Henry Urbach is the founder of GMP Training, Development and Consulting. GMP TDC LLC is a New York-based consulting organization serving Life Sciences industries. Henry has 25+ years of Life Sciences experience having held positions of increased responsibility in GMP Training and QC Microbiology. His experience includes manag Read more
In order to reduce
Course Objectives:
This webinar will address the regulatory and industry viewpoints on the subject, and the rationale why each organization, as part of its risk management program, should assess the hazard that raw materials pose to its products and manufacturing processes. Ultimately, the focus should be on both patient safety and regulatory requirements.
Course Outline:
• What is a raw material and where it comes from
• Regulatory expectations and requirements
• Industry perspective
• Processing of raw materials during manufacturing
• Risks associated with raw materials
• Determining acceptance criteria
• Managing your suppliers
• Examples from recent history
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance personnel
• Quality Control personnel
• Microbiology professionals
• Regulatory and Compliance Management
• Senior Management responsible for making final decisions