Medpoint » Warning Letters

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

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

A.A.K.

PECULIAR — Thu, 30 Oct 2008 14:32:32 +0000

Twenty years of experience in the Medical Device and Biotechnology industries developing, implementing and maintaining global regulatory affairs, compliance and quality assurance strategies and systems. Strong background with FDA Quality Systems regulations, including ISO 9000:2000, 13485:2003, CMDCAS, MDD, IVDD and HIPAA requirements.

Titles Held: Director of Regulatory Affairs/Compliance Assurance; Senior RA Specialist; Manager of Quality Assurance; Senior Quality Engineer

ISO certification and surveillance
State licensing and Facility registration
QM & SOP writing; Failure investigations
International experience: Pakistan, Costa Rica, Mexico, EU, Canada, Japan and Australia; CE Marking
Certifications: CQA, RAC, Lead Auditor Certification

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

B.A.K.

PECULIAR — Thu, 30 Oct 2008 14:21:16 +0000

Nineteen years of experience providing advice, facilitation and training on the development, administration, and technical aspects of quality improvement efforts for the Medical Device industry. Assist clients with compliance needs including FDA/ISO audits, needs assessments, creating quality systems and auditing.

Titles Held: VP of Quality and Compliance; Quality Assurance Manager; Plant Manager

Due diligence audits, product complaints, Validation/Design control, CAPA’s
Microbiology/Environmental monitoring; Aseptic processing and calibration
Facilitation and training on the development, administration and technical aspects of quality improvement efforts for all levels/areas of quality
Internal and External Quality-system assessments for compliance to FDA regulatory requirements and ISO and EN standards
Certified Quality Auditor

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