Hope is not a strategy when it comes to Audit and compliance training for an FDA inspection. 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 Training Checklist FDA Readiness Inspections Mock Inspection / Gap Assessment / Identifying High Risks Leverage Learnings (Internally Across Company) Remediation Subject Matter Expert Training

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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

Inspection Training 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

 

About RCA

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

 

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

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, Health Canada, MHRA and globally-regulated companies.

 

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

 

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

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.