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

I'm Interested in Learning More About RCA

We use cookies in order to give you the best possible experience on our website. By continuing to use this site, you agree to our use of cookies.
Accept