Hope is not a strategy when it comes to Audit and compliance training for an FDA inspection. Regulatory Compliance Associates® (RCA) helps your team prepare for inspections, manage inspections, and remediate adverse findings. We have a training program that suits your professional needs, company goals, and preferred learning style.
- Front (inspection) and Back (control) Room Logistics
- Tools and Process Flow Diagramming
- Document Control and Tracking
- Facility Tour Preparation
- Personal Behavior and Coaching
- Pre-Approval Inspection Readiness (PAI Audits)
|
- FDA Training Checklist
- FDA Readiness Inspections
- Mock Inspection / Gap Assessment / Identifying High Risks
- Leverage Learnings (Internally Across Company)
- Remediation
- Subject Matter Expert Training
|
Proper training is required in a regulated environment. Regulatory Compliance Associates has a training program that suits your professional needs, company goals, and preferred learning style. The program includes:
- cGMP Fundamentals (Annual Training Required by Regulations)
- Quality System Regulation
- International Medical Device Regulations
- Good Documentation Practices (GDP)
- Quality Management Systems and Infrastructure
- Management Responsibility
- Risk Management
- Complaints
- Corrective and Preventive Action (CAPA) and Root Causes Analysis
- Design Control
- Validation
|
- Inspection Training
- Environmental Control
- Calibration / Maintenance
- Purchasing Controls and Supplier Management
- Change Control
- Document Control
- Non-Conforming Product
- Technical Writing
- Audits
- Adverse Finding and Consequences
- Criminal Offenses
- Contributing to a Successful Quality Culture
|
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at info@rcainc.com.
