Medpoint » Product Recalls

D.R.D.

PECULIAR — Thu, 30 Oct 2008 16:27:54 +0000

Nineteen years of direct hands-on experience in Class I/II/III medical devices and In-Vitro diagnostics. Extensive experience in Pharmaceutical and Biologic operations in the areas of regulatory affairs, compliance, validation and quality systems to ensure compliance with FDA and international regulations.

Titles Held: Director of FDA Regulations and Compliance; Corporate Director of Technical and Regulatory Compliance; Corporate Manager of QA/RA; Manager of Quality Engineering

Expertise in executing process validation, remediation, supplier qualification, training, internal/due diligence audits and policy/procedure development
Skilled in Risk Management/Assessment; ISO 9001/13485/14971; MDR/AE/product complaints and CAPA’s
International experience in Japan, EU and Canada regulatory bodies/agencies; also MDD 93/42/EEC and CE Mark and Notified Bodies
Experience with PMA’s, IDE’s, 510(k)’s, NDA’s and e-CTD/CMCs submissions
Knowledge with inspection readiness for manufacturers

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