FDA-Compliant Medical Device Complaint Handling Systems

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Tue, Nov 05, 2013
60 Minutes
Product Description

Know the Applicable Statutes to Efficiently Maintain Medical Device Complaint Handling Systems

It’s vital to effectively set up and maintain medical device complaint handling systems, which is compliant with the applicable FDA regulations.

Since all medical device manufacturers need to comply with complaint handling requirements, it’s essential to comprehend the relevant and applicable requirement for achieving compliance and remaining compliant, which can save enormous amount of time and effort in business, while ensuring the safety and effectiveness of the medical device products.

Join Dr. David Lim, Ph.D., RAC, ASQ-CQA, in this power packed session to know the tips and techniques of implementing medical device complaint handling procedures that will remain compliant. David will also get you familiarized with the FDA-compliant system for handling all types of medical device complaints.

Areas Covered in the Session

  • Understand the applicable statutes and regulations for the medical device complaint handling
  • Definitions
  • Know what to do when  you receive the complaints
  • Find ways of processing complaints
  • What processes need to be in place
  • Identify when to investigate complaints
  • Know when to open a CAPA(s)
  • Find out the investigation and documentation requirements
  • Know the relationship between complaints, risk management, MDR, and CAPA
  • Enforcement actions: case studies
  • Lessons learned
  • Good practices: execution

Who Should Attend? RA, R&D,QA/QC/QS, Compliance officers, Attorneys, CROs, Consultants, Contractors/subcontractors, Senior management, Anyone interested the topic

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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