Auditing Advanced Therapeutic Medicinal Products (ATMPs)

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90.00 Minutes

CPD Hours: 1

Online

RSSL is pleased to offer a CPD webinar and podcast as part of our commitment to lifelong learning pathways in auditing. This webinar and podcast introduce the key auditing requirements for the development and manufacturing of Advanced Therapeutic Medicinal Products (ATMPs).


ATMPs represent a highly specialised series of novel products and technologies, where both the science and the technology are continuously evolving. Auditing such a specialised field, whilst adhering to the Marketing Authorisation/Clinical Trial Authorisation and aligning with business strategy, presents unique challenges.


Key topics covered include:


  • Strategies for auditing effectively where science and manufacturing processes are evolving simultaneously
  • Critical auditing timepoints and areas
  • Technical competencies for ATMPs auditors
  • Lifecycle audit plan development and how to manage associated risks

This webinar and podcast are ideal for professionals involved in ATMP development and quality assurance. Whether you are in quality control, leading audit programs, conducting audits or preparing for inspections, this session will equip you with the knowledge and skills to navigate the complexities of ATMP auditing.


A highly interactive 90 minute webinar including a presentation, discussion and Q&A, on key topics including:


  • Conducting a Risk-Based Approach to ATMP Auditing: Identifying critical audit risks to cover.
  • Setting an Effective Annual ATMP Audit Program: Strategies, particularly for campaign-based manufacturing.
  • Structuring an Individual Audit Plan: How to set and structure a comprehensive audit plan.
  • Conducting Audit Interviews: Techniques for interviewing highly technical auditees.
  • Data Reviews and Analysis: Key considerations and methodologies.



Podcast - 1 hour

A 1-hour podcast where Peter and Rebecca delve into various aspects of ATMP auditing including:


  • Interpreting GMP Part 4 and its origins
  • Critical thinking as an auditor
  • Case studies and real-world examples: auditing ATMP processes, technology and people
  • Auditor competence and experience requirements

    By participating in this webinar and podcast, you will:


    • Understand key auditing requirements for ATMP development and manufacturing.
    • Identify and manage critical audit risks using a risk based approach
    • Develop and implement an effective annual audit program
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Meet the tutors

Peter Deegan

Peter is an experienced Pharmaceutical QA professional, with over 30 years GMP, ISO 9001 Quality Systems, audit and training experience.

Rebecca Rutter

Rebecca is a Qualified Person and Responsible Person (Eligible to act as a Qualified Person under the permanent provisions) with expertise with Biotechnology products and provision of support for Advanced Therapy Medicinal Products (ATMP). She has held Director positions at some of the most prestigious pharmaceutical companies where she has specialised in setting up and running greenfield manufacturing facilities, systems, processes, supply chain and achieving strategic business milestones.

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