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 training and readiness 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 Inspection Training
  • 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

 

About RCA

medical device consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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