Auditing against the New Annex 1 Steriles Guideline - CPD (eLearning)

2.50 Hour/s

CPD Hours: 2


This eLearning CPD module provides supporting documents, presentation, podcast and video content from the recent Auditing against the New Annex 1 Steriles Guideline webinar. 

RSSL will be releasing similar CPD materials that form part of our CPD programme that supports RSSL’s new Auditor Career Pathway.

Our new Auditor Career Pathway maps the journey for aspiring and experienced auditors to receive life-long skills and knowledge development, leading the way through the key career stages and helping to choose the learning intervention that is right for them. 

The CPD content is essential for those that missed the original Auditing against the New Annex 1 Steriles Guideline webinar, but especially relevant for Quality auditors and GMP professionals involved in auditing sterile processes and facilities. Specifically, individuals responsible for developing audit programs, conducting audits, and ensuring compliance with Annex 1 guidelines will find this session particularly beneficial.

The content provided provides invaluable insights and practical strategies for auditing against the New Annex 1 Steriles Guideline, ensuring participants are well-equipped to navigate the complexities of steriles manufacturing and maintain compliance with regulatory standards.

The materials and content in this CPD module, include :

  • A Whitepaper covering EU GMP Annex 1 and the Audit Process
  • A Podcast between Peter Deegan and Clive Brading covering the Sterile process sterile facility auditing
  • A PDF flyer of the RSSL Auditor Career Pathway
  • The Presentation from the recent Webinar, Auditing against the New Annex 1 steriles guideline
  • And the full video recording of the same webinar

    By the end of this CPD content, participants will:

    • Gain an understanding of the expanded guidance provided by EU GMP Annex 1 for sterile manufacturers
    • Learn strategies for structuring an audit programme against Annex 1 requirements, considering the complexity of sterile manufacturing.
    • Explore critical aspects of sterile manufacturing, including contamination control strategy, risk management, cleanrooms, sterilization technologies, cleaning and disinfection, environmental monitoring, vendor approvals, and training.
    • Receive practical recommendations for auditing key areas such as contamination control, risk management, and cleanroom operations.
£ 190

ex VAT

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Auditor Career Pathway

As a Pharmaceutical auditor you will play a critical role in upholding integrity, reliabilty and patient safety in the pharmaceutical supply chain. Your role involves ensuring compliance with regulations such as Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and quality standards.