Working in a GMP Environment
Upcoming

  • Day 1January 28, 2019
    9:00 am - 5:00 pm
  • Day 2January 29, 2019
    9:00 am - 5:00 pm

Location

15 Allstate Parkway, Suite 600, Markham, Ontario, Canada, L3R 5B4
M M QA QC

Certification Areas

Health Canada has recently released revised guidelines to the GMP Regulations which became effective in October 2018.  This course has been updated to include these changes.

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.

 

Course Objective

This 2-day course will cover the following topics:

 

  • Introduction and Definitions
  • Premises,  Sanitation and Equipment-Personnel qualifications, training and responsibilities
  • Developing a pharmaceutical quality system
  • Testing, Raw materials and Vendor Qualification
  • Manufacturing Controls
  • Outsourced Activities
  • Quality Control Department
  • Packaging and Finished Product Testing
  • Retain Samples and Stability
  • Documentation, record keeping and Data Integrity
  • Supporting quality systems elements (SOP’s, change control, deviations, non-conformance, product complaints and recalls, annual product review, self-inspection)

Who Should Attend

This is a good refresher course to ”get back to basics” for more seasoned personnel and for those wishing confirmation of their day to day GMP compliance activities. Those interested in the GMP updates and new employees to the pharmaceutical industry requiring GMP training would also benefit. Personnel from quality assurance, production, laboratories, regulatory affairs, distributors and wholesalers and auditors.

 

Course Leader

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



Student Ticket: $250.00 On Sale
Basic Member Ticket: $995.00 On Sale
Group Tickets (5+): $875.00 On Sale
Pro/Pro Plus Ticket: $925.00 On Sale