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GQA's
Quality Professionals
Effective teams ensure quality & timely
project completion
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Marcia has over
24 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
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.
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Maija has over
16 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
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.
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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.
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Ms. Walters has
over 15 years of experience in quality assurance and compliance for
APIs and pharmaceutical products. She is a Certified Quality
Auditor through the American Society for Quality and a Certified
Lead Auditor through the International Registrar of Certified
Auditors. Her areas of expertise include:
- GMP, GLP, GCP, and ISO 9001:2000
Auditing
- Quality System Development,
Implementation and Gap-Analysis
- SOP and Quality Manual
Preparation
- Nonconformance Investigations and CAPA
Programs
- GMP, GLP and ISO 9001:2000
Training
- Batch Record Review and
Approval
- Validation Protocol/Report Review
(facility, equipment and manufacturing processes)
- Data Auditing
- Compounding Pharmacy audits and quality
system development
Ms. Walters has performed many internal
audits, audits of contract manufacturing and API facilities,
contract testing laboratories, compounding pharmacies, chemical and
component manufacturers both nationally and internationally.
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David Mayorga
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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.
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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.
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Kristen has over
ten years of health care industry experience in Solid Dose
Pharmaceutical Manufacturing and Quality Assurance. Her experience
includes:
- Auditing
- Annual Product Reviews
- SOP and Quality Manual
Preparation
- Nonconformance Investigations and CAPA
Programs
- Product Recalls
- Document Control Organization
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Brianna Information under
construction
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Robert Buchholz |
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Bob is an
experienced quality professional with over thirty years in the
biological, pharmaceutical, API, chemical, and QA fields.
From his experience at companies such as
Amgen, Somatogen, Parke-Davis (now King Pharmaceuticals) and
Monsanto, he brings his background of auditing, quality assurance,
protein purification, fermentation, validation, cleanroom
operations, aseptic fill/finish, tableting, API manufacturing,
technical services, and supervision/management.
Bob's varied positions in the industry have
made him a knowledgeable, skilled, and thorough scientist, quality
assurance specialist, manager, and auditor.
Trained as a Certified Quality Auditor, Bob
demonstrates the demeanor and integrity required for auditing. He
has performed many contract manufacturer, supplier, and internal
audits, and enjoys both domestic and international travel.
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Global
Quality Alliance, LLC - revision 11/2009
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Consultants
Consultants are hired to assist management by
providing:
The consultant brings to each assignment
specific and specialized talent and knowledge.
This specialized knowledge can either supplement existing abilities
or provide additional necessary staff expertise.
Biotechnology
The broad definition of biotechnology is simply the industrial use
of living organisms (or parts of living organisms) to produce
foods, drugs, or other products. The oldest biotechnologies include
fermentation and plant and animal hybridization. The newest
biotechnologies range from protein separation technologies to
genomics and combinational chemistry.
Compounding Pharmacies
Compounding is the creation of a drug product by mixing
ingredients. For hundreds of years this was the exclusive way
pharmacists practiced. However, as professional manufacturing
developed, compounding decreased. Fifty years ago, about 60% of
medications were compounded. Today, only about 1% of new
prescriptions are compounded, but compounding may be undergoing a
resurgence.
State and federal laws permit compounding because it sometimes
provides value to patients. In most hospitals, intravenous
antibiotic solutions, total parenteral nutrition units, and special
pediatric dosages are compounded with products specially
manufactured for these purposes. In community pharmacies,
concentrations, dosage forms or combinations of medications that
are unavailable or not readily available can be manufactured. In a
pinch, compounding can be used to prepare products that are hard to
acquire or are temporarily unavailable from their
manufacturer. Community pharmacy compounding requires a
written prescription specifying that the product be compounded for
the specific patient. It is assumed that the formula will be
written on the prescription so that other pharmacists can provide
refills using the same recipe.
A 1997 FDA Modernization Act states that compounding pharmacies
are not manufacturers and are therefore exempt from standard FDA
regulation on that basis. The act prohibited pharmacists from
advertising or promoting compounded drugs, but in April 2002, the
U.S. Supreme Court ruled that the FDA could not restrict
pharmacists from advertising or promoting products solely because
they were compounded. compounded drugs.
While drug compounding is important and useful for patient care,
problems have occurred that raise legitimate concerns about the
quality and safety of compounded drugs and the oversight of
pharmacies that compound them. However, the extent of problems
related to compounding is unknown. FDA maintains that drug
compounding activities are generally subject to FDA oversight under
its authority to oversee the safety and quality of new drugs, but
the agency generally relies on states to provide the necessary
oversight.
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