality Assurance Coordinator for Hemosol Inc. (Mississauga). In addition to quality assurance, Verna also brings considerable experience in the medical device industry and its related ISO elements. Her ability to persist in probing and evaluating information has enabled Verna to find smooth transitions in complex group and individual project work.

Skills and Highlights

Management of Change Control System

Reviewed, verified and approved Change Control documents.
Maintained Change Control records and database.
Wrote or revised SOPs, labels, product inserts and Change Control documents.
Coordinated and performed inspection, inventory control and release of finished product.
Management of Product Complaints - liaised with Clinical department in resolving complaints and coordinating corrective action.
Management of Incident Reports - reviewed accuracy and completeness of incident reports.
Provided training to new Quality Assurance staff.

Quality Assurance/Process & Product Development

Prepared report summaries of Quality Assurance systems for referencing and evaluation.
With Regulatory Affairs and Research Development designed a label for a new clinical product.
Performed ELISA, stability, and inspection testing of reagents for medical device establishment.
Introduced a more efficient ELISA procedure in order to reduce testing time by 50 per cent.
Extended shelf life and approval of 60 antibodies eliminating backlog of ELISA testing.
Assisted with internal audit for conformity to ISO 9001 element 4.15 Handling, storage, packaging preservation and delivery.
Redesigned, developed and resolved problems of oncology diagnostic kit.
Facilitated development of Design Control element ISO 9001 quality system for process qualification for medical device company.
Handled 4 individual and 3 group projects to redevelop/optimize, qualify and produce diagnostic products.
Successfully evaluated and transferred an immunoaffinity purification procedure reducing labor time and production costs.

Education

Bachelor of Science, Chemistry-Biochemistry Specialist, Mathematics Minor, University of Toronto
American Society for Quality Control (ASQC) Certificate, Quality Assurance

Continuing Education, Career Development

Annual Product Review, PSG
Good Manufacturing Practices
Industrial Drug Legislation, Seneca College
ISO 9001
Quality Auditing, Sheridan College
Radiation Protection
Technical Writing Course, Q&C
WHMIS certification