Working in a GMP Environment *January 2021*
Expired

  • Day1: January 12, 2021
    12:30 pm - 4:30 pm
  • Day2: January 13, 2021
    12:30 pm - 4:30 pm
  • Day3: January 14, 2021
    12:30 pm - 4:30 pm
  • Day4: January 15, 2021
    12:30 pm - 4:30 pm
M QA QC RA

Certification Areas

Course Description

This is our regular 2-day GMP course adapted for online presentation. 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.

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.

 

Course Objective

This 4-x half-day workshop  (12:30 pm – 4:30 pm each day) will cover the following topics:

 

Jan 12th – Session 1

• Introduction and overview of GMP

• Summary of Updates to GUI-0001 (July 1st, 2020)

• Exercise – Mapping personal GMP responsibilities

• Introducing the Quality Management System (QMS)

• Regulations

o Premises, sanitation, and equipment
o Personnel, training, qualifications and responsibilities

 

Jan 13th – Session 2

• Regulations

• Laboratory controls, Test Procedures and Specifications

• Raw Material Testing

• Manufacturing Controls, Packaging and Labeling Controls

• Quality Control Department

• Packaging Material Testing

• Retain Samples

• Stability

 

Jan 14th – Session 3

• Exercise – GMP regulatory observations

• Regulations

o Finished Product Testing

o Record Keeping

 

Jan 15th – Session 4

• Data integrity and documentation

• Supporting Quality Systems/Functions for GMP Compliance

o Outsourced activities

o Standard Operating Procedures (SOPs)

o Validation

o Change control

o Deviations/Non-Conformance

o Product Complaints and Recall

o Self-Inspection

o Annual product Review

• Overview/Summary

 

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, manufacturers, packagers, labellers, laboratories, regulatory affairs, importers, distributors, 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 participate/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: 8 Jan 2021



Basic Member: $725.00 Sold Out
Pro Pro Plus Ticket: $625.00 Sold Out