Science and Risk-based Approach (for C&Q): Application of the New Guide, Installation and Verification (In Support of ASTM E2500) (E01)

2-3 June
1.2 CEUs Working Agenda
Current as of 1 May 2008
Download Working Agenda PDF, 24 KB

Don’t miss this exclusive opportunity to receive an overview of the Baseline® Pharmaceutical Engineering Guide for Installation and Verification – An Implementation Guide in Support of Science and Risk-based approaches for C&Q and In Support of ASTM E2500, currently in development. The new guide will coexist with the current C&Q Baseline Guide and provides guidance on the implementation of risk-based approaches and verification of a system under the ASTM Standard E2500 – Standard for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.

Discussion and presentations will include: how industry is beginning to transition from the original C&Q Baseline Guide to more science and risk-based approaches to meet requirements for the ASTM Standard; how the Guide aligns with GAMP® Guides and PQLI; FDA regulatory perspectives; and case studies demonstrating application and principles that begin transition from the original Guide to the new version for both new and legacy systems.

The seminar also focuses on how the new Guide incorporates concepts from ICH Q8 and Q9 guidance, and provides procedures to improve delivery of regulated manufacturing capacity by:

Improving capability and reliability of equipment and systems
Addressing associated automation to meet process requirements
Identifying and controlling risks to manufacturing process
Producing high quality products
Implementation to meet product user requirements

How You Will Benefit

At the conclusion of this session, participants will be able to:

List the subjects and overall content in the new Baseline Guide addressing the transition of historical practice to implementation of the ASTM Standard;
Examine recent examples of pharmaceutical projects moving toward the principles of the Guide and the ASTM Standard;
Explain how the guidance aligns with GAMP, other ISPE technical documents, and ISPE’s PQLI initiative; and
Understand application to the legacy system lifecycle.

Who Should Attend

Professionals involved in or having responsibility for the specification, design, commissioning and qualification, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment, as well as representatives from regulatory agencies

Communities of Practice (COPs)

Active Pharmaceutical Ingredients (API), Biotechnology (BIO), Commissioning and Qualification (C&Q), Containment, Critical Utilities (CU), Disposables, Good Automated Manufacturing Practice (GAMP), Heating, Ventilation, and Air Conditioning (HVAC), Investigational Products (IP), Packaging, Process Analytical Technology (PAT), Process/Product Development (PPD), Project Management (PM), and Sterile Products Processing (SPP)

Related Technical Documents Available from ISPE - www.ISPE.org/publications

Commissioning and Qualification Baseline® Guide