FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

The key learning objectives are To gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for phase I GMPs. It will help you learn practical applications for implementing phase I manufacturing strategies to meet FDA requirements.

Day 1 will cover the following topics to provide the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products:

• Moving a Product out of R&D
• CMC Requirements for an IND Study
• Good Manufacturing Practices: Basics for Beginners
• Raw Material Management

Day 2 will cover topics discussing requirements for early stage products of different types and for vendor selection and management:

• GMPs for Phase 1 IND products
• GMPs for Combination Products and 505(b)(2) Products
• Process Validation for Early Stage GMP
• Outsourcing Early Stage Manufacturing

• Directors
• Manager
• Supervisors
• Lead workers in Regulatory Affairs Quality Assurance and Quality Control
• Workers who will prepare GMP documents for early phase products
• Workers who will review GMP documents for early phase products
• Regulatory affairs workers who will need to deal with submissions covering early phase products

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-gmp-expectations-phase-i-first-in-man-clinical-trials-iso-9001-2015-qms-cmc-seminar-training-80366SEM-prdsm?channel=sciencedz