Hope is not a strategy for passing your next inspection. Regulatory Compliance Associates® compliance training 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 & inspection 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)
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, Regulatory Compliance Associates® 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 compliance 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
- Environmental Control
- Calibration / Maintenance
- Purchasing Controls and Supplier Management
- Change Control
- Document Control
- Regulatory Submissions 510(k)
- Non-Conforming Product
- Technical Writing
- Adverse Finding and Consequences
- Contributing to a Successful Quality Culture
About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides compliance training 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, 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 Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.