Training

Join us in person for hands-on training that delivers practical solutions to your company's critical challenges. Through interactive sessions and direct engagement with industry experts, you'll gain actionable strategies to optimize costs, improve process efficiency, enhance production quality, and ensure regulatory compliance. This face-to-face learning experience offers unique networking opportunities and real-time problem-solving with peers and instructors.

Key Benefits:

• Real World Practice: Courses present hands-on exercises and interactive discussions using current problems and situations common to the industry.
• Experienced Instructors: Learn directly from subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
• Personalized Learning Experience: Benefit from face-to-face interaction, direct Q&A opportunities, and valuable networking with industry peers and experts.
• Interactive Workshop Format: Engage in collaborative problem-solving and gain practical insights through in-person demonstrations and group exercises.

22 - 23 Oct 2026

Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.

Instructor

Steven Wisniewski

Retired Principal Consultant

Self Employed

22 - 23 Oct 2026

GAMP® AI guidance provides a pragmatic and effective framework for achieving AI-enabled computerized systems that are fit for intended use and aligned with current regulatory expectations. This course introduces participants to the requirements for AI-enabled computerized systems and internationally recognized methods of meeting those requirements.

Participants will be equipped to apply a pragmatic, cost-effective good practice framework that supports the development of AI-enabled computerized systems that are high quality, effective, fit for intended use, and compliant with relevant regulations. The training will also cover the key principles and practices presented in the guide for the design, development, operation, and use of AI.

Instructor

Eric Staib

Vice President, Corporate Quality

Syneos Health

22 - 23 Oct 2026

This course has been updated to include the new revised GAMP® 5 Second Edition. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.

22 - 23 Oct 2026

This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

Instructor

Winnie Cappucci

Retired

Bayer HealthCare