GMP Requirements for Records & Reports
OVERVIEW This webinar will review the current regulations, guidancedocuments 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. Good Manufacturing Practices Training 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 ...