ISPE Training: Science and Risk-based Commissioning and Qualification - Applying the ISPE Baseline Guide, Volume-5, Second Edition: Commissioning and Qualification (T40)

Pan Pacific Singapore |  22-23 Aug 2023

Overview

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.
NOTE: It is strongly recommended that participants be familiar with basic concepts of commissioning and qualification prior to attending this course.

Who Should Attend

  • Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach.
  • Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.

What You Will Learn

  • Applying the QRM C&Q Process Flow
  • Principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness-for-use/qualification as required by major global regulatory authorities;
  • Improving the ability to consistently meet documented process requirements;
  • Controlling risks within the manufacturing process;
  • Producing high-quality products and consistent operation to meet product user requirements.
  • Guidance is provided on how to transition an organization's approach quality systems and establishing the appropriate of level of quality oversight for Commissioning and Qualification that incorporates a science and risk-based approach

Led By

  • Pierre Winnepenninckx

CEO, No deviation Pte., Ltd.

SME, Commissioning & Qualification, ISPE Singapore Affiliate and ISPE International CoP

  • Phil Jarvis

Director, Integrated C&Q and Paperless Strategy - Veqtor Solutions

Registration Fee

T40 fees

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