Learn more about the latest pharmaceutical manufacturing quality control and sterility testing trends from experts working in the field, and discover advances in regulatory compliance,growth promotion testing, environmental monitoring and more.
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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.
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.
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.
Featured speaker: Dr. Tarun Chugh (Ph.D., Microbiology) is a Pharmaceutical professional with more than 32 years of rich experience in Microbiology Quality Control and Quality Assurance Department. Presently CEO of SIMco Pharma Consultancy and working at Ahmedabad.
Featured speaker: Gilberto Dalmaso, Technical & Scientific Director at Palladio Consulting, has over of 35 years of experience in pharmaceutical microbiology and sterility assurance.
Stay up-to-date with current regulatory requirements and approaches in handling day-to-day laboratory challenges in the field of Growth Promotion Testing
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.
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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