Working in a GMP Environment
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  • Day1: December 1, 2020
    9:00 am - 1:00 pm
  • Day2: December 2, 2020
    9:00 am - 1:00 pm
  • Day3: December 3, 2020
    9:00 am - 1:00 pm
  • Day4: December 4, 2020
    9:00 am - 1:00 pm
M QA QC RA

Certification Areas

Note: Health Canada released revised guidelines to the GMP Regulations GUI-0001 which became effective on July 1st, 2020. This course will include and cover these updates.

This interactive course provides a fresh dynamic every time you take it and offers alternative approaches to problem-solving. Hands-on exercises enable participants to map their individual GMP responsibilities and gain the skills and knowledge necessary to understand and work in a GMP compliant environment and contribute to the ongoing quality of their company. Group exercises and ample opportunity to share real-life experiences provide the participants with the added benefit of learning from their peers as well as the instructor.

 

Course Objective

This 4-day workshop (9 am – 1 pm each day) will cover the following topics:

  1. Introduction and summary of updates
  2. Premises,  Sanitation and Equipment-Personnel qualifications, training, and responsibilities
  3. The pharmaceutical quality system
  4. Testing, Raw materials, and Vendor Qualification
  5. Manufacturing Controls
  6. Outsourced Activities
  7. Quality Control Department
  8. Packaging and Finished Product Testing
  9. Retain Samples and Stability
  10. Documentation, record keeping, and Data Integrity
  11. Supporting quality systems elements (SOP’s, change control, deviations, non-conformance, product complaints and recalls, annual product review, self-inspection)
  12. Conclusions and wrap up

 

Who Should Attend

Personnel in the pharmaceutical and related industries with at least 1-year experience of working in a GMP environment or has experience with an equivalent quality system (e.g medical devices).

Personnel from quality assurance, production, laboratories, regulatory affairs, distributors and wholesalers, and auditors.

 

This course would be particularly suitable for those

  • —requiring a refresher course to ”get back to basics”
  • —interested in GMP updates and their implications
  • —wishing confirmation of their day to day GMP compliance activities.
  • —who participates/are responsible for training their own company employees in GMP related activities?
  • —are part of a smaller company that requires annual GMP training.
  • —who are involved in internal or external auditing?

 

Based on current versions of:

  • —Health Canada GUI-0001 Good Manufacturing Practices for Drug Products
  • —FDA part 211 Current Good Manufacturing Practice for Finished Products

 

Course Leader

Dr. Pauline McGregor, Ph.D. Chem, MRSC

Registration Deadline: 25 Nov 2020



Student Ticket: $250.00 On Sale
Basic Member: $600.00 On Sale
Pro Pro Plus Ticket: $550.00 On Sale