gmp7

Course Details

Scope: Cannabis

Session Length: Half day

Location: On-site at client

Pricing: Contact Sales

Cannabis Good Production Practices

Half-day interactive training program

Course Overview

Licensed Producers are required to meet the requirements of the Access to Cannabis for Medical Purposes Regulations (ACMPR). This course helps Licensed Producers understand their requirements under the ACMPR. It is the responsibility of the Licensed Producer to understand the ACMPR and to be knowledgeable about their obligations.

“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.

Licensed Producers must also consult the relevant sections of the Food and Drugs Act (FDA) and Narcotic Control Regulations (NCR) that apply to cannabis.

Course Objectives

  • Acquire basic knowledge of the Regulations for Cannabis for Medical Purposes (ACMPR) and Good Production Practices (GPP)
  • Recognize the importance of the ACMPR and GPP
  • Assess and make decisions based on the ACMPR and GPP
  • Follow practices of job requirements in accordance with regulations
  • Recognize deviations from ACMPR and GPP

Who Should Attend?

Licensed Medical Cannabis Producers

Cannabis Producer:

Health Canada’s medical cannabis regulations have been evolving over the past ten years. Producers have been challenged in understanding and meeting Health Canada’s changing expectations. Q&C has been helping one of Canada’s largest producers of medical cannabis to ensure their operations follow best practices to ensure the highest quality strains. We prepared their original QAR and supporting procedures in accordance with the earlier MMPR regulations, and then updated them to align with the latest ACMPR requirements. We have now implemented full Good Production Practices, including HVAC validation, irrigation systems validation, facility design qualification and inventory management system validation. Throughout this evolving process, they have met all Health Canada expectations with minimal requests for clarification.

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
Price
Contact Sales

gmp5

Course Details

Scope: Drugs, NHPs or Cannabis

Session Length: 2 hours

Location: On-site at client

Pricing: Contact Sales

Good Manufacturing Practices Overview for Management

2-hour GMP management overview

Course Overview

A compact 2-hour learning program where managers train managers on Health Canada's Good Manufacturing Practices (GMPs)

This course:

  • Provides a compact learning package that enables you to gain a working knowledge of GMP
  • Shows you how to apply GMP principles
  • Simplifies the regulations and helps you understand why you need to comply and what you need to do to comply
  • Identifies regulatory expectations
  • Shows you how to implement GMP to avoid surprises in government audits
  • Greatly reduces the risk of failing an audit
  • Employs interactive Mr. GMP Exercise™
  • Answers your questions based on the most current interpretations of the GMP regulations
  • Gives you a participant binder, course certificate, and indexed GMP pocket booklet. The Blue Book™ will be an indispensable reference for your day-to-day activities in the workplace

Course Objectives

  • Acquire and apply the basic concepts of GMP
  • Recognize the importance of GMP compliance
  • Understand the role of Quality Control

Who Should Attend?

  • Executives in the pharmaceutical and biotechnology industries
  • Non-technical audience
  • Managers with no formal training in GMP

Expedited Drug Establishment Licence (DEL) Approval

An importer client did not allow for the 250-day lead time required by Health Canada to add their new product’s manufacturing site to their Health Canada Drug Establishment Licence. Q&C convinced Health Canada that the new product was medically necessary for multiple sclerosis. We submitted medically necessary documentation and gathered the GMP evidence to support the manufacturing site amendment. This expedited Health Canada’s review, which allowed the product to be launched on schedule.

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
Price
Contact Sales

gmp6

Course Details

Scope: Drugs and/or NHPs

Session Length: Half day

Location: On-site at client

Pricing: Contact Sales

GMP Fundamentals for Fabricators

1-day interactive training program

Course Overview

This full-day program shows new and experienced employees the Good Manufacturing Practices (GMP) standards and how they can help ensure your organization complies with them. The program:

  • Provides a compact learning package that enables you to gain a working knowledge of GMP in one day
  • Shows you how to apply GMP principles
  • Provides a methodical approach to GMP that simplifies the regulations and helps you understand why you need to comply and what you need to do to comply
  • Identifies regulatory expectations
  • Shows you how to implement GMP to avoid surprises in government audits
  • Greatly reduces the risk of failing an audit or self-inspection
  • Helps you prepare a plan for implementing GMP immediately on your return to the workplace
  • Provides documented effectiveness of learning (completed quiz)
  • Gives you plenty of practice so you’ll leave with proven skills
  • Employs interactive exercises, industry-based case studies, hands-on tasks designed to involve and engage the participant
  • Emphasizes adult learning principles
  • Answers your questions based on the most current interpretations of the GMP regulations
  • Gives you a participant binder, marked quiz, course certificate, and an indexed GMP pocket booklet. The Blue Book™ will be an indispensable reference for your day-to-day activities in the workplace

Course Objectives

  • Acquire and apply the basic concepts of GMP
  • Recognize the importance of GMP compliance
  • Understand the role of Quality Control
  • Apply the GMP regulations to the Manufacturing and Distribution Cycles
  • Courses are available for Drugs, NHPs and Dietary Supplements

Who Should Attend?

  • Fabricators, packagers/labelers, testers in the pharmaceutical and biotechnology industry
  • New employees, and those who have production experience with no formal training in GMP
  • Personnel with training who need to stay current with GMP
  • 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
    Price
    Contact Sales

    gmp5

    Course Details

    Scope: Drugs and/or NHPs

    Session Length: Half day

    Location: On-site at client

    Pricing: Contact Sales

    GMP Fundamentals for Importers & Distributors

    Half-day interactive training program

    Course Overview

    This half-day course presents participants with the essential Health Canada Good Manufacturing Practices (GMPs) requirements for pharmaceutical Importers and Distributors, and is applicable for the following product categories:

    • Pharmaceuticals
    • Radiopharmaceuticals
    • Biologics
    • Veterinary

    All companies with a Drug Establishment Licence in Canada must follow the GMP 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, routinely delivered on-site to Importers and Distributors, provides you 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.

    Course Objectives

    • 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
    • Learn how to apply GMP principles to protect patients, and assure the quality of pharmaceutical products
    • Learn how to apply GMP principles to protect patients, and assure the quality of pharmaceutical products
    • Get a participant folder, marked quiz, course certificate, and an indexed cGMP/GMP pocket booklet. The Blue Book™ will be an indispensable reference for your day‐to‐day activities in the workplace.
    • Meet HPFBI training requirements (as per HPFBI GMP regulations C.02.006)
    • Learn how to implement GMP and avoid nasty surprises in government and supplier audits, or self‐inspections
    • Gain a working knowledge of GMP in a half‐day

    Who Should Attend

    • Canadian importers and distributors of pharmaceutical and biotechnological products
    • New employees and personnel with or without GMP training

    Q&C importing

    Q&C is the Health Canada licensed importer for many kinds of Health Canada regulated products, more than 200 products in all. We handle prescription and over-the-counter pharmaceuticals, radiopharmaceuticals, biological and veterinary drugs, including sterile drugs, controlled drugs and narcotics, natural health products and medical devices. Q&C performs over 1,100 product dispositions annually. In 2017, we hosted five separate Health Canada audits for importing activities. The Health Canada inspectors issued only minor observations, and in one audit there were zero observations noted. Two senior inspectors gave us positive feedback on the robustness of our importing quality systems.

    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
    Price
    Contact Sales