Controlled
Substances Compliance
Overview
- Individual Compliance by Job Function
- Corporate Compliance by Record keeping
- Prologue: General Regulatory Requirements
Analytical
Registrants & Analytical
Labs Under Manufacturing Registrants
- Standards Room Supervisor
- cGMP Auditor · Analyst/ Chemist/
Microbiologist
- Security
- Disposal/ Destruction
|
Researcher Registrants
- Change in Registration: Researcher
to Manufacturer and Impact on Formulation
Scientist
- Schedule I Studies
- Practical Issues: Switching from Researcher
to Manufacturer
Manufacturer Registrants
- Registration
- Security
- Recordkeeping
- Destruction Practices
- Compliance Aspects of Various Positions
- Materials Management/ Shipping & Receiving
- Batch/ Line Operator
- QA/ DEA-Authorized Observer
- cGMP Auditor
|
Corporate & DEA-Specified
Recordkeeping:
- Registrations
- Good Faith Inquiries
- Inventories and Reconciliations
- DEA 222 Forms
- Quotas
- ARCOS Reports
- SOPS & Training
Import/ Export
- Import
- Export
- IND Materials Recordkeeping
DEA Inspections/
Internal Audit Programs
Wrap-up Discussion |
