Hope is not a strategy for passing your next inspection. Regulatory Compliance Associates® Inc. helps your team prepare for and manage inspections, as well as remediate adverse findings. We have a training program that suits your professional needs, company goals, and preferred learning style.

 

Our FDA inspection readiness training and support services include:

 

  • 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 Cross Company)
  • Remediation

 

All of our training programs have been developed as standalone modules, giving our clients the flexibility to deliver a training program that meets its specific needs. We also understand that there will be times when a standard course isn’t the best option. When this is the case, RCA can develop and deliver customized training courses allowing for very specific objectives to be met. This includes the creation of customized workshops and case studies where appropriate. Please contact us to learn more.

 

Our standalone training programs include:

 

  • Good Manufacturing Practice (GMP) Fundamentals
  • Quality System Regulations
  • International Medical Device Regulations
  • Good Documentation Practices
  • Quality Management Systems and Infrastructure
  • Management Responsibility
  • Risk Management
  • Complaints and Medical Device Reportings (MDRs)
  • 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
  • Regulatory Submissions 510(k)
  • Non-Conforming Product
  • Technical Writing
  • Audits
  • Adverse Finding and Consequences
  • Contributing to a Successful Quality Culture

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