webinar

Combination Products Webinar

If the FDA’s recent finalizations of Good Manufacturing Practices for Combination Practices has left you uncertain about regulation changes, listen in on our webinar on Combination Products: Lessons Learned on Product Development and Regulatory Submissions.

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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Lessons Learned on Product Development and Regulatory Submissions

The FDA’s recent finalizations of Good Manufacturing Practices for Combination Products may have left you uncertain about changes in regulations. Strategic product development, implementation and execution, as well as the correct submission framework, can greatly increase the successful launch of your Combination Product. Learn more about this topic during this webinar on Combination Products: Lessons Learned on Product Development and Regulatory Submissions.

In this one-hour webinar, you will learn how to:

  • Simplify the requirements and navigate complex regulations
  • Establish product development strategy, and implement and execute development via requirements, V&V testing, and the Design History File (DHF)
  • Prepare an effective regulatory submission to address potential challenges
  • Incorporate lessons learned from challenging case studies

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