Wednesday, December 24, 2025

Warmest Wishes from AAPS

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Happy Holidays

Wishing you a joyful holiday season and a prosperous new year from the AAPS College of Health, Science & Technology

Thank you for supporting us, and for being part of the AAPS community.


We look forward to a new year of learning, growth, and shared achievements together.

AAPS | 885 Sheppard Avenue West | Toronto, ON M3H 2T4 CA

Strengthen Your GMP Auditing Capability

Greetings!


Audit Readiness in Pharma Starts with Strong Auditors

In the pharmaceutical industry, auditing contractors, vendors, and suppliers is not optional. It is a core quality responsibility. Weak audits expose organizations to compliance risk, data integrity gaps, and avoidable regulatory findings. Strong audits protect product quality and patient safety.


This workshop is designed to strengthen auditing capability across the pharmaceutical and allied industries. It focuses on practical, real-world auditing skills needed to evaluate GMP compliance and Quality Systems across suppliers, contractors, and internal operations.


Participants will gain structured guidance on audit preparation, audit design, data integrity review, execution, reporting, and follow-up. The program also addresses the technical depth required to audit across different environments, including chemical APIs, biological APIs, and multiple dosage forms.


The goal is simple. Build confident auditors and support organizations in achieving consistent, controlled, stress-free audit readiness.


Who Should Attend

This workshop is ideal for professionals who conduct supplier or internal audits on a regular basis. This includes Quality Assurance professionals, internal and external auditors, and individuals involved in evaluating third-party GMP compliance. It is also highly relevant for Qualified Persons seeking to strengthen their auditing expertise and regulatory confidence.


What the Workshop Covers

Participants will receive practical training across the full audit lifecycle, including:

  • Auditing fundamentals and audit types
  • Audit planning and preparation
  • Conducting effective audits
  • Interviewing and observation techniques
  • Audit analysis tools
  • Writing clear, defensible audit reports
  • Audit follow-up and closure


Examples and hands-on exercises are integrated throughout the workshop to reinforce learning and real-world application.


Learning Outcomes

By the end of this workshop, participants will be able to:

  • Understand auditor roles, responsibilities, and audit classifications
  • Plan and structure audits aligned with regulatory and industry expectations
  • Conduct effective audit meetings, interviews, and data reviews
  • Document findings clearly and provide constructive, professional feedback
  • Consolidate audit outcomes into strong reports and corrective action plans
  • Support continuous improvement and management accountability


This workshop provides a structured, regulator-aligned approach to auditing that strengthens compliance and builds long-term audit confidence.


Be audit-ready. Be consistent. Be confident.

Date & Time

Jan 22, 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

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Tuesday, December 23, 2025

Understanding CMC Requirements for Regulatory Submissions

Greetings!


This workshop is designed to help participants build a clear, practical understanding of Chemistry, Manufacturing, and Controls (CMC) from a regulatory standpoint. CMC is one of the most critical parts of any regulatory submission, and this session focuses on why it matters, how it is assessed by regulators, and how it should be presented within the Common Technical Document (CTD) for Canada and the EU. Participants will learn how to compile and organize CMC information in a way that supports compliance, clarity, and successful regulatory review.


The session is well suited for professionals working in regulatory affairs, quality assurance, and product development within the pharmaceutical and biopharmaceutical space. It is particularly relevant for those involved in preparing, reviewing, or managing CMC content, including regulatory submission specialists, technical writers, project managers, and quality and analytical teams. Consultants and others who support regulatory submissions will also benefit from gaining a stronger understanding of how CMC expectations are applied in practice.


Participants will be guided through the role of CMC across the drug development lifecycle, from drug substance characterization and nomenclature to analytical methods and validation. The workshop also covers manufacturing processes, in-process controls, process validation, and the development of meaningful specifications for drug substances and drug products. Stability testing, stability-indicating methods, and how to manage acceptable post-approval changes are discussed in the context of regulatory expectations.


By the end of the workshop, participants will be more confident in understanding and preparing the CMC section of regulatory submissions. They will gain practical insight into how regulators evaluate CMC data, how Drug Master Files are used, and how to structure and present information clearly and effectively. The goal is to enable participants to contribute to stronger, more defensible submissions that support product quality and regulatory compliance.

Date & Time

Jan 30, 2025

9:00 AM - 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

Monday, December 22, 2025

GMP Temperature Mapping: Practical Control and Compliance

Greetings!


Temperature control is critical to maintaining the quality, safety, and integrity of pharmaceutical products. Health Canada’s Guide 0069, Temperature Control of Drug Products during Storage and Transportation, requires that drug products be handled, stored, and transported within their labeled temperature conditions to prevent excursions that may compromise product quality. Effective temperature management across ambient, refrigerated, frozen, dry ice, and liquid nitrogen conditions is essential throughout the product lifecycle.


This workshop provides a practical overview of GMP Temperature Mapping and its role in supporting regulatory compliance and operational control. Participants will explore best practices for managing temperature across a wide range of storage and transportation environments, including rooms, warehouses, freezers, fridges, incubators, trailers, tanks, and shipping containers. The session also covers when temperature mapping should be conducted, including routine assessments, following equipment or process changes, and when unexplained temperature variability is observed.


Beyond compliance, temperature mapping generates valuable data that supports real-time monitoring and informed decision-making. Through this workshop, participants will gain an understanding of how to design and execute temperature mapping studies, analyze data, prepare clear summary reports, and interpret findings to maintain consistent product conditions and support continuous improvement. The session is suitable for professionals involved in quality assurance, logistics, and regulatory compliance, as well as those seeking to strengthen their understanding of temperature control within pharmaceutical, biotechnology, and medical device environments.

Date & Time

Jan 29, 2025

1:00 PM - 3:30 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

Friday, December 19, 2025

Year-End Sale: Save 50% on Career-Focused Courses

Greetings!


As the year comes to a close, this is your opportunity to invest in your future.


Enjoy flat 50% off on all our recorded webinars and select career-advancing certificate courses.


Dive into industry-developed courses like Good Manufacturing Practices Level IIntroduction to Regulatory Affairs, or The Canadian Pharmaceutical Industry: Big Picture.


Or get ahead in industries like Cannabis, Food Technology, Food & Nutrition Management or Nutrition, Health, and SportsWhether you’re advancing your career or stepping into a new field, take advantage of this limited time sale!


Act fast - these discounts are only available until December 31st. Don’t let this opportunity pass you by!


Have questions? Contact us at info@aaps.ca or call 416-502-2277.


Book a meeting with us now to discuss how these courses can elevate your career!

Interested to know more about AAPS?

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

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