On-Demand Webinar – The Changing Face of cGMP
The First of Our Three-Part Podcast Series, “The Road to Quality Management Maturity (QMM)”
Peter Baker and Bob McDowall discuss the transformation of current Good Manufacturing Practice (cGMP) in the pharma industry in response to regulatory and digital changes.
They explore the importance of:
- The integration of risk-based approaches into cGMP compliance
- Software and system qualification
- Data integrity by design and proper audit trail management
- Aligning digital systems with existing business processes
- Employee empowerment and engagement
The speakers also look at the implications of recent regulatory guidance and the need for a scientifically sound, risk-based approach to managing variability in manufacturing processes.
2nd webinar in our series – Effective Change Management and Lab Digitalization?
3rd webinar in our series – QMM – What It Is and If It Matters?
Speakers
Peter Baker
Peter Baker spent 11 years working as a U.S. FDA drug investigator and was the FDA's Investigator of the Year in 2013. He has substantial experience in uncovering serious breaches in data integrity and has a special interest in big data management and compliance with Annex 11/21 CFR Part 11. Peter now works as an independent consultant helping companies to improve the quality of medicines through good data management.
Bob McDowall
Bob is an analytical chemist with over 50 years of experience in the pharma and life sciences industry. In particular, he has over 35 years of experience in automating laboratories and providing consultancy and validation advice about laboratory computerized systems and informatics, especially LIMS and CDS.
Gunnar Danielson
Gunnar Danielson leads METTLER TOLEDO's software solutions business development team while having a core focus on digitalizing laboratories and on systems integration. Drawing on his 25 years in computer systems and business, Gunnar has extensive experience in laboratory workflow automation and data integrity. He also contributes regularly to evolving industry standards and regulatory conversations.
