Thursday, September 3, 2026

GMP Through the Eyes of an Inspector

Date & Time

Sep 24, 2026

2:00 PM - 4:00 PM (EST)


Workshop Options

Live & Instructor-led | Recorded | Live + Recorded.

GMP in Practice: What Inspections Expect for 2026

Greetings!


There is what GMP says on paper. And then there is what happens when an inspector starts asking questions.


Terry Pilkey knows both sides of that conversation.


Across 44 years in the pharmaceutical industry, Terry has worked in government, regulatory affairs, quality control, consulting, and auditing. During her time with the Health Products and Food Branch Inspectorate of Health Canada, she performed GMP and Medical Device inspections, giving her firsthand experience with what inspectors look for and where compliance issues tend to surface.


She later took that experience into industry, most recently as Regulatory Affairs Director at Eurofins Biopharma Product Testing Toronto. Today, she is Quality & Compliance Department Head and an executive member at AAPS Pharma.


On September 24, Terry will lead GMP in Practice: What Inspections Expect for 2026, a practical workshop built around the realities of maintaining GMP compliance.


We’ll get into the things that matter when GMP moves from a requirement to everyday practice:

  • Building stronger quality control and quality assurance practices
  • Writing effective SOPs and maintaining reliable GMP documentation
  • Investigating deviations and out-of-specification results
  • Managing production controls, validation, and change control
  • Building effective training and sanitation programs
  • Getting your people, documentation, and systems ready for inspectors and auditors


The idea is not simply to revisit GMP principles. It is to understand what good compliance actually looks like in practice, where things can go wrong, and what an experienced inspector or auditor is likely to notice.


Choose how you'd like to attend:

Live Workshop

Join Terry live for the instructor-led

workshop.

Recorded Workshop*

Learn on your own schedule with the

recorded workshop.

Live + Recorded Workshop*

Get both formats together for less than purchasing them separately.

*Recorded Workshop orders will be processed within 2-3 business days of purchase, independently of the live workshop date.

Whether you work in QA, regulatory affairs, manufacturing, documentation, product development, or another regulated function, this is a chance to learn from someone who has spent decades inspecting GMP, auditing it, and helping organizations put it into practice.


All participants will receive a Certificate of Attendance upon completion.

Interested in this workshop?

Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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Wednesday, September 2, 2026

Hello, This Fall, Go Deeper Into Regulatory Affairs

There’s Always That One Area You Want to Know Better.

If you work in or around Regulatory Affairs long enough, it happens.


A conversation turns to CMC and you realize you’d like to understand it beyond the part you normally deal with. A submission raises questions about labelling. Your work starts touching biologics or medical devices. Or you simply become curious about an area you haven’t had much reason to explore before.


That doesn’t necessarily mean you need another full program.


Sometimes, one course is enough to go deeper into something that matters to your work, or where you’d like your career to go next.


That’s the thinking behind what we’re doing at AAPS this fall.


Through September 30, our individual Professional Regulatory Affairs courses are available at 50% of their regular course fees.


Individual courses include:


Maybe you already know exactly which one you’d choose. Maybe there are two or three you’ve been meaning to understand better.


Either way, start with what’s useful to you.

Interested in AAPS College?

Register today by calling our team at 416-502-2277 or email us at info@aaps.ca.

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Tuesday, September 1, 2026

Understand What Goes Into a New Drug Submission

Date & Time

Sep 10, 2026

2:00 PM - 4:00 PM (EST)


How is the Workshop delivered?

Live. Virtual. Interactive. Instructor-led.

NDS Submissions Explained: Where Applications Break Down

Greetings!


Every new drug approval begins with understanding the regulatory pathway.


From drug development and pre-submission meetings to CTD preparation, filing and regulatory review, bringing a new drug to market involves a structured process with specific requirements at every stage.


This workshop provides a practical introduction to that process and the regulatory framework behind it.


Participants will explore:

  • How the drug development and approval process works
  • The fundamentals of New Drug Submissions (NDS)
  • Notice types and Health Canada’s Priority Review Policy
  • The role of pre-submission meetings
  • Submission formatting, filing and screening
  • The structure and purpose of the Common Technical Document (CTD)
  • Key CTD modules and their role in a submission
  • How eCTD can streamline the regulatory submission process


Designed for professionals entering Regulatory Affairs, as well as those in Quality, Drug Development and the pharmaceutical industry who want to strengthen their understanding of the submission and approval process.


Build the regulatory foundation behind successful drug submissions.



*All participants will receive a Certificate of Attendance upon completion.

Interested in this workshop?

Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

LinkedIn  Web