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| David Mayorga - GQA Associate Consultant |
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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. Bilingual:
English/Spanish
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| Maija Sorensen - GQA Associate Consultant |
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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:
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. |
| Marv Appleton - GQA Associate Consultant |
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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. |
| Amy Taylor - GQA Associate Consultant |
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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. |
Validation
Establishing documented
evidence that provides a
high degree of assurance
that a system, method, or
operation does what it is
supposed to do, reliably
and consistently.
Qualification
The action of proving
that any equipment or
process works correctly
and consistently and
produces the expected
results. Qualification is
a part of, but not limited
to, a validation process,
i.e.: installation
qualification (IQ),
operational qualification
(OQ), and performance
qualification (PQ).
21 CFR Part 11
Title 21 CFR Part 11 of the
Code of Federal Regulations
deals with the FDA guidelines
on electronic records and
electronic signatures. Part 11,
as it is commonly called,
defines the criteria under
which electronic records and
electronic signatures are
considered to be trustworthy,
reliable and equivalent to
paper records.
Practically speaking, Part 11
requires drug makers,
medical device manufacturers,
biotech companies, biologics
developers, and other
FDA-regulated industries to
implement controls,
including audits, system
validations, audit trails,
electronic signatures, and
documentation for software
and systems involved in
processing many forms of data
as part of business operations
and product development.
The rule also applies to
submissions made to the FDA
in electronic format
(i.e. a New Drug Application)
but not to paper submissions
by electronic methods
(i.e. faxes).
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| © 2007, 2008 by Global Quality Alliance, LLC. / All rights reserved. | Revised 06/08 | |