GMP Requirements for Records & Reports
from Training DoyensOVERVIEW
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
For more detail please click on this below link:
https://bit.ly/2zmeRzF
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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This event has passed.
August 17, 2018 from 1:00 to 2:30 pmAugust 17, 2018 01:00 to August 17, 2018 02:30 -
26468 E Walker Dr, Aurora, Colorado 80016
26468 East Walker Drive, Aurora, CO -
Contact Training Doyens for more information
18883008494 or [email protected]
Directions are calculated based on the address provided by the event submitter and may not be precise. Please contact the event coordinator for more detailed information.