Auditing Against the New Annex 1 Steriles Guideline - CPD (eLearning)
This module is designed to provide invaluable insights and practical strategies for auditing against the Guideline, ensuring participants are well-equipped to navigate the complexities of steriles manufacturing and maintain compliance with regulatory standards.
If you are considering RSSL's eLearning programmes for over 50 participants, tailored package options are available. Contact trainingsales@rssl.com or call +44 (0)118 918 4000 to discuss your requirements.
This module is relevant for quality auditors and GMP professionals involved in auditing sterile processes and facilities. It is especially useful to those responsible for developing audit programmes, conducting audits and ensuring compliance with Annex 1 guidelines.
This module is one of many RSSL CPD materials made available to delegates wishing to pursue or develop their career in pharmaceutical auditing. RSSL’s Auditor Career Pathway maps the journey for aspiring and experienced auditors to gain life-long skills and advanced knowledge at each of the key career development stages; foundation, practitioner, professional and CPD.
The materials within this self-paced module include:
A Whitepaper covering EU GMP Annex 1 and the Audit Process
Access to RSSL’s 45-minute podcast covering sterile processes and sterile facility auditing
The presentation content from RSSL’s Auditing against the Annex 1 Steriles guideline webinar
The full 1.5 hour video recording of RSSL’s Auditing against the Annex 1 Steriles guideline webinar
By the end of this CPD module, participants will have:
An understanding of the expanded guidance provided by EU GMP Annex 1 for sterile manufacturers.
An awareness of strategies for structuring an audit programme against Annex 1 requirements, considering the complexity of sterile manufacturing.
Knowledge of the critical aspects of sterile manufacturing, including contamination control strategy, risk management, cleanrooms, sterilization technologies, cleaning and disinfection, environmental monitoring, vendor approvals, and training.
Practical recommendations for auditing key areas such as contamination control, risk management, and cleanroom operations.
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
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