Training
Deep Dive into Pharma Training Courses
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.
Advancing Pharmaceutical Quality (APQ)
Advancing Pharmaceutical Quality (APQ) Quality Management Maturity
30 - 31 Oct 2025
In this training, you will be led through the APQ guide series for Quality Management Maturity including how to leverage structured tools using a tested industry best-practice approach to coordinating, conducting, presenting, and reporting out on assessment outcomes. You will learn how the APQ methodology is used to improve the current state of quality and how it can benefit your organization through the Assess, Aspire, Act, Advance Framework.
APQ Guide Series
The program consists of five Good Practice Guides: one for each of the four elements of an ICH Q10 Pharmaceutical Quality System plus Cultural Excellence, bookended by an optional benchmarking tool developed by University of St. Gallen.
The APQ Guides series proves a set of tool and systematic approaches – the Assess, Aspire, Act, and Advance Framework – for organizations to advance the maturity and effectiveness of these PQS elements.
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Instructors
Tami Frederick
Michael Grischeau
Commissioning and Qualification
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
GAMP® Data Integrity 21 CFR Part 11
30 - 31 Oct 2025
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
GAMP® Basic Principles 2-Day
30 - 31 Oct 2025
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.
Instructor
Eric Staib
Training Course Venue
501 South College Street
Charlotte, NC 28202