gmp1

Course Details

Scope: Drugs

Session Length: HALF DAY INTERACTIVE TRAINING PROGRAM

Open Session dates: TUESDAY MARCH 26, 2019; 9:00AM – 1:00PM

Pricing: $350 per participant

Fundamentals Of Good Manufacturing Practices

Active Pharmaceutical Ingredient and Product Importation

Health Canada GMP Regulations GUI‐0001, GUI-0104

Description

This half day course presents participants with the essential Health Canada Good Manufacturing Practices (GMPs) requirements for licensed pharmaceutical Importation and Distribution, and is applicable to Active Pharmaceutical Ingredients(APIs), and OverThe‐Counter/Category IV, Prescription and Biological products. All companies with a Drug Establishment Licence in Canada must follow these guidelines. Canadian GMPs are based on the Food and Drugs Act, and are the primary pharmaceutical industry guidance, designed to protect the patient or consumer, and assure the quality of pharmaceutical products.

This assessed and certified course is routinely delivered onsite to Importers and Distributors and is intended to provide participants with the knowledge to complete foundational and ongoing GMP training requirements.

This training also includes a GMP‐relevant understanding of current Health Canada hot topics, describes useful regulatory resources, and addresses proposed changes to the GMP guidance as outlined within the recent industry consultation.

WHO SHOULD ATTEND

  • Canadian Importers and Distributors of Over‐The‐Counter/Category IV, Prescription and Biological products
  • Canadian Importers and Distributors of Active Pharmaceutical Ingredients (APIs)
  • New employees with no formal training in GMP
  • Personnel with existing training who need to stay current with GMP

PURPOSE OF WORKSHOP

  • Gain a basic understanding of GMP regulations
  • Review a brief history of GMP; understand the role of quality control and quality assurance; learn about equipment use, validation, sanitation, labeling, records, records and good documentation; and look at deviations, change control and audits
  • Address requirements for Drug Establishment Licensing of APIs and Products
  • Shows you how to apply GMP principles to protect patients, and assure the quality of pharmaceutical products
  • Provides a methodical approach to GMP that simplifies the regulations and helps you understand how to comply
  • Gives you a participant folder, marked quiz, course certificate, indexed cGMP/GMP pocket booklet, and The Personal Action Plan™. The Blue Book™ will be an indispensable reference for your day-to-day activities in the workplace.
  • Course accommodates employees new to GMP, or experienced employees needing to stay current with GMP
  • On completion, learners meet HPFBI training requirements (as per HPFBI GMP regulations C.02.006)
  • Shows you how to implement GMP and avoid nasty surprises in government and supplier audits, or self‐inspections
  • Enables you to gain a working knowledge of GMP in a half‐day
Price
$350 per participant
Date
26-March-2019

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

Price
$950 per participant
Date

gmp2

Course Details

Scope: Drugs, NHPs or Cannabis

Session Length: Half day

Open Session dates: To Be Determined

Pricing: $350 per participant

Preparing for a Regulatory Inspection

Half-day interactive training program

Course Overview

As we are experienced auditors and we are often audited by government regulatory bodies, we are in a unique position to offer you a course that:

  • Shows you how to implement GMP to avoid surprises in government audits
  • Greatly reduces the risk of failing an audit or self-inspection
  • Provides documented effectiveness of learning (completed quiz)
  • Employs interactive exercises, industry-based case studies, hands-on tasks designed to involve and engage the participant
  • Emphasizes adult learning principles
  • Gives you a participant binder, marked quiz, and course certificate

Course Objectives

  • Describe the reasons for regulatory inspections
  • Explain the legal basis for inspections
  • Discuss the potential outcomes of an inspection
  • Distinguish between appropriate and inappropriate behaviors
  • Identify proper ways of responding to an auditor’s questions

Who Should Attend?

  • Fabricators/manufacturers, packagers/labelers, testers, importers, distributors, and wholesalers in the pharmaceutical and biotechnology industries
  • New employees and personnel with or without GMP training

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

$350 per participant

Price
$350 per participant
Date