A Journey Worth Taking — An Easier Path to Process Change Management
WEBINAR
Change management is constant in most biomanufacturing organizations and is often avoided due to perceived complexity. While changes are necessary, they can also offer the opportunity to improve process control, efficiency, or costs. In this webinar, we describe a scientific, risk-based approach to change management and a roadmap for biomanufacturers to expedite changes in their post-approval processes.
Suppliers have extensive product testing information and experience with implementing both process and product changes. By partnering with a collaborative supplier, you can leverage their support to streamline risk assessments and the change management process aligned with ICH Q12 guidance.
In this webinar, you will learn:
- Some process changes don’t need approval!
- Understanding your change — how classification impacts reporting
- How customers can benefit from their supplier’s experience and data packages
- How a ‘change mindset’ supports confident decision making
Speakers
Janmeet Anant, Ph.D
Merck
Senior Regulatory Consultant
Dr. Janmeet Anant, PMP, RAC, is a Senior Regulatory Consultant with over 25 years of experience in biopharmaceutical manufacturing, specializing in sterile injectables. He is a member of the Regulatory Governance Team at BioPhorum and part of the PDA’s Paradigm Change in Manufacturing Operations team, focusing on quality risk management and post-approval change strategies. Janmeet has held leadership roles in the Bioprocess Systems Alliance and ASME-BPE, and supports CMC submissions for mAbs, viral vectors, and ADCs in the CDMO regulatory team. He holds a Ph.D. in Pharmacology and certifications in project management and regulatory affairs.
Pascale Richert
Merck
Validation Services Consultant
Pascale Richert provides regulatory and validation expertise to biopharma customers with a focus on sterilizing filtration systems validation. For more than 25 years, she has helped drug manufacturers demonstrate that their filtration systems contribute to safe drug manufacturing. She is a member of PDA and holds a master’s degree in biochemistry and microbiology.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented December 14, 2023