Share Our Information
Key Risk Indicators in Product Development & Manufacturing
Background
A global manufacturer of pharmaceutical and medical devices needed to better integrate key risk indicators throughout the product lifecycle. FDA had noted issues with risk management among a list of FDA 483 observations. Additionally, standardization of the product development process (PDP) across multiple businesses and global locations was needed.
RCA wrote comprehensive procedures that were flexible for design changes, line extensions, and OEM manufacturing.
Challenge
RCA was requested to write new PDP procedures that would apply to both drug and device developments. These risks analysis procedures needed to be comprehensive yet flexible to be useful for design changes, line extensions, and OEM manufacturing.
Approach
Regulatory Compliance Associates® Inc. (RCA) provided medical device consultants who were experts in product development and quality system regulations. After identifying key risk indicators, the risk management framework included a portfolio of over ten new procedures and thirty templates. Operational risk & financial risk training was provided to client locations in the US and Europe.
Result
The new PDP process was implemented and risk control was integrated in the following ways:
- Risk Management Planning is a part of Design & Development Planning
- Risk Analysis is an input to Verification and Validation test planning
- Risk Analysis via Process FMEA is required for OEM business
- Risk Reports and Risk Benefit Analysis are inputs to Final Design Review
- Risk Analysis and Reports reviewed periodically based on internally generated data and data received from customers (i.e., complaints)
About RCA
Regulatory Compliance Associates® (RCA) provides worldwide 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.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Regional offices in Florida, Colorado and Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
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.
References
- FDA Code of Federal Regulations Title 21, Part 820.30, “Design Controls”, April 1, 2010.
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, “Design Control Guidance for Medical Device Manufacturers,” March 11, 1997.
- U.S. Department of Health and Human Services, Food and Drug Administration, “Guidance for Industry: Q9 Quality Risk Management,” June 2006.
- International Standards Organization, ISO Standard 14971: Medical devices—Application of risk management to medical devices. 2007.
