Medpoint » Validation

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)

D.J.C.

PECULIAR — Thu, 30 Oct 2008 14:43:41 +0000

ASQ professional with twenty-two years of experience in regulatory compliance, project management and business process improvement. Industry experience in drugs, biologics, medical devices, IVDs, and tissue banking.

Titles Held: Director of QA/RA; Principal; Corporate Director of Quality /Regulatory; QA/RA Specialist; Project Coordinator, Manager of Clinical Services

Proven capability to accomplish results in different countries and varied business functions
Strong FDA applications for Biologics IND Phase O to III; FDA applications for medical devices and IVDs, IDE’s through PMA’s
Experience with Quality programs, Design Control, SOPs, Assessments, Validation and CAPA’s
US, EU, and CE Marking medical devices and diagnostics; EU and ISO quality management audits
Experienced Auditor with QSR, EU, GC; prepared and received accreditation in EU GMP, QSR, ISO 13485, ISO 9001

J.D.C.

PECULIAR — Thu, 30 Oct 2008 14:25:12 +0000

Twenty years of experience in the areas of Medical Device, Pharmaceutical, Electrical Control, Electronics, and Air Compressor industries. Strong engineering experience in both Process and Equipment validation.

Titles Held: Senior Validation Engineer; Project Manager; Principle Engineer; Senior Manufacturing Engineer; Senior Mechanical Engineer

Experience with new product introductions; mechanical designs; line relocation and start-up
Equipment installation, validation protocol creation and execution and operator training
Hands-on experience with high-vacuum/high-temperature equipment, high-pressure hydraulic systems, high-pressure air systems, clean rooms and equipment, and high-volume aqueous washing and solvent washing/degreasing systems
Expert in designing, implementing, and executing FAT, IQ, OQ, PQ, and PV protocols
Experience with Class II and Class III medical 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