Pharma Microbiology Resource Library

Aseptic Process Validation – A risk-based approach

In this webinar, we will discuss the principles of aseptic process validation based on current regulatory expectations and industry best practices, and evidenced via supporting case studies. Plus, hear more about the risk assessment approach and critical success factors for effective media fill simulations.

Featured speaker: Shanshan Liu, Technical Director at No Deviation, has over 15 years of professional experience in the field of quality and compliance, regulatory, process development and engineering, process automation, CQV, and project management of bio/pharm projects.

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Risk-based approach for environmental monitoring

The European Union (EU) GMP and PIC/S Annex 1 requires a contamination control strategy and a risk-based environmental monitoring program is a core part of this. In this webinar the use of quality risk management to understand your process will be discussed covering: identification of hazards, assigning sample types, selecting monitoring locations and establishing sampling plans.

Featured speaker: Dr. Tim Sandle a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester, with over thirty years’ experience of microbiological research, quality assurance, and biopharmaceutical processing.

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Learn more about the link between Pharma 4.0 and data integrity, and related systems and technologies. Key topics include the role of digital transformation in improving operational efficiencies and the critical issues facing pharmaceutical manufacturers, as well as the benefits of LIMS including key features and planning for implementation. Attendees will delve into the benefits of connected lab workflows, improved data integrity, and advanced analytics capabilities and how this can benefit an organization.

Featured speaker: Guy Carpenter, APAC Technical Sales Manager, Digital Science Solutions, Thermo Fisher Scientific

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In this webinar we talk about cell therapy production, where sterility testing is vital for helping ensure the quality and safety of the final product. Due to the fast-paced nature of the production process and the limited shelf-life of cell therapy products, it is crucial to detect and prevent contamination as early as possible. Hear more about how rapid sterility testing helps enable the discovery and resolution of potential contamination sources promptly, helping reduce the risk of product loss and unexpected production delays.

Featured speaker: Seth Peterson, Senior Manager, Application Scientists, BioProduction Group, Thermo Fisher Scientific 

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Biopharma environmental monitoring: Root cause analysis best practices and implications

• Key actions and components for a successful investigation, current environmental monitoring trend data and identification of microorganisms

• Procedures and best practices for cleanrooms to accurately identify contamination sources and assess impact on product quality

Featured speaker: Nand Kishore Khandelwal, PhD, founder and director of Kaliber Pharma Solutions, has over 32 years of experience with a progressive career path in managing regulatory compliance, quality assurance, quality control, validations and microbiology. 

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Featured speakers:

• Dr. Tarun Chugh Ph.D., Microbiology, SIMco Pharma Consultancy
• Julie Elston, Senior Product Manager - Identification - Thermo Fisher Scientific

Stay up-to-date with current regulatory requirements and approaches in handling day-to-day laboratory challenges in the field of Growth Promotion Testing

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Featured speaker:

• Dr. Tarun Chugh, Ph.D., Microbiology, SIMco Pharma Consultancy

Join us for our two-part webinar series dedicated to the theoretical and practical approach to Environmental Monitoring and Media Fill in pharma and biopharma companies.

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Featured speakers:

• Dr. Tarun Chugh, Ph.D., Microbiology, SIMco Pharma Consultancy
• Jessica Danaher, Senior Global Pharma & Biopharma Marketing Manager, Thermo Fisher Scientific

Learn more about approaches and requirements for microbial identification, as well as an introduction to B. cepacia testing in pharma and biopharma companies.

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