Mastering Process Validation
Statistical & Biotechnological Perspectives
This two-part masterclass series brings together leading experts to provide comprehensive insights into statistical methods and advanced biotechnological process validation. Tailored for professionals across the pharmaceutical and biopharmaceutical industries, the series is a unique opportunity to elevate your expertise in validation strategies, regulatory compliance, and operational excellence.
Masterclass 1: Statistical Methods for Process Validation
Overview:
This masterclass offers an in-depth exploration of statistical methods integral to process validation. Topics include Process Performance Qualification (PPQ), Design of Experiments (DOE), and Continued Process Verification (CPV). Learn practical techniques for root cause analysis, efficient data visualization, and creating robust sampling plans.
Trainer Highlight:
Tara Scherder
Tara Scherderis a renowned statistician and educator with over 20 years of experience in integrating statistics and science in pharmaceutical manufacturing. As the principal at SynoloStats, Tara specializes in optimizing manufacturing processes and delivering actionable insights to improve quality and compliance.
Masterclass 2: Advanced Process Validation for Biotechnological Products
Overview:
Focusing on the intricacies of biotechnological processes, this masterclass delves into critical topics such as impurity clearance, microbiological risks, and ICH guidelines (Q8, Q11, Q12). Participants will gain expertise in designing scalable models, implementing control strategies, and addressing challenges unique to biopharmaceutical manufacturing.
Trainer Highlights:
Dr. Mylène Talabardon
Dr. Mylène Talabardon brings over two decades of experience in process validation, regulatory compliance, and technology transfer, having led global strategies at Merck Serono.
Dr. Hervé Broly
Dr. Hervé Broly, Vice President at Merck Serono, is a pioneer in modernized process validation and has deep expertise in Quality by Design (QbD) and continuous biomanufacturing.
Price for attending all 4 events (without recording)
5,499 $
- Interactive Masterclass
- access for 2 participants
- Dedicated Conference Manager
- Case Studies / Q&A sessions
- Access to Training Materials. (PPT/PDF)
- Certificate of completion and LinkedIn certificate
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Attend all 4 events with the add on recording option
6,499 $
- Interactive Masterclass
- access for 2 participants
- Dedicated Conference Manager
- Case Studies / Q&A sessions
- Access to Training Materials. (PPT/PDF)
- Recording access
- Certificate of completion and LinkedIn certificate
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