Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems Complimentary Learning Level: Intermediate Session Length: 1 hour The data generated at clinical sites are the foundation of clinical trials...
Learning Level: Intermediate -
The SARS-CoV-2 worldwide pandemic has presented a significant challenge to business continuity for pharmaceutical manufacturing. It has led to Industry re-assessing the virus control framework, and in particular, any challenges that this may present to the mitigations currently in place. This presentation will focus on the SARS-CoV-2 situation and factors to be assessed in a GMP Biopharmaceutical manufacturing facility and whether they present a secure virus mitigation strategy to protect the product from contamination from this and other viruses.
- The factors involved in the virus control framework for a Biopharmaceutical manufacturing facility with reference to ICH Q5A.
- The planning activities required in order to prepare for a novel virus challenge to manufacturing facilities.
- Ongoing virus risk management and mitigations.
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