Medpoint » Mock FDA Audits

D.A.L.

PECULIAR — Thu, 30 Oct 2008 14:46:37 +0000

Regulatory and quality systems specialist with twenty-three years of medical device experience. Excellent understanding of FDA, European, and Canadian requirements, 510(K) pre-market notifications, supplier quality management, process and software validation, risk management, project management, and statistical process control.

Titles Held: Quality Assurance Manger; Senior Process Engineer; Manager of Control Laboratory; Process Engineer

Experience Conducting mock FDA inspections and QSR training
Worked for Start Up companies to large medical device firms
Managed quality systems registrations for US and European clients ISO 19385/6, CMDCAS
Management and coordination of recalls and corrections, FDA inspections and related events
Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA)

R.L.W.

PECULIAR — Thu, 30 Oct 2008 14:40:10 +0000

Thirty-three years of experience in the medical device and combination drug/device regulation, manufacturing, quality assurance and R & D arenas. Specialty is working on the pre-meetings and briefings with the FDA.

Titles Held: Corporate Senior Director of RA; Global Director of RA; Director of RA North America; Quality Assurance Manager; Senior Microbiologist

Has extensive experience in interfacing with the FDA, at the district and headquarters levels, as well as with international regulatory authorities
Strong international experience including international product registrations, CE mark approvals and import/export activities
Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees
Has obtained both PMA’s and 510(k)’s, In-Vitro diagnostics, IND, IDE, PLA and NDA approvals.
RAC certified with extensive knowledge with combination drugs devices

D.A.M.

PECULIAR — Thu, 30 Oct 2008 14:00:31 +0000

Seasoned professional with thirteen of years experience in both Domestic and International Regulatory Affairs and Quality Systems. Strong 510(K) submission work and extensive knowledge of implementation of total quality system certifications for the Medical Device industry.

Titles Held: Manager of Quality Assurance and Regulatory Affairs; Senior Quality Engineer; RA Specialist

Expert in Process and Software Validation; Knowledgable QSR Trainer
Extensive experience with FDA Inspections and Quality system Audits
Experience with Class II Intravascular Devices; clinical trials
Experience working RA and QA systems in the US, EU, Asia Pacific and Latin America; CE Marking experience
Certifications: RAC, ASQ, CQA, RAB-Certified Lead Quality Auditor

P.M.N.

PECULIAR — Sat, 25 Oct 2008 15:48:53 +0000

RAC/CQA professional with over twenty-five years experience with Medical Device Regulation in Compliance Management, Regulatory Affairs, Quality Systems and Clinical Affairs. Specializes in creative regulatory strategies to expedite product registrations.

Director of Regulatory Affairs; Corporate Director, RA/QA; Manager of Regulatory Affairs; RA/Clinical Associate

Develop Design Control Systems and Implementation; experienced in working with product development teams to get medical devices to market in a timely manner
Strong experience with Regulatory Compliance Programs, GMP/QSIT Audits, and Gap Analysis
Develop and implement ISO 13485 compliant Quality Systems
Possess extensive knowledge and expertise of FDA device regulations, EU Medical Device Directive (MDD), Notified Body Audits, FDA QSIT inspections, and IRB/IDE submissions
International Submissions: Design Dossier and Technical File Development; Lead CE mark projects
Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees