Working in a GMP Environment
Expired

  • March 7, 2017
    4:00 am - 11:30 am
  • March 8, 2017
    4:00 am - 11:30 am

Location

6257 Airport Rd, Mississauga, Ontario, Canada, L4V 1E4
QA

Certification Areas

Event Objective

Good Manufacturing Practices are critical to every day operations in the pharmaceutical industry. The basic principles of GMP are to assure the quality, potency, identity, safety and purity of products and to protect both the consumer and the company. This 2-day course provides a refresher of Good Manufacturing Practices based on current Health Canada and FDA guidelines. It includes the new requirements described in GUI-0001 version 2 which was released in 2011 by Health Canada as well as emphasizing the key changes brought about in the original version in 2009. It bridges the gap between the black and white regulations and everyday operations by describing the regulations and the practical application of them through key quality system elements, essential to GMP compliance. The course material is presented by means of slides, handouts and participation of the attendees through discussion and group exercises. 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.

Event Description

This 2-day course will cover the following topics:

    • Introduction and Definitions
    • Global GMP, including the new 2011 Health Canada GMPs
      Premises and Equipment
    • Personnel hygiene, training and responsibilities
    • Quality Assurance versus Quality Control
    • Manufacturing Controls
    • Packaging and Labelling
    • Documentation

 

  • 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. New employees to the pharmaceutical industry requiring GMP training would also benefit. Personnel from Quality Assurance, Production, Laboratory personnel, Regulatory Affairs, Distributors and Wholesalers and Auditors.

Speaker



Basic Member: $300.00 Sold Out
Basic Member Group Tickets: $200.00 Sold Out
Student Ticket: $250.00 Sold Out
Pro Ticket: $150.00 Sold Out

96%

Of attendees say their learning objectives were reached

90%

Of participants agree the intructor is effective

95%

Of viewers would recommend this course to others

Past Participants Say