GMP Requirements for Records Reports

OVERVIEW

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

WHY SHOULD YOU ATTEND

Attend this webinar so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for your GMP documentation.

AREAS COVERED

• IND and NDA Content and Format for CMC Information
• Vendor Selection and Management for Outsourcing early Manufacturing
• Raw Material Selections and Considerations
• Required SOPs and Documentation

LEARNING OBJECTIVES

Learn the rules and regulations governing GMP Documentation. Also learn about the development and implementation of strategies for GMP documentation.

WHO WILL BENEFIT

• Directors
• Managers
• Supervisors in Regulatory Affairs
• Manufacturing
• Quality Assurance and Clinical Operations

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