Hope is not a strategy when it comes to Inspections. Regulatory Compliance Associates® Inc. 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 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. We have 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
- 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
