Audio conference highlights
The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.
This audio conference covers:
- Products covered by the new FDA guidance on CGMP for Phase 1 Investigational Drugs
- Overview of a phased approach to compliance
- Detailed presentation of the guidance document
About the speaker:
Marion Weinreb is president of Marion Weinreb & Associates, Inc. With over 175 associates, MWA provides strategic consulting expertise in quality systems and GXP compliance. MWA focuses on GXP auditing in both non-sterile and sterile drug and device systems, CMC and regulatory affairs, QC and analytical, pre-approval inspection preparation, mock audits, quality systems development and continuous improvement, GXP training, GXP document development, validation, and problem resolution for compliance issues.
Marion has over 33 years of quality assurance experience in the pharmaceutical and medical device industries. Marion provides technical training, both customized and standardized, to thousands of professionals in the pharmaceutical and medical device industries.
Who should attend?
- Clinical Operations Managers/Directors
- Quality Assurance & Quality Control
- Manufacturing Managers/Directors
- Research & Development
- Start-up companies preparing for Phase 1 manufacturing