Quality Systems
Training
Training services focus on two areas: labeling and promotional materials, and quality assurance and compliance.
Labeling and Promotional Materials Training
- General Training Class: This session covers an overview of FDA; what is a claim; what is promotional labeling at company-controlled vs.-sponsored events; and who is regulated.
- FDA Press Release Review: This session reviews the checklist used by the FDA when reviewing any press materials submitted for preclearance.
- What Can We Do Between Phase II and Phase III?: This session covers the opportunities available to partner with investigators, how to work with the media during this time and website issues.
- Full Prescribing Information (PI) Class: This session covers the roles and responsibilities when writing the PI, European partner’s responsibilities and explains why regulatory does not write the PI.
- How to Prepare for An Advisory Committee Meeting: This session covers general points to consider when preparing for a meeting, what to do during the meeting, and what you need to be prepared for after the meeting
- Considerations for Launch Class: This session covers how to prepare for launch, including FDA strategies and timeline preparation. This training can be split into two sessions, one covering pre-approval launch plans and the second covering post-approval launch plans.
Quality Assurance and Compliance
- General Training Class: This session covers an overview of general current Good Manufacturing Practices regulations; how to prepare for and manage audits and regulatory inspections; and how to prepare for and manage pre-approval inspections.
- Customized Training Classes: Sessions can be tailored to your specific project or needs.
