Small pharma and medical device companies have the same operational and regulatory requirements as the big guys. Unfortunately, lack of funding and experience often result in gaps that are quickly identified by experienced auditors resulting in submission delays or lost vendor contracts.
Hear from experienced auditors who will share their experience in conducting and responding to GMP and GCP audits.
Quality experts Ed Morris and Panous Boudouvas will help you avoid audit observations based on decades of hands-on experience.
Topics to be covered include:
- Standard Operating Procedures
- Events, Investigations & CAPAs
- Controlled Documents
- Electronic Signatures
- Paper Records
- Data Integrity
- Manual Processes
- Contract Manufacturing
- Contract Research Organizations
- Computer Systems Validation
- Cloud Based Systems
The agenda will include a panel discussion of industry experts.
Who should attend:
- Early stage sponsors who are conducting clinical trials
- CROs, CMOs, Central Labs who are expecting a Vendor Qualification Audit
- Medical Device and Software vendors who are new to the Life Sciences Market
- Company executives who want to understand regulations and industry best practices
15 T.W. Alexander Drive
Research Triangle Park, NC 27709