case study

Risk Management in Product Development and Manufacturing

A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product lifecycle.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Risk Management in Product Development and Manufacturing

Background

RCA wrote comprehensive procedures that were flexible for design changes, line extensions, and OEM manufacturing.

A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product life cycle. FDA had noted issues with risk management among a list of 483 observations. Additionally, standardization of the product development process (PDP) across multiple businesses and global locations was needed.

Result

The new PDP process was implemented and risk management 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)

Approach

Regulatory Compliance Associates® Inc. (RCA) provided subject matter experts in product development and quality system regulations and wrote a portfolio of over ten new procedures and thirty templates. Training was provided to client locations in the US and Europe.

Challenge

RCA was requested to write new PDP procedures that would apply to both drug and device developments. These procedures needed to be comprehensive yet flexible to be useful for design changes, line extensions, and OEM manufacturing.

References

  1. FDA Code of Federal Regulations Title 21, Part 820.30, “Design Controls”, April 1, 2010.
  2. 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.
  3. U.S. Department of Health and Human Services, Food and Drug Administration, “Guidance for Industry: Q9 Quality Risk Management,” June 2006.
  4. International Standards Organization, ISO Standard 14971: Medical devices—Application of risk management to medical devices. 2007.

Background

RCA wrote comprehensive procedures that were flexible for design changes, line extensions, and OEM manufacturing.

A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product life cycle. FDA had noted issues with risk management among a list of 483 observations. Additionally, standardization of the product development process (PDP) across multiple businesses and global locations was needed.

Result

The new PDP process was implemented and risk management 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)

Approach

Regulatory Compliance Associates® Inc. (RCA) provided subject matter experts in product development and quality system regulations and wrote a portfolio of over ten new procedures and thirty templates. Training was provided to client locations in the US and Europe.

Challenge

RCA was requested to write new PDP procedures that would apply to both drug and device developments. These procedures needed to be comprehensive yet flexible to be useful for design changes, line extensions, and OEM manufacturing.

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