QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning & Qualification

Complimentary
Learning Level: Intermediate
Session Length: 2 hours

This webinar is the first in a series of ten, presented by the ISPE Commissioning & Qualification CoP, to provide clarifications and current industry best practices for implementation of Quality Risk Management (QRM) based Commissioning and Qualification in support of facilities, systems, and equipment fit for intended purpose or "Qualified" to ensure product quality and patient safety. This webinar will address three main topic areas followed by a Q&A session.

• Topic 1: The purpose of this ten-part series and the topics that will be addressed.
• Topic 2: The rational and advantages for QRM Commissioning & Qualification implementation.Elements addressed include enhanced assurance of product quality and patient safety, speed to market, the relationship between ICH Q10 Control Strategy and pharmaceutical manufacturing, the relationship between QRM and QbD (Quality by Design), providing the Quality Unit focus for Qualification, the relationship between CQA, CPP, CA/controls, CDE/critical aspects, robust manufacturing processes and enhanced compliance.
• Topic 3: Enablers of the QRM Commissioning & Qualification process. The focus for this presentation will be the identification of the key enablers of the QRM Commissioning & Qualification implementation with the focus being on Good Enginering Practice (GEP). The relationship between GEP application to meet cGMP (qualification) expectations will be addressed. Impact pact on the overall site PQS and supporting Quality Systems (QS) will be addressed. How the Engineering Quality Process (EQP) can achieve the appropriate amount of quality oversite of GEP with defined Quality focus is explained. Understanding how GEP application is applied over the project execution lifecycle.

Learning Objectives

1. Understanding of the Commissioning & Qualification CoP QRM Commissioning & Qualification 2025 ten-part webinar series and how it can advance implementation of the QRM based integrated Commissioning & Qualification program or transitioning from traditional qualification approaches. Realization that adopting a QRM approach for Commissioning & Qualification is the best way to ensure speed to market, product quality, and patient safety.
2. Understanding the advantages provided by the QRM Commissioning & Qualification approach in terms of the use of science and risk, manufacturing control strategy determination, Qality by Design, lifecycle integrated commissioning and qualification testing and documentation (verification), and finishing with Acceptance and Release to support PQ and PPQ/PV. Realizing that the relationship between CQA, CPP, CA, and CDE is the basis for both successful and efficient project execution and product lifecycle management.
3. Insight as to how a robust application of GEP is the "Umbrella" under which an efficient QRM Commissioning & Qualification process is conducted. Understanding that successful QRM Commissioning & Qualification implementation will require modification of the site PQS, supporting traditional approaches to qualification, so the application of GEP can meet the needs required to meet the GMP requirements of FSE fit for intended purpose. Understanding of the EQP (Engineering Quality Proces

Speakers

Steven Wisniewski

Principal Consultant

CAI Retired

Hazem Eleskandarani

Senior Director, Global Quality Engineering

CSL Behring

Nick Haycocks

Mechanical Engineer, Senior Specialist Quality Assurance

Retired

Lori Kim

Vice President, Technical Operations

PSC Biotech Corp