Thursday, April 9, 2026

GMP clarity you actually need

Greetings!


GMP is one of those things everyone knows exists, but very few teams actually execute properly across manufacturing, documentation, and quality systems. This workshop is designed to bridge that gap. Instead of going through theory, the focus is on how GMP actually applies across real pharmaceutical operations, including manufacturing, packaging, labeling, testing, and control, and what it takes to maintain compliance in a regulated environment. It also addresses what happens when things go wrong, and how non-compliance directly impacts product quality, integrity, and regulatory standing.


The session walks through GMP the way it functions in practice. It covers the core principles, management responsibilities, and how quality is maintained on the floor, along with documentation requirements such as SOPs, validation, and accurate record keeping. Participants will also gain clarity on production controls, sanitation programs, methods and specifications, and how to handle deviations and out-of-specification results. Additional focus is placed on change control, current industry expectations, and how to remain audit-ready at all times, including practical insights into handling inspectors and regulatory audits without last-minute scrambling.


This workshop is relevant for professionals across pharmaceutical, biopharmaceutical, medical device, vitamins, herbals, and allied industries, particularly those working in Regulatory Affairs, Quality Assurance, Clinical Research, Documentation, Product Submission, Project Management, Training, and Product Development. It is equally valuable for managers, supervisors, associates, consultants, and stakeholders involved in bringing products to market or maintaining compliance within regulated environments.


By the end of the session, participants will have a clearer understanding of GMP principles and how they translate into day-to-day operations, stronger capability in developing and maintaining compliant documentation, better control over quality systems and deviation handling, and a more structured approach to preparing for regulatory inspections. All participants will receive a certificate of attendance upon completion. If you are working in a regulated environment, GMP is not something you can afford to be unclear about. Register now.


You can use code SAVE20 to get 20% off as an early bird discount if you register by April 16.

Date & Time

Apr 30, 2026

1:00 PM - 3:00 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

Master the New Drug Submission Process

Greetings!


We are hosting a half-day workshop for professionals working in or alongside the drug submission process. If gaps in your regulatory knowledge are slowing you down, this session is worth your time.


The workshop covers the full New Drug Submission process - from drug development and notice types, through to submission formatting, priority review policy, and the Common Technical Document (CTD). A focused portion addresses eCTD submissions specifically, including where and why applications get screened out before they ever reach review.


It is particularly relevant for regulatory affairs specialists, drug development professionals, quality assurance personnel, and anyone involved in the preparation or filing of new drug submissions.


By the end of the session, you will have a clear, working understanding of what a compliant submission looks like, how the approval process is structured, and where most applicants go wrong.

Date & Time

Apr 24, 2026

3:00 PM - 5:00 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

Tuesday, April 7, 2026

FINAL CALL: OOS Investigations Done Right From Compliance Pressure to Controlled Confidence

Greetings!


In a GMP regulated environment, Out of Specification (OOS) results are not just deviations to be addressed. They are signals that test the strength of your quality systems. Yet in practice, OOS investigations often become reactive, inconsistent, and documentation heavy exercises that leave teams uncertain rather than confident.


This workshop is designed to change that. Led by Kevin Mueller, Instructor at AAPS College with over 25 years of pharmaceutical industry experience across Novopharm Ltd. and Teva Canada Ltd., it is built for professionals working within laboratory, QA, and regulatory functions and provides a structured and practical approach to handling OOS investigations from initial identification to final reporting, with clarity at every stage. Participants will develop a working understanding of how to interpret Out of Trend (OOT) and OOS results, apply regulatory expectations, and execute Phase 1 investigations with precision.


The session also addresses critical decision points such as remeasurement, retesting, and resampling where compliance risks often arise. Equal emphasis is placed on what truly differentiates high performing teams, including documentation discipline, clear role accountability, and the ability to draw meaningful and defensible conclusions. Real world case studies and regulatory observations are integrated throughout to ensure alignment with actual industry expectations.


By the end of the workshop, you will not only understand how to investigate OOS results but also how to do so in a way that is consistent, audit ready, and aligned with global regulatory standards. This session is particularly relevant for quality assurance professionals, regulatory affairs specialists, laboratory analysts, and supervisors responsible for maintaining compliance and product quality within GMP environments.

All participants will receive a certificate of attendance along with a comprehensive course manual designed for ongoing reference.


If OOS investigations are part of your responsibility, this is not just another training. It is a shift towards controlled, confident, and defensible quality practices.

Date & Time

Apr 13, 2026

1:00 PM - 3:00 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

NHP Level 3 is Here - Go Beyond Approval

Greetings!


Level 3 of our Natural Health Products workshop series moves beyond initial approval and into the ongoing regulatory responsibilities that govern products once they are on the market. Building on earlier sessions covering classification, licensing, manufacturing, and labelling, this workshop focuses on maintaining compliance across the full product lifecycle in Canada and beyond.


The session provides a practical overview of Canadian post-market requirements, including importation, exportation, and distribution. Participants will gain clarity on the responsibilities of licence holders, importers, and distributors, along with key exemptions for personal use and clinical trials. The workshop also introduces Master Files and their role in protecting proprietary ingredient information while supporting product licence and clinical trial applications.


A key focus is clinical trial oversight for NHPs. Attendees will learn when authorization is required, how trial phases differ, and what Health Canada expects in terms of applications, ethics approval, and adverse reaction reporting. The session also covers pharmacovigilance requirements, helping participants identify, assess, and report adverse reactions in line with regulatory expectations.


In addition, the workshop provides a comparative overview of international frameworks, including U.S. dietary supplement regulation under DSHEA and FDA oversight, offering insight into global compliance considerations.


This workshop is designed for professionals and students working with Natural Health Products and dietary supplements who need a practical understanding of post-market and global regulatory requirements. It is particularly relevant for those in regulatory affairs, quality assurance, product development, manufacturing, import/export, compliance, and clinical research roles.


The session is led by Andreea Simo, a regulatory affairs and quality professional with experience across global organizations such as PepsiCo and Jamieson Vitamins, as well as consulting firms and start-ups. Her background ensures a practical, industry-aligned understanding of how Natural Health Products are managed beyond approval and throughout their lifecycle.

Date & Time

Apr 17, 2026

11:00 AM - 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, April 2, 2026

Master the New Drug Submission Process

Greetings!


We are hosting a half-day workshop for professionals working in or alongside the drug submission process. If gaps in your regulatory knowledge are slowing you down, this session is worth your time.


The workshop covers the full New Drug Submission process - from drug development and notice types, through to submission formatting, priority review policy, and the Common Technical Document (CTD). A focused portion addresses eCTD submissions specifically, including where and why applications get screened out before they ever reach review.


It is particularly relevant for regulatory affairs specialists, drug development professionals, quality assurance personnel, and anyone involved in the preparation or filing of new drug submissions.


By the end of the session, you will have a clear, working understanding of what a compliant submission looks like, how the approval process is structured, and where most applicants go wrong.

Date & Time

Apr 24, 2026

3:00 PM - 5:00 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