Speaker Profile

David R. Dills
Bachelor’s Degree, Environmental Science
Global Regulatory Affairs & Compliance Consultant
David R. Dills, Global Regulatory Affairs & Compliance
Consultant currently provides regulatory affairs, compliance and quality
consultative services for early-stage and established Class I/II/III device, In
Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global
landscape, and also has an accomplished record with more than 25 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, IND, BLA and
NDA submissions, preparing Supplements, Amendments, U.S. Agent, 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.
Mr.
Dills has a strong background in the interpretation and applicability of FDA
regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System
implementation and compliance requirements, GxP training, leads and directs
activities for the registration and approval process and working with Agencies
in Asia Pacific, EU and The Americas, including but not limited to FDA,
European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health
Canada; and defining and executing regulatory compliance, risk mitigation and
remediation strategies in response to inspection findings. Additional
activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and
assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of
management oversight, facilitate and direct efforts for remediation planning
and monitoring, and assessment of the critical sub-systems, records and
document controls; and strives for reduction of regulatory compliance risk for
companies.
Mr.
Dills has authored and published validation, regulatory and compliance-related
articles, commentaries and technical guides, and is an accomplished global
industry presenter. Mr. Dills’ academic degrees include Environmental Science
and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and
associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other
industry working groups.

Surviving an FDA Inspection: Understand the Do's and Don'ts and Ground Rules
Speaker:David R. Dills
Time:
25th May 2017 10:00 AM PDT |
01:00 PM EDT
Duration:75 Minutes
Model : GRC-90127
Thu
25
May 2017

Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues
Speaker:David R. Dills
Time:
18th May 2017 10:00 AM PDT |
01:00 PM EDT
Duration:60 Minutes
Model : GRC-90138
Thu
18
May 2017

Writing and Enforcing Effective SOPs
Speaker:David R. Dills
Time:
19th January 2018 10:00 AM PDT |
01:00 PM EDT
Duration:75 Minutes
Model : GRC-90187
Fri
19
Jan 2018