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Web Seminar Agenda: 1:00 – 1:20 Login & Setup
1:20 – 1:30 Introduction
1:30 – 2:30 "Presentation" 2:30 – 2:45 Final Thoughts
2:45 – 3:00 Break
3:00 – 3:30 Q&A
For a complete pricing structure, please click here Early Bird Deadline: Friday, November 14, 2008
Registration Deadline: Tuesday, November 25, 2008
Who Can Benefit: Any pharmaceutical, biotech, biologic or medical device company’s regulatory affairs or quality personnel including: - QA/QC Personnel and Management
- Internal Auditors
- Regulatory Affairs
- Education/Training Managers & Personnel
- GMP/GLP Compliance
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Speaker: John R. Godshalk, Ex-FDA
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Preparing and planning for an FDA inspection plays a vital role in positioning a facility and its personnel to handle the inspection efficiently, as well as reducing the apprehension that a company faces when going through the inspection itself. This all-inclusive live web training course will explore how best to prepare for FDA and other regulatory inspections, as well as provide participants with a description of what to expect for pre-approval and biennial inspections, and how to position your company for a successful inspection. This course will also cover the strategies for a successful inspection, inspection schedules, logistics issues, inspection agendas, how regulatory authorities prepare for inspections and more. Learning Benefits: Gain a better understanding of what the FDA looks for when inspecting biologics and biotech facilities Understand the process of the inspection and what to expect Understand what is emphasized in the pre-approval inspection Identify good practices and behaviors during the inspection Avoid pitfalls and missteps during the inspection Discover how best to prepare for a regulatory inspection Know how to respond to a 483 or list of inspectional observations
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Areas of Expertise Evaluation of API production, sterilization, equipment cleaning, personnel monitoring, aseptic processing, lyophilization, quality systems, and finishing operations Pre-submission review and support Regulatory strategy development Internal training programs on cGMP issues Contract Manufacturing Agreements
Speaker Bio John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) for 3½ years. More>>>
Sponsorship During each webinar, a 15-minute break period will be allotted for companies to promote new products and technologies in today's fast paced environment. More>>>
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