Consulting / Large Compliance Project Management
Apotex Inc.
Developed and put in place record management system (including physical infrastructure) by which training records for 1,600 employees are organized and managed.
Established associated policies and procedures.
Developed and put in place procedures meeting GMP requirements for evaluation of training effectiveness.
Reviewed evidence to support vendor certification programs.
AstraZeneca
Developed system and implemented procedure for assessing accuracy of batch records.
DC Labs Limited
Identified gaps in quality system, developed full quality plan to implement GMPs; overseeing completion of 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.
Generex Biotechnology
Set up full quality systems to ensure GMP compliance for phase 2 oral-dose insulin products.
GlaxoSmithKline
Evaluated the accuracy and adequacy of master records on all pharmaceutical and consumer health products imported by client for sale in Canada. Designed and implemented new, more useful and productive database structure.
Lorus Therapeutics
Identified gaps in quality system, developed full quality plan to implement GMPs; overseeing completion of plan.
Providing ongoing QA services and performing GMP compliance activities for a biopharmaceutical company specializing in the research, development, and commercialization of pharmaceutical products and technologies for the management of cancer.
Nowpac
Implemented GMP quality system for secondary packager.
sanofi pasteur
Determined maximum holding times for various intermediates.
Implemented protocol for a Historical Data Analysis.
Expedited the investigation, documentation, and closure of Process Deviation Reports (PDRs).
Consolidated process validation and bacteriology/bioburden compliance information for verification reports.
Organized, reviewed and verified stability data for Research & Development department; prepared detailed stability reports.
 
Tropicana
Designed and implemented full Quality System in preparation for new product launch.
Virox Technologies Inc.
Identified corrective actions required by initial government findings of GMP compliance gaps.
Coached client staff representative on interpretation of FDA regulations, implementation of cGMP compliant systems, drafting of required documentation, and creation of required training materials.
Saw client through to full cGMP compliance.
Veterinary Purchasing
As quality control advisor for veterinary wholesaler:
- Performed GMP self-inspection to address government audit finding.
- Developed and implemented corrective actions.
- Wrote/revised SOPs.
- Performed GMP training, mentored client for performance of ongoing training.
Audits
Alcon
Performed full GMP audit of importation facility.
Apotex Inc.
Performed GMP audits of:
- packaging material suppliers
- raw material suppliers
- third-party laboratories
Managed and performed in-house self-inspection audits.
Helix BioPharma Corp.
Determined requirements to bring laboratory and quality assurance areas in compliance with GMPs, including validation.
Novex Pharma
Performed GMP self-inspection audits for sterile drug fabricator:
- quality control
- production (non-sterile and sterile)
- validation
- laboratories
- materials management and warehouse
- engineering facilities
- purchasing
- information services
- human resources.
Nutrimetics
Performed general GMP audit for direct-selling skincare and cosmetic importer.
Solvay Pharmaceuticals
Performed on-site inspection and prepared gap analysis report for quality assurance and warehousing/distribution activities as per GMP guidelines.
Tropicana
Conducted full audit of manufacturing plant and validation of equipment, process and analytical method.
VitaPharm Ltd.
Provided full GMP audit of manufacturing facility.
Technical Writing Services
Adams Manufacturing (Division of Cadbury Schweppes)
Wrote/revised over 70 production procedures (SOPs) and work instructions for manufacturer of medicated confectioneries. Guided client through review and approval process to meet tight timeline.
Apotex Inc.
Coordinated technical writing project producing Quality Assurance documents for Innovative Drug Development.
Eli Lilly Inc.
Produced Standard Operating Procedures (SOPs) for Quality Control Laboratories, Facilities Services, Product Services, Order Services, and Order Fulfillment.
Novartis
Produced 40 integrated SOPs for the manufacture, packaging and testing of liquid and tablet products.
Provided guidance on improvements necessary to bring processes up to U.S. cGMP standards.
sanofi pasteur
Wrote and updated numerous policies and procedures to new company standard for a wide range of departments (QA, QC, production, maintenance, etc.) ensuring compliance with cGMPs.
Taro
Wrote detailed SOPs for manufacturing and packaging operations.
Torcan
Wrote technical documentation and SOPs for research laboratory.
cGMP Training
Alcon
Trained packaging workforce in The Fundamentals of the GMPs.
Apotex Inc.
Performed GMP training needs analysis for all levels of company. Based on this analysis, developed multilevel GMP course curriculum.
Wrote and piloted comprehensive, multilevel GMP courses for workforce of 1,600.
Baxter
Delivered Fundamentals of GMP training program to high-level technical audience.
Cansera
Developed and delivered on-site GMP training, with special attention to sterile materials issues.
Estée Lauder
Trained 65 participants in The Fundamentals of the GMPs.
Eli Lilly Ltd.
Produced and delivered on-the-job training programs for Quality Control Laboratories, Facilities Services, Product Services, Order Services, and Order Fulfillment.
Lorus Therapeutics
Prepared and delivered Fundamentals of GMP training program for workforce in a biopharmaceutical company specializing in the research, development, and commercialization of pharmaceutical products and technologies for the management of cancer.
sanofi pasteur
Developed on-the-job training lesson plans for 15 production processes.
Wrote SOPs and delivered on-site training through to implementation.
Taro
Customized and delivered interactive training on regulatory inspections to a workforce of 130. Developed and delivered four-module GMP training course for operators.
Twinlab - Utah Division
Developed a customized course in which the training manual, activities and testing were all based on NNFA Supplement GMP (DSHEA Act of Congress-1994) requirements along with company operations and standards.
Delivered training to an audience drawn from all levels of the company.
VitaHealth Products
Trained 900 workers in the fundamentals of GMP. Course included group exercises, case studies, and comprehension assessment, all tailored to relate to particulars of client's operations.
ISO Services
CME
Implemented ISO 13485 quality system for designer of non-invasive blood sugar monitoring device.
Perform regular internal audits of quality system.
Germiphene Corporation
Provided ISO 9000 documentation evaluation and consulting.
Mac-Weld
Implemented ISO 9001:1994 quality system
Upgraded quality system to ISO 9001:2000 requirements.
Novex Pharma
Performed ISO 9002 internal audit for fabricator of sterile drug products.
QMI
Delivered seminars on ISO 9000 Introduction, Internal Audit and Lead Audit in partnership with QMI - North America's largest ISO Registrar - to both QMI registrants and corporate group audiences.
The Arthur Press
Set up ISO 9000 Quality System and associated processes and manuals for packaging component supplier to pharmaceutical industry.
Assisted client to successful ISO 9002 registration.
Upgraded quality system to ISO 9000:2001 requirements.
Provide ongoing quality system support, including internal audits.
Validation
Biovail
Performed equipment grouping, worst-case determinations and calculation of validation acceptance criteria
Developed and wrote Cleaning Validation Master Plan and associated procedures
Lander
Developed and wrote Validation Master Plan, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for drug and cosmetics manufacturing company.
Wrote associated SOPs.
Performing all validation activities.
Nowpac
Developed and wrote master validation plan and associated protocols for validation of Filling & Packaging equipment.
Wrote associated SOPs.
Performed Installation Qualification (IQ) and Performance Qualification (PQ) on Filling & Packaging equipment.
Tropicana
Developed and write master validation plan and associated protocols for drug manufacturer.
Performed validation - (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) - of equipment, process, and analytical methods.
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