Our GMP courses, e-learning courses and GMP Forums repeatedly get great reviews by people who need to know the latest PDA and FDA information on regulatory requirements, compliance inspection findings, and GMP compliance audit trends…why is that the case?
It’s because our GMP training course experts and quality/risk management compliance consultants regularly attend the top industry conferences around the world.
They stay up to date on FDA inspection trends, TGA inspection trends, and the most recent PICS releases including PE009-14 and related Annexes, and bring that information back to companies who need to keep their employees up to date with GMP training.
Washington DC FDA Regulations Conference / GMP Training Update (PDA/FDA)
What makes our GMP training and elearning options some of the most popular training course options for the medical devices, pharmaceutical manufacturing, herbal medicines/medicinal cannabis cultivation industry and veterinary medicines manufacturing sectors is that our industry consultants regularly attend the top conferences in pharmaceutical-industry GMP and data integrity compliance.
In September 2019, Maria Mylonas – arguably the world’s greatest GMP trainer – travelled to Washington DC, USA, to attend the 2019 PDA/FDA Joint Regulatory Conference in the USA (#2019PDAFDA).
News from the PDA and FDA Joint Regulatory Conference
Early 2020: Soon we’ll be announcing our special Industry Dinner Event where Maria will share the latest FDA inspection and quality risk management insights with industry professionals (contact us for information).
Read more about the PDA and FDA Joint Regulatory Conference on her LinkedIn post about the event #2019PDAFDA.
Highlights from the PDA/FDA Joint Regulatory Conference (Washington DC)
Manufacturing Innovation and Achieving the 20/20 Vision
Learning from Failures to Implement Sustainable CAPAs
Quality Considerations for Connected Care and Devices
Current Compliance Issues and Case Studies (FDA, PDA)
Augmented Reality and Artificial Intelligence
Applying Phase-Appropriate GMP
Innovations in Aseptic Processing
Quality Systems: Focus on Change Management Program(s)
Continuous Manufacturing Update
Audit Program Effectiveness
Cell and Gene Therapy: CMC Considerations
OOS and Effective Remediation
The Evolving Regulatory Landscape
EXCERPT: FDA/PDA Program highlights and Keynote Speakers:
- Dr. Peter Marks, CBER, U.S. FDA, was the regulatory keynote speaker (2019 PDA/FDA Joint Regulatory Conference).
- Dr. Marschall S. Runge, Dean of the University of Michigan Medical School
- Louis Schmukler, SVP & President, Global Product Development and Supply, Bristol-Myers Squibb
Plus other thought-leaders and QRM experts in medical product manufacturing, over 50 regulators from the FDA and MHRA and more.
Details of the PDA/FDA Joint Regulatory Conference (September 2019): Manufacturing Innovation, Quality and Compliance: Achieving 20/20 Vision
Last updated on October 7th, 2021 at 07:42 am