gmp3

Course Details

Scope: Drugs, NHPs or Cannabis

Session Length: Full Day

Open Session dates: To Be Determined

Pricing: $950 per participant

Conducting GMP Audits

1-day interactive training program

Course Overview

A full-day course to increase understanding of auditing techniques.

This program increases understanding of auditing techniques using adult learning principles.

Participants will:

  • Develop practical audit skills
  • Improve their evaluation and communication skills
  • Refine their reporting skills
  • Increase their ability to implement corrective action programs

The program:

  • Provides documented effectiveness of learning (completed quiz)
  • Employs interactive exercises, industry-based case studies, hands-on tasks designed to involve and engage the participant
  • Gives you a participant binder, marked quiz, and course certificate

Course Objectives

Upon completion of this program, participants will understand the audit process and will be able to:

  • Develop an audit checklist
  • Conduct internal and external audits
  • Document audit findings
  • Recommend fixes and corrective actions
  • Write an audit report
  • Evaluate audit responses

Who Should Attend?

  • Fabricators/manufacturers, packager/labellers, testers, importers, distributors, and wholesalers in the pharmaceutical and natural health and medical device industries
  • New employees and personnel with or without previous audit experience

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 an interactive training seminar

$950 per participant

$1,073.50HST
SKU
gmp3
Price
$950.00
Catalog
Course Fees
$950 per participant