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

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