Generic placeholder image

David R Dills

David R. Dills, Regulatory Affairs & Compliance Consultant is a Keynote Speaker at Compliance Key INC provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 24 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA?s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits. He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, and works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.

 Webinar Id: LHSCDRD002
10:00 AM PT | 01:00 PM ET
 10/30/2017
 Duration 60 mins

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

The session will provide an understanding and overview of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Gain experience and learn more about detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites. The issue of fraud is again a focus within the clinical research industry. Although high-profile cases tend to periodically........


View Details

               $ 179
       Single Attendee
(Only for one Participant)
         $ 363
Multiple Attendee
( 2 - 5 Participants)
          $ 726
Corporate Attendee
( 6 - 10 Participants)
                  $ 237
         Recorded
(6 months unlimited access)
 Webinar Id: LHSCDRD001
 View Anytime
 Duration 60 mins

Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to........

$ 237  Recorded  (6 months unlimited access)

View Details

    
Copyright © 2017 Compliance Key . All Rights Reserved. Back to Top