gmp1

Course Details

Scope: Drugs

Session Length: Half Day

Open Session dates: To Be Determined

Pricing: $350 per participant

The New 2018 GMPs

Half-day interactive training completely updated with new content

Course Overview

The new 2018 GMPs have wide-reaching changes and increased scope.

“Shoulds” have now become “musts”—where you once had the flexibility to negotiate in an audit it is now prescriptive, particularly with data integrity requirements.

Health Canada has adopted ICH Q7 and now expects involved oversight by Senior Management. Non-compliance of your Canadian operation can also now affect your global operations.

Guidances are more clearly inter-connected and are within scope of the Health Canada auditor. You must have a clear knowledge and understanding of all related policies, annexes and guidances to ensure your company’s continued compliance.

This course will:

  • Review the changes to the GMP
  • Clarify how the other guidances fit in
  • Examine the impact of the changes for your operations and supply chain
  • Review the specific data integrity expectations for systems of manufacturing, storage, distribution, quality control and laboratories
  • Clarify the new expectations for senior management
  • Explain the impact for your regulatory affairs, product registration and facility licensing
  • Outline the updated testing requirements for imported products
  • Fulfill the Health Canada requirement for initial and continuing GMP training

Course Objectives

  • Assess potential risks in your operations
  • Develop compliance action plans
  • Communicate the critical changes to senior management
  • Fulfill annual GMP training requirements

Who Should Attend

  • Regulatory Affairs
  • Quality Assurance and Quality Control
  • Laboratory personnel
  • IT/Computer personnel
  • Auditors

Health Canada Enforcement

In February, prior to Health Canada posting the new GMPs, Q&C hosted the Health Canada inspection of a large pharmaceutical wholesaler. The Health Canada inspector spent a considerable amount of the audit focusing on the lack of WMS validation and data integrity. This was surprising as it was the first time we had seen this expected for a Wholesaler. When the new GMPs were posted in the following weeks we saw that this was expressly addressed in Records. We are expecting strong audit focus on the all the new requirements, despite the new GMPs having an effective date of October 1, 2018.

Testimonial

I attended the Fundamentals of GMP on March 6, 2018 at Q&C in Mississauga. I thought the training was informative, compelling and complete and well worth the investment. I liked how Q&C had two different presenters, because we heard different perspectives on very important concepts. The instructors were very experienced and provided relevant examples that linked the content to actual client (no names) situations. The instructor leveraged multiple media formats, engaged the audience and addressed participant questions related to their organizations.

Why Train with Q&C?

  • Interactive sessions
  • Expert consultant trainers with hands-on industry experience
  • Course certificate to fulfill Health Canada’s annual GMP training requirement
  • We wrote the book on compliance…literally. Over 150,000 Blue Books have been published and used worldwide since 2002
  • Q&C has 25 years regulatory and compliance experience and we specialize in Health Canada remediations
  • We host at least one Health Canada audit each month and perform over 30 self-inspections annually

Sign up for our interactive training seminar

$350 per participant

$395.50HST
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gmp2
Price
$350.00
Catalog
Course Fees
$350 per participant