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.

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.

• Honours Bachelor of Science (Microbiology), University of Guelph

• 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