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, October 17, 2008
Registration Deadline: Monday, October 27, 2008
Who Can Benefit: Any biotech, biologic, or biologic device company’s quality, facility, or design team personnel including: - QA/QC Personnel and Management
- Site head or Site manager
- Design Team
- Regulatory Affairs
- Facilities Personnel
- GMP/GLP Compliance
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Speaker: John R. Godshalk, Ex-FDA
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This all-encompassing live web training course will explore the best practices and regulatory expectations for pharmaceutical GMP facility design, with an emphasis on biologic products. Facility design standards and regulatory expectations will be explored and discussed, as well as the strategies for good facility design, including cleanrooms, flows, HVAC standards and more. Participants will gain an understanding of the overarching principles pertaining to biologics facility design that will meet regulatory expectations for both new facilities and retrofitted or renovated facilities. In addition, personnel flows and controls, quality standards, manufacturing operations, equipment and process flows will be explored relative to facility design. Learning Benefits: Gain a better understanding of regulatory expectations for GMP facility design Understand facility design expectations for biologics and biotech products Understand regulatory and quality standards for facility design Understand cleanroom design Learn the best practices for cleanroom design Discover how proper facility design leads to a quality product Understand selected facility design issues required for certain biologic products
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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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