At AAPS, we’re dedicating the month of March to celebrating all things Good Manufacturing Practices (GMP) with Manufacturing March! Whether you’re looking to sharpen your auditing skills, master temperature mapping, or stay ahead of the latest GCP updates, our expert-led training sessions and workshops are designed to keep you at the forefront of pharmaceutical compliance. Join us for a month of learning, networking, and industry insights as we dive deep into the world of GMP!
We’re hosting three essential workshops to give you hands-on, real-world insights into GMP compliance, quality assurance, and pharmaceutical regulations. If you’re ready to take your pharmaceutical career to the next level, now is the time to get involved.
Read on to discover how each workshop can help you build critical industry skills and why you don’t want to miss out on this year’s Manufacturing March at AAPS!
This GMP workshop will highlight strategies to ensure stress-free audit readiness.
GMP Compliant Temperature Mapping
Date: March 13, 2025
Temperature control isn’t just about compliance but also about protecting product integrity. Every storage condition, from warehouses to transport vehicles, must meet Health Canada’s GUI-0069 standards. But how do you ensure that storage temperatures remain stable and within acceptable limits?
This workshop will teach you how to map temperature fluctuations and prevent costly cold chain failures that can compromise product safety.
What You’ll Learn:
- Introduction to Temperature Mapping
- Understanding the importance of regulatory compliance
- Defining a quality pharmaceutical product
- Strategies for achieving compliance
- Implementing environmental controls
- Practical application of controls in storage environments
- Selecting appropriate data loggers
This workshop is necessary if you work in quality assurance, logistics, or regulatory compliance.
This GMP workshop will teach you how to map temperature fluctuations.
Future-Proofing Clinical Trials: Essential GCP Updates You Need to Know
Date: March 20, 2025
Clinical trials are evolving fast, and the new ICH E6 (R3) Good Clinical Practice (GCP) guidelines are bringing significant changes. Staying informed is crucial if you’re involved in clinical research, trial monitoring, or regulatory compliance.
This brand-new workshop at our pharmaceutical institute breaks down the latest updates to GCP regulations and shows you how to apply them in real-world clinical trials.
What You’ll Learn:
- Introduction to ICH E6(R3) and the evolution of GCP
- Modernized Trial Design and Conduct
- Enhanced Use of Technology
- Improved Trial Design Flexibility
- Patient-Centric Approach
- Regulatory and Compliance Considerations
This session is ideal for clinical research professionals, project managers, regulatory experts, and medical writers.
This workshop at our pharmaceutical institute covers the latest updates to GCP regulations.
OOS Investigations for Testing Laboratories in a GMP Environment
Date: March 27, 2025
Identifying and addressing Out-Of-Specification (OOS) results in the pharmaceutical industry is more than a regulatory requirement: it’s a critical quality control measure. Ensuring thorough OOS investigations and maintaining robust quality systems within laboratories is essential for regulatory compliance and product quality. However, many professionals find this process challenging and complex.
This workshop will provide participants with a structured approach to OOS investigations, equipping them with the knowledge to handle non-conforming results effectively. Designed for laboratory analysts, quality assurance professionals, and regulatory affairs specialists, this session will cover everything from root cause analysis to corrective and preventative actions.
What You’ll Learn:
- Out-of-Trend (OOT) Results
- Review of Relevant Guidelines
- Regulatory Observations: Key Examples
- Quality Documentation for Supporting OOS Investigations
- Roles and Responsibilities in OOS Investigations
- Additional Laboratory Testing: Hypothesis, Remeasurement, Retesting, and Resampling
- Investigating OOS Results – Phase 1 (Practical Exercise)
- Concluding the Investigation and Evaluating Results
- Reporting Test Results Effectively
- Case Studies in OOS Investigations
- Strategies for Minimizing Future OOS Results
This workshop is essential for professionals managing laboratory investigations, ensuring regulatory compliance, and maintaining product quality.
Why You Can’t Afford to Miss These Workshops at Our Pharmaceutical Institute
At AAPS, we’re committed to helping you succeed in the pharmaceutical industry. These workshops provide practical, career-boosting insights that you can apply immediately in your job.
Whether you aim to strengthen your GMP knowledge, develop skills for audit readiness, or stay ahead of clinical research regulations, our workshops will equip you with industry-relevant expertise.
Manufacturing March is the chance for pharmaceutical industry professionals to invest in their pharmaceutical careers and gain a competitive edge in the pharmaceutical industry.
Discover how our GMP workshops can enhance your career!
Contact AAPS for more information.