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Effective teams ensure quality & timely project completion
| Marcia van de Boogaard - Senior Consultant |
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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:
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. |
| Robert Buchholz - Senior Consultant |
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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. |
| Lisa Walters - Senior Consultant |
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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:
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. |
| Kristen Quevedo - Associate Consultant / GQA Sales and Marketing |
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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:
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Consultants
Consultants are hired to assist management by providing:
- Direction and focus
- Experience and knowledge gained from previous assignments
- Specialized analytical skills
- Objectivity
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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