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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.

 
   
Live Webinars   Recorded Webinars
No Recorded Webinars found
LHSCDRD001
07/06/2017
10:00 AM PST | 01:00 PM EST,
Duration 60 mins
David R Dills  
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

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....

View Details

$165 
Single Live
(Only for one Participant)
$335 
Multiple Single
( 2 - 5 Participants)
$670 
Corporate Live
( 6 - 10 Participants)
$193 
  Recorded
(6 months unlimited access)
 
LHSCDRD002
07/20/2017
10.00 AM PST | 01.00 PM EST,
Duration 60 mins
David R Dills  
GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

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 anal....

View Details

$165 
Single Live
(Only for one Participant)
$335 
Multiple Single
( 2 - 5 Participants)
$670 
Corporate Live
( 6 - 10 Participants)
$193 
  Recorded
(6 months unlimited access)
 
NO RECORDED WEBINAR FOUND.
 
 
 

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