Medpoint » Pharmaceutical

S.A.G.

PECULIAR — Thu, 30 Oct 2008 17:07:35 +0000

Six Sigma Green belt professional experienced in Quality, Compliance and Regulatory for the Medical Device, Biologics, Pharmaceutical and Combination Products industries. Expertise in preparation and evaluation of Regulatory, Compliance and New Product Development Systems.

Titles Held: World-wide Manager Strategic Quality Combination Products; Quality Manager; Senior Quality Systems Consultant; Director of Regulatory/Quality Systems/Clinical Affairs; Regulatory Coordinator

Strong Regulatory background in regards to warning letters, recalls, protocol writing, 510(k), PMAs, IDEs, PLAs/ELAs
Skilled in Quality systems development and deployment; New product development process from R&D to Launch
International experience working in EU, Canada, Puerto Rico and Mexico; CE Marking and device certification
ASQ Auditor proficient in Supplier/Contract manufacturer audits
Experienced Trainer in the areas of GMPs, cGMPs, GLPs, GCPs, QSRs, ISO 9000, 13485, Design Controls, Internal Auditor and Combination Products

J.A.H.

PECULIAR — Thu, 30 Oct 2008 17:02:31 +0000

Twenty years of regulatory affairs experience in Medical Devices, Pharmaceuticals and
In-Vitro diagnostics. RAC professional with the ability to efficiently organize and streamline regulatory documentation and procedures.

Titles Held: Regulatory Affairs Manager; Product Standard Release Manager; Quality Control/Technical Service Manager; Director of Technical Services; Clinical Laboratory Supervisor

Proven track record of successful negotiations and strong working relations with FDA (CDRH) for new product introductions and regulatory compliance issues
Experience with regulatory strategy, reporting, CAPA processes, recalls and field corrections
Highly skilled at preparing 510(k)’s and Technical Files for CE marking and liaison with Notified Body
Knowledge of reviewing and approving product labeling, advertising and promotional materials, specifications, research protocols and reports
Qualified at managing complaint handling systems and investigating all safety-related incidents

L.S.D.

PECULIAR — Thu, 30 Oct 2008 17:00:37 +0000

Thirty years experience in the Pharmaceutical and high-tech Medical Device industry. Extensive knowledge of Product Development, R&D, Program Management, Quality Systems and Compliance, and Regulatory submissions.

Titles Held: Senior Vice President, Chief Scientific Officer; Principal; Senior VP Scientific Affairs; Executive Director RA/QA and Clinical Affairs; Manager, RA/QA; Senior Design Engineer

Strong validation experience in product and process validation requirements in various countries and management of the design, implementation, and documentation of validation programs for numerous (100+) products around the world
Experience with warning letters and consent decree situations with both domestic and international firms
Successfully designed, developed, and certified clean room facilities in several countries and for a wide range of products
Qualified in conducting clinical trials for IDEs and PMAs as well as clinical evaluations for market penetration purposes
Experience with all device classes:lasers (Surgical and Ophthalmic), to implants (Orthopedic and Ophthalmic), to a wide range of electronic products, disposables, IVDs, and biologics (homologous bone grafts)

V.A.O.

PECULIAR — Thu, 30 Oct 2008 16:56:20 +0000

Twenty year CQA professional with experience in both Quality Systems and Regulatory Affairs. Excellent Audit, Validation, Compliance and Design Control background in the Medical Device and Pharmaceutical industries.

Titles Held: Senior Consultant; Director of Quality Assurance; Project Manager

Excellent international experience: Created several Technical Files and Design Dossiers for the EU, packages for licensing on 6 continents including Canadian License and obtaining Japanese shonin.
Submittal experience with INDs, IDEs, 510Ks, 510Ks with clinical, PMAs, 1 BLA, 1 HDE, CBE-30s and pre-approval supplements (PAS) for CMC changes to approved products
QA Validation: Heavy Design Control background; QA review of Testing Protocols and Final Test Reports to assure compliance with applicable standards and regulations
Strong audit experience with both Internal and External Audits; OEM’s, manufacturers; clinical study sites; sterilization facilities to name a few
Exceptional Technical Writing skills as well knowledge of Regulations and Guidelines: cGMP, cGCP/ICH, cGLP, QSR, ISO 13485:2003, MDD (all Annexes), HIPAA, 21 CFR Part 11, HACCP, Canadian Regulations, ANSI/AAMI

T.A.L.

PECULIAR — Thu, 30 Oct 2008 16:54:21 +0000

Computer System Validation expert with twenty-five years experience in the Medical Device and Pharmaceutical regulated environment. Provide definitive compliance technical expertise for Manufacturing; Quality software, hardware and instrument related projects including acting as Subject Matter Expert on 21CFR Part 11.

Titles Held: Senior Validation Consultant; Senior Validation Engineer; Validation Lead; Senior Project Engineer/Validation Engineer; Principal Engineer; Plant Engineer

Full Validation Life Cycle experience including developing and maintaining Computer System VMPs, Validation Plans, Validation Scripts, and preparing Validation Reports
Start-ups to remediation projects for pharmaceutical, biotech and medical device companies; experienced in new product launches, FDA 483 Warning Letter Remediation and Consent Decree compliance
Expert in IQ/OQ/PQ, FDA Compliance, cGMPs Audits, Complaint Reporting Systems, Bar-Code Systems, Vision Systems, PLCs, SOPs, SCADA systems and server-based systems
Experienced in conducting compliance audits including vendor audits
Demonstrated success in interviewing organizations to gather understanding of needs and requirements

G.J.P.

PECULIAR — Thu, 30 Oct 2008 16:40:55 +0000

Thirty years of increasing responsibility assuring compliance in the regulated medical device and pharmaceutical industries. Strong Regulatory submission work and implementation knowledge.

Titles Held: Director of Regulatory Compliance and Quality Systems; Manager of Quality Assurance; Manager of RA/QA; Manager of Quality Control

Successful submission of four 510(k)’s in a five-month period for Class II devices and one special
Strong knowledge of auditing practices, regulatory and business requirements including ISO 9001, GMP’s, and international regulations
Successfully led three organizations through the implementation process and certification process for ISO certification; led multiple organizations to certification for EN 46001:1996, ISO 13485 and EN ISO 9001
Skilled in all aspects of a regulatory and quality management system for multiple manufacturing sites including design control
Managed Quality System in multiple sites in the US and Puerto Rico

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

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