How to Ensure FDA Compliance in Developing a Strong Complaints Handling System | Jan. 21, 2014, 2 PM EDT | Lim

How to Ensure FDA Compliance in Developing a Strong Complaints Handling System | Jan. 21, 2014, 2 PM EDT | Lim

September 18th, 2013 // 6:50 pm @

Webinar Overview

The increasing number of recalls of medical devices and drugs has intensified the focus on ensuring their safety and effectiveness. From both regulatory and business liability perspectives, it is crucial for pharmaceuticals and medical device manufacturers to record, track, and report medical devices and drug-related complaints in a systematic manner. Medical device manufacturers find it challenging to uniformly identify and document information on medical devices from internal and external sources. Pharmaceuticals and biotechnology companies on the other hand find it resource intensive to implement pharmacovigilance processes that help in monitoring and proactively assessing drug safety risk across the product lifecycle.

However, it is mandatory for firms to notify the US Food and Drug Administration (FDA) about the complaints received, device malfunctions, and serious injuries or deaths associated with medical devices and drugs. The risk of receiving FDA warning letters, potential loss of reputation, and heavy penalties, mean that pharmaceuticals and biotechnology companies and medical device manufacturers can no longer depend on homegrown systems, stand-alone applications, or manual paper-based systems for handling complaints. A prompt, adequate and effective complaint handling system that can facilitate compliance, reduce product safety risk, streamline workflow processes, and enhance customer satisfaction is the need of the hour.

Join FDA Compliance expert Dr. David Lim, President and Principal of Regulatory Doctor and on this webinar to understand the importance of establishing and maintaining effective medical device and drug-related complaints handling systems, which are compliant with the applicable FDA regulations.

Other key discussion points include:

  • Understanding the US FDA requirements for medical device and drug-related complaint handling systems
  • Best practices for developing and maintaining efficient complaint handling procedures and systems
  • Capturing, processing, archiving adverse events and reaction information for accurate report filing
  • Saving significant time and resources while ensuring the safety and effectiveness of the medical devices and drugs

What You Receive

With your order, we would like to offer you these six items at no added cost:

  • Powerpoint slides to share
  • Downloadable recording or CD
  • Article – 21 CFR Part 11 Enforcement – Where Is FDA Headed? By John Avellanet, Cerulean Associates
  • Article – 10 Ways to Control Compliance Costs – By John  Avellanet, Cerulean Associates
  • Guide – An Executive Guide to Quality by Design – By John Avellanet, Cerulean Associates
  • Newsletter – FDA Digest – By Latest FDA regulatory news, and recent 483 and warning letter analysis – 12 issues only $399.00

About the Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA – President and Principal, Regulatory Doctor

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products. In particular, he provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, he developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. He provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. He leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim is a lecturer for the MS program in regulatory affairs at the Northeastern University.

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