Marcia has over 32 years of combined QA and QC experience in the Pharmaceutical and Biotechnology industry.  Areas of expertise include:

• Quality System Development
• Nonconformance and CAPA Programs
• Failure Investigation
• Quality Improvement Initiatives
• GXP Auditing
• Inspectional Preparation
• GXP Training
• ISO Development and Training
• Medical Quality Audits
• QA Site Head for Virtual Companies

Marcia’s experience spans both small-scale clinical manufacturing as well as large commercial manufacturing facilities including companies such as Geneva Pharmaceuticals, Somatogen, and Amgen. She has special expertise in assisting organizations to define, establish and execute quality expectations within their facility. She works closely with Operations and Quality organizations to ensure both functional areas work in unity towards a compliant facility while providing sufficient operational flexibility.

Jeanne has over 21 years of experience in the Pharmaceutical and Biotechnology Industry.  She has direct knowledge in the areas of Manufacturing, Quality Control, Quality Assurance and Validation.

Her areas of expertise include:

• Analytical Laboratory (QC and QA)
• Stability
• Data Analysis
• Failure Investigations
• Validation
• Batch Record Development and Review
• Establishment of Specifications, COA and Release Requirements/Records
• Technical Writing and Review
• Regulatory Document Review
• Development and Validation of Controlled Spreadsheets

Jeanne’s experience has ranged from working with small start-up companies, clients with products in clinical trials, to large commercial operations.  She enjoys the challenge of working with companies to come up with solutions that best fit their individual needs and circumstances.  Jeanne is very knowledgeable in data analysis (stability, assay trending, process control) and documentation.

Jeanne holds a Bachelor of Arts in Molecular, Cellular, and Developmental Biology from the University of Colorado and is currently located in the greater New York City area.

Bob is an experienced, quality professional with over 35 years in the Biological, Pharmaceutical, API, Chemical, and QA fields.

From his experience at companies such as Becton Dickinson, Amgen, Somatogen, Parke-Davis and Monsanto, he brings his background of auditing, quality systems, validation, cleanroom operations, aseptic fill/finish, tableting, and API/chemical manufacturing.

Bob’s varied positions in the industry have made him a knowledgeable, thorough, and skilled, quality systems specialist, auditor, project manager, and trainer.

Bob demonstrates the demeanor and integrity required for auditing. He has performed many contract manufacturer, API, raw material, component, laboratory, and Mock FDA audits. He enjoys both domestic and international travel

Maija has over 21 years of clinical and commercial quality control, regulatory compliance and product development experience in the biotechnology industry.  Professional areas of expertise include:

• GMP System development, implementation, auditing and gap analysis
• Batch record review and approval
• Analytical method development, qualification and validation
• Specification development and justification
• Laboratory design and start-up
• Regulatory document review
• Pre-licensing inspection preparation
• Stability program design and maintenance

Maija has extensive commercialization experience and is very knowledgeable regarding current regulatory requirements. She has been a significant contributor to the commercialization of the approved biotechnology products Enbrel® for rheumatoid arthritis and Vectibix® for metastatic colorectal cancer. Her clinical product experience includes monoclonal antibodies, soluble receptors, fusion proteins and small molecules.

Maija holds a B.S. degree in Molecular and Cellular Biology and Biochemistry from Western Washington University and is located in the greater Seattle area.

Ms. Taylor has over twenty-three years of healthcare industry experience in regulatory affairs, product development, quality control, quality assurance, and manufacturing disciplines with an in-depth knowledge of product development requirements for pharmaceuticals, medical devices, and combination products.

David is a quality professional with 20 years of pharmaceutical and biotechnology experience with both startup and established companies.

David’s industry experience has made him proficient at developing and delivering training programs, developing and executing validation protocols, conducting internal and external audits, and evaluating and implementing quality systems.

David is able to balance company goals with customer needs and safety while satisfying organizational values and applicable regulations. He is adept at communicating with a diverse work force.

In addition to his industry experience, Marv has over 22 years experience with the FDA. As an FDA investigator, Marv specialized in cGMP, Quality System Regulation, and PMA inspections of domestic and foreign medical device manufacturers. He routinely conducted PAI and cGMP inspections of pharmaceutical manufacturers.

From an industry perspective, Marv was a Corporate Compliance and QA auditor at Amgen in Thousand Oaks, California for five years. He performed internal audits at Amgen facilities worldwide and audits of contract manufacturers and suppliers.

Marv has created and presented numerous training classes throughout his career.