Deep Dive into Pharma Training Courses 

Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.

• Real World Practice:  Courses present exercises that use current problems and situations common to the industry.
• Experienced Instructors:  Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
• Global Training to Fit Your Needs:  With eLearning

Advancing Pharmaceutical Quality (APQ)
17 - 18 Oct 2024

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.

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Instructor

Michael Grischeau

Director of Data Analytics & Management Review

AbbVie Inc

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.

Commissioning and Qualification
17 - 18 Oct 2024

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.

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Instructor

Chip Bennett, PMP

Associate Director, Global CQV

CAI

GAMP® Basic Principles
17 - 18 Oct 2024

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.

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Instructor

Eric J. Staib

Vice President, Corporate Quality

Syneos

This classroom course has been updated to include the new revised GAMP^®5 Second Edition: A Risk-Based Approach to Compliant GxP Computerized Systems Guide.

GAMP® Data Integrity 21 CFR Part 11
17 - 18 Oct 2024

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.

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Instructor

Winnie Cappucci

Retired