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Course Details

Scope: Drugs, NHPs or Cannabis

Session Length: Half day

Open Session dates: September 11, 2018

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 September 11, 2018

$350 per participant

Price
$350 per participant
Date

gmp1

Course Details

Scope: Drugs

Session Length: Full Day

Open Session dates: September 12, 2018

Pricing: $950 per participant

Integrity 2.0: Managing Your GxP Data Program

Full-day interactive training

Course Overview

This course will reinforce your understanding of Data Integrity principles, and explain how to implement a compliant data quality program. The course addresses data used to make or support decisions that impact patient wellness and product quality and considers recent 2018 Health Canada guidance changes that mandate a data governance program.

This course will:

  • Review Data Integrity requirements embedded into the new 2018 GMPs
  • Clarify how other data guidances fit in
  • Review the specific data integrity expectations for systems of manufacturing, storage, distribution, quality control, and laboratories
  • Examine the impact of data integrity on your operations and supply chain
  • Explain the impact for your regulatory affairs, product registration, and facility licensing
  • Evaluate the impact of data integrity on key quality system metrics
  • Fulfill the Health Canada requirement for initial and continuing GMP training
  • Transform data integrity from laboratory-specific to company-wide governance
  • Evaluate the current industry trends toward cloud-based and AI (artificial intelligence) processes

Course Objectives

  • Explain what Data Integrity (DI) is
  • Communicate/explain DI expectations to other business partners
  • Identify areas of high risk to your patients and products
  • Assess potential risks in your supply chain and operations
  • Develop compliance action plans

Who Should Attend

Anyone who:

  • Currently works in a GxP environment that must meet regulatory requirements for computerized systems
  • Manages computerized systems (e.g., maintenance, system planned/unplanned changes)
  • Manages quality systems/practices using computerized systems (e.g., electronic disposition, change controls, etc.)
  • Conducts or audits self-inspection programs
  • Validates computerized systems for their intended GMP use and/or supports computer system validation activities either directly or indirectly
  • Designs or implements electronic systems intended for GMP use
  • Reviews and/or approves electronic records

Large Drug Wholesaler Questioned by Health Canada

In February 2018, prior to Health Canada posting the new 2018 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 warehouse management system 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 a strong audit focus on the all the new requirements, despite the new GMPs having an effective date of October 1, 2018.

Major Research and Testing Client Challenged by FDA

FDA challenged client on data integrity provisions and threatened an FDA 483. Q&C co-hosted the FDA audit with the client and persuaded FDA that a revised plan and progress to that plan would address FDA requirements. No FDA 483 was received.

Contract manufacturer Needed Data Integrity Program Prior to Health Canada audit

A leading cGMP contract service provider of integrated chemistry, drug discovery, development and manufacturing services to pharmaceutical and biotechnology industries was informed they would be audited by Health Canada. Q&C worked with the client to implement a data integrity governance system. The Health Canada audit went smoothly and resulted in no findings.

Testimonial

I recently attended a Q&C training session on data integrity, and found it was very informative, well organized, and easy to understand. The presenter knew the complex subject well and kept us engaged. Interactive exercises and practical examples helped me absorb this detailed subject and showed me how to apply the course content in my job.

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 September 12, 2018

$950 per participant

Price
$950 per participant
Date
12-September-2018

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Course Details

Scope: Drugs

Session Length: Half Day

Open Session dates: September 25, 2018

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 Sep 25, 2018

$350 per participant

Price
$350 per participant
Date
25-September-2018

gmp3

Course Details

Scope: Drugs, NHPs or Cannabis

Session Length: Full Day

Open Session dates: November 27, 2018

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 November 27, 2018

$950 per participant

Price
$950 per participant
Date
27-November-2018