Tuesday, May 12, 2026

24 Hours Left: Save 20% on GMP Inspection Readiness Workshop

Greetings!


One missing signature. One weak investigation. One uncontrolled change.

That’s sometimes all it takes for an observation to escalate into a serious GMP concern.


As regulatory expectations continue to tighten across pharmaceutical and healthcare manufacturing environments, inspection readiness is no longer optional - it’s operational.


This practical 2-hour virtual workshop is designed to help GMP professionals strengthen the exact areas regulators focus on most during inspections.


🚨 Early Bird Offer Ends in 24 Hours 🚨

Register before May 13 and save 20% using code SAVE20.

The webinar fee is $199 + HST. With Ontario HST (13%), the regular total is $224.87.

With the 20% Early Bird discount, your price is reduced to $179.90 including HST (regularly $224.87).


What the workshop covers:

• GMP fundamentals and the inspection mindset

• GDP and ALCOA+ principles

• Deviations, investigations, and root cause analysis

• CAPA structure and effectiveness verification

• Data integrity expectations and audit trail review

• OOS handling and two-phase investigations

• Risk-based change control

• Validation, qualification, and maintaining the validated state


What participants will walk away with:

• Practical inspection-readiness tools and checklists

• Stronger understanding of regulator expectations

• Real-world examples and scenario-based learning

• More confidence handling GMP documentation and investigations

• A certificate of attendance upon completion


Who should attend:

• QA and QC professionals

• Regulatory affairs professionals

• Manufacturing and operations teams

• Anyone involved in deviations, CAPA, batch records, or change control

• Professionals newer to GMP environments looking to build stronger foundations


The workshop will be led by Terry Pilkey, a GMP and regulatory expert with 44 years of experience across both industry and government. Her background includes GMP and Medical Device inspections with Health Canada, along with senior regulatory and quality leadership roles across pharmaceutical, natural health product, medical device, and medicinal cannabis sectors. She currently serves as an executive member and Head of Quality & Compliance at AAPS Pharma.

Date & Time

May 29, 2026

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


How is the Workshop delivered?

Live. Virtual. Interactive. Instructor-led.

Interested in this workshop?

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

LinkedIn  Web

Monday, May 11, 2026

50% Off Until May 31 | Regulatory Affairs for Natural Health Products

Greetings!


Natural Health Products continue to be one of the fastest-growing segments across the healthcare and wellness industry - but bringing compliant products to market requires a strong understanding of regulatory expectations, licensing pathways, GMP requirements, and post-market obligations.


For a limited time, AAPS College is offering 50% OFF the PRA205 Regulatory Affairs Natural Health Product course until May 31.


This practical regulatory affairs course is designed to help professionals and aspiring regulatory specialists build a strong working understanding of the Natural Health Product (NHP) regulatory landscape across Canada, the United States, and key international jurisdictions.


Participants will explore critical areas including:

• Product Licence Applications (PLA)

• NHP classification and submission requirements

• GMP and Quality Assurance expectations

• NHP labelling and packaging regulations

• Claims and advertising considerations

• Site licensing and submission management

• Importation and distribution requirements

• Clinical trials and adverse event reporting

• Comparative regulatory frameworks across Canada, the US, and the EU


Through practical examples and real-world case studies, learners will gain valuable insight into how NHP submissions are managed from product development through post-market compliance.


Whether you are working in regulatory affairs, quality assurance, compliance, manufacturing, or looking to enter the Natural Health Products (NHP) and wellness sector, this course provides practical, career-focused regulatory knowledge designed to support success in the regulated health products industry.


Offer valid until May 31.

Interested in AAPS College of Health, Science and Technology?

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

LinkedIn  Web

🚨FINAL CALL🚨 Medical Device Regulatory Pathway (Canada)

Greetings!


A medical device rarely gets held back because the science isn’t strong. More often, it’s a decision. A classification that shifts the entire requirement. A document that doesn’t land the way it should. A submission that looks complete, but doesn’t move.


From the outside, the pathway in Canada appears structured. Classes are defined, regulations are documented, and the steps seem clear. But once you’re inside the process, it becomes a sequence of calls that determine whether something progresses smoothly or slows down without warning.


This 2-hour workshop is built around that reality. It walks through how medical devices are regulated under Health Canada, how risk-based classification actually shapes the pathway, and how market authorization is approached when these decisions are made in practice. The focus is on understanding not just what is required, but how it is applied, where submissions tend to face resistance, and how regulatory strategy supports both approval and what follows after.


The session is led by Cecile Cualing, a pharmacist and regulatory affairs professional who has worked across both pharmaceutical and medical device environments. Her experience spans Health Canada, the U.S. FDA, and notified bodies, but what distinguishes her approach is where she started. Her early work in pharmaceutical manufacturing, in formulation and quality control, shaped how she understands regulation today. It is not separate from development or production. It sits within it. That perspective carries through her regulatory work, where she has supported market authorization and lifecycle management in real settings, and it informs how she explains decisions that are often reduced to checklists.


All participants will receive a certificate of attendance upon completion.

Date & Time

May 14, 2026

12:00 PM - 2:00 PM (EST)


How is the Workshop delivered?

Live. Virtual. Interactive. Instructor-led.

Interested in this workshop?

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

LinkedIn  Web

Thursday, May 7, 2026

DEADLINE APPROACHING FAST: Medical Device Regulatory Pathway (Canada)

Greetings!


A medical device rarely gets held back because the science isn’t strong. More often, it’s a decision. A classification that shifts the entire requirement. A document that doesn’t land the way it should. A submission that looks complete, but doesn’t move.


From the outside, the pathway in Canada appears structured. Classes are defined, regulations are documented, and the steps seem clear. But once you’re inside the process, it becomes a sequence of calls that determine whether something progresses smoothly or slows down without warning.


This 2-hour workshop is built around that reality. It walks through how medical devices are regulated under Health Canada, how risk-based classification actually shapes the pathway, and how market authorization is approached when these decisions are made in practice. The focus is on understanding not just what is required, but how it is applied, where submissions tend to face resistance, and how regulatory strategy supports both approval and what follows after.


The session is led by Cecile Cualing, a pharmacist and regulatory affairs professional who has worked across both pharmaceutical and medical device environments. Her experience spans Health Canada, the U.S. FDA, and notified bodies, but what distinguishes her approach is where she started. Her early work in pharmaceutical manufacturing, in formulation and quality control, shaped how she understands regulation today. It is not separate from development or production. It sits within it. That perspective carries through her regulatory work, where she has supported market authorization and lifecycle management in real settings, and it informs how she explains decisions that are often reduced to checklists.


All participants will receive a certificate of attendance upon completion.

Date & Time

May 14, 2026

12:00 PM - 2:00 PM (EST)


How is the Workshop delivered?

Live. Virtual. Interactive. Instructor-led.

Interested in this workshop?

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

LinkedIn  Web