Hear from Patheon Pharma Services about their requirements for compliance and data integrity, and how they overcame the challenges encountered when evaluating and implementing new equipment. Adhering to 21 CFR Part 11 is an important part of compliance but does not guarantee data integrity. Learn how and why Patheon implemented both FTIR Spectroscopy and a Chromatography Data System in different areas of their workflow to meet data integrity needs and the importance of these to the business.
Patheon Pharma Services provides industry-leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers. With more than 55 locations around the world, providing integrated, end-to-end capabilities across all phases of development, including API, biologics, viral vectors, cGMP plasmids, formulation, clinical trials solutions, logistics services and commercial manufacturing and packaging.
- Learn how to navigate challenges encountered when meeting Data Integrity guidelines
- Understand compliance risks associated with electronic and paper data (ALCOA+)
- Hear how the right choice of FTIR instrument can enable data integrity
- Learn about the evolution of Mass Spectrometry in Pharma QC
- Understand importance of selecting the right CDS to ensure data integrity and compliance for MS
Who should attend:
- Analytical science and technology transfer leaders
- Analytical scientists working in biopharmaceutical manufacturing
- QA/QC managers
Run time: 60 minutes
Manager, Proactive Quality and Data Integrity
Senior Quality Specialist
Patheon Pharma Services
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