2nd Edition
Introduction to Phase-appropriate Regulatory & Compliance Expectations for....
Online Masterclass
- October 1st – 2nd 2024
- 09:00 AM - 01:30 PM EDT (UTC-4)
Trainer
Dr. Margit Holzer
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anticipation of the approaching event
Introduction
This masterclass offers an in-depth examination of the regulatory requirements and compliance strategies crucial for the successful development of biopharmaceutical products. Over two days, participants will explore essential topics including ICH guidelines, EMA and FDA process validation guidance, and phase-appropriate CMC content for clinical development. The course covers key elements such as analytical and stability aspects, phase-appropriate GMP requirements, and quality expectations for R&D studies. Attendees will gain practical insights into data integrity and learn from real-world case studies, enhancing their ability to apply theoretical knowledge
to practical scenarios.
This masterclass is ideal for professionals in regulatory affairs, quality assurance, CMC project management, and related fields seeking to deepen their expertise and stay current with industry standards. Equip yourself with the knowledge needed to navigate the complex regulatory landscape and ensure the quality and compliance of biopharmaceutical products.
Who Should Attend
- Regulatory Affairs Manager
- Quality Assurance Specialist
- CMC Project Manager
- Biopharmaceutical Scientist
- GMP Compliance Officer
- Process Development Scientist
- Analytical Development Scientist
- Pharmaceutical Quality Control Analyst
Meet The Trainer
Dr. Margit Holzer boasts over 30 years of industry experience, having contributed to the development of more than 50 different products. She specializes in process, product, and analytical method development for biopharmaceuticals. Her extensive expertise spans all phases of bioprocessing, including preclinical production, clinical production, and large-scale commercial supply.
Margit’s career began at Boehringer Ingelheim, where she eventually established and led the new division of Manufacturing Sciences. She later served as Quality Director and then as Technology, R&D, and Innovation Director for NOVASEP in France before joining Ulysse-Consult. In her consultancy role, she assists clients in evaluating, optimizing, and developing processes, analytics, and technologies, including innovative solutions for upstream and downstream processing and formulation.
Margit has delivered numerous courses on bioprocess validation, helping delegates understand the guidelines and steps necessary to ensure compliance. Drawing on her extensive experience, she provides a wealth of case studies, examples, and exercises during her courses.
