Marion Weinreb has had over 35 years of experience in pharmaceutical, medical device and
biotech quality systems development and implementation. She provides strategic consulting
expertise in quality systems and cGMP compliance. Marion focuses on GMP and/or QSR auditing
in both non-sterile and sterile drug and device systems, Pre-Approval Inspection preparation, mock
audits, quality systems development and continuous improvement, cGMP training, GMP document
development, and problem resolution for compliance issues. She has worked for small and large
companies and has a successful track record for dealing with complex compliance issues in
Development and Commercial settings.
Marion is the President, MWA, a full service consulting company specializing in GCP, GLP, and
GMP quality systems and regulatory compliance. MWA provides consulting expertise from
development through commercialization for the pharmaceutical, biotechnology, and medical
device industries. MWA is a certified woman-owned business.
Biologics – Biotech/ /Licensed IVD/Tissue/ Vaccines
Medical Devices – Durable/Electronics/Implantable/IVDs/ Software/ Sterile
Pharmaceuticals – Antibiotics/API/Bulk Chemicals/Creams & Ointments/ Non-Sterile Liquids/ Solid
Oral Dosage Form/ Parenterals
Others – Combination Drug/Device and Device/Drug Products
Adverse Event Evaluation, Audits – Certification/Due Diligence/ GLP (Animal )/ GLP (Laboratory)
GMP (Biologic)/ GMP (Pharmaceutical) /Quality System Inspection Technique (QSIT)/ Quality
System Regulation (QSR), Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA, FDA –
483 and Warning Letter Responses/Consent Decree, Risk Management, Quality Assurance, Quality
Control, Quality Management, Quality Systems Development/ Implementation, Regulatory Affairs,
Aseptic Processing, Batch Record Review, Chemistry, Clean Rooms – Design and qualification, CMC
Review, Corrective and Preventive Action (CAPA), Design Controls, Document Controls,
Environmental Monitoring, Failure Investigations, Information Systems, Laboratory Controls,
Lyophilization, Metrology/Calibration, Microbiology, Out-of-Specification (OOS) Investigations,
Packaging and Labeling, Preventive Maintenance, Project Management, Quality Engineering, Risk
Analysis – FMEA/FMECA/FTA/HAACP/, Root Cause Analysis, Software – System Design/
Development Lifecycle/ Development Quality Programs, Stability Programs SOP Development,
Sterile Packaging, Sterilization – Aseptic/ Dry Heat/ ETO/Gamma/Steam, Technical Writing,
Validation Computer Control System/Equipment/Facility/Process/ Retrospective/Software/Utility,
Validation Master Plans
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Clinical Expertise: General – SOPs, drug accountability, device accountability, FDA inspection – 483s
1995 -Present Marion Weinreb & Associates, Inc., Mill Valley, CA
Works with clients in the pharmaceutical, medical device, biologic, and biotechnology industries to
develop quality assurance and regulatory strategies for compliance with FDA regulations by:
Performed over 150 internal and external GMP compliance and FDA mock audits of API,
pharmaceutical and medical device manufacturers on behalf of clients, and assisted in
implementing effective corrective actions based on objectionable observations noted during the
Performed gap analyses on existing processes and identified solutions to recurring quality
problems and operational inefficiencies.
Served as the Quality Assurance unit for several small pharmaceutical and medical device
Worked with Research, Development, and Operations groups to improve the level of cGMP
and GLP compliance within their areas.
Conducted over 75 training sessions in topics like: CGMPs for Phase 1 Manufacturing, QA
Oversight of Vendors, Failure Investigations; CAPA; Device QSRs; Pharmaceutical GMPs;
GMPs for Research and Development; Good Documentation Practices; ICH Q8,9,and 10;
Interacting with FDA; SOP Writing; and Technical Writing.
Assisted in preparing more than 20 pharmaceutical companies and analytical laboratories
for successful FDA Pre-Approval and State Inspections. The preparation included: setting
up a project plan, performing focused audits and data reviews, holding PAI readiness status
meetings, training senior management, training relevant analytical, development, quality
assurance, and operations personnel in how to organize data and records, and training
personnel in how to interact with FDA investigators during a PAI.
1991-1996 Roche Bioscience, (Formerly) Syntex, Inc., Palo Alto, CA
Directed the QA organization in Quality activities related to drug development.
Assisted in Pre-Approval activities for 3 drug products, resulting in NDA approval by FDA.
Coordinated implementation of TQM and assisted in training Development Organization in
Total Quality management techniques.
Worked with Management team to lead organization through transition from Syntex to Roche.
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1991-1993 Syntex, Inc., Palo Alto, CA
Manager, QA Audits
Responsible for managing QA department and activities related to contractor manufacturing
and packaging activities.
Performed compliance audits and assisted in implementation of corrective action.
Qualified new sites for contract manufacturing and packaging.
Responsible for the review and approval of batch records generated by contractors.
Responsible for release of drug product manufactured and packaged by contractors.
1989-1991 Ethicon, Somerville, NJ (a Johnson and Johnson Company)
Manager, Pharmaceutical Quality Assurance
Developed QA program for pharmaceuticals in Phase 1 through 3.
Trained organization in QA management principles related to drug development.
Performed qualification audits for contract manufacturing sites.
1987-1989 Johnson and Johnson Corporate, New Brunswick, NJ
GMP Auditor, Corporate QA
Served as QA resource to J&J affiliates in South and Central America.
Managed resource library of technical information and training programs for J&J companies
Performed compliance audits of Johnson and Johnson sites and contractors located in Central
and South America.
1982-1987 Ethicon, Somerville, NJ (a Johnson and Johnson Company)
Quality Engineer/Senior Quality Engineer
Performed engineering functions related to new device development and commercial devices.
Set-up sampling plans, performed statistical analyses, and reviewed historical data for QA
Served as the primary QA liaison for development of a computerized QA program to capture
and analyze quality data related to inspections.
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1980-1981 Ethicon, Somerville, NJ (a Johnson and Johnson Company)
Performed GLP and GMP audits for Ethicon Research Facility responsible for GLP testing of
1980-1980 Forest Laboratories, Inwood, NY
1977-1980 Byk Gulden, Hillside, NJ
QA Technician, QA Supervisor
Member Parenteral Drug Association (PDA)
AWARDS AND HONORS:
1983: Phi Beta Kappa, Long Island University, Brooklyn, NY
1983 Masters, Pharmaceutical Marketing, Long Island University, Brooklyn, NY
1976 B.A., Biology, Rutgers University, New Brunswick, NJ