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Ask an FDA Expert Anything
A Free Recorded Q&A Webinar


Ask an FDA Expert Anything Webinar

The FDA Group's Larry Stevens answers over 20 user-submitted questions covering FDA compliance, quality, and regulatory topics.

This recorded webinar is available on-demand. Submit the form on this page to view the free presentation.

Topics include:

  • ISO 13485:2016
  • FDA guidelines regarding data integrity
  • MDR proactive actions
  • FDA inspection readiness
  • Clinical studies
  • Human failures & risk analysis
  • 510(k) for device modifications and innovations
  • Training employees for compliance
  • FDA audits
  • CAPA
  • Compliance for combination products
  • Regulatory harmonization
  • Post-market clinical follow-up studies
  • The future of QSR & ISO 13485

...and much more.

 


Meet the Expert

Larry Stevens, RAC

Larry Stevens, RAC

Mr. Stevens, RAC, has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers.

Larry is a professional speaker who regularly trains on all aspects of FDA requirements while offering practical, successful solutions to FDA problems.

Larry's specialties include planning, creating and auditing quality systems, creating clinical plans, auditing (GMP, GLP, GCP), compliance/quality remediation, design controls, FDA inspection, SOPs, ISO 13485, validation, quality management, and much more.


Watch the the free Q&A webinar ⤴