Alan P. Schwartz

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Listed in Food, Medical Devices, Pharmaceuticals

Company Name: MDI Consultants, Inc.
Education and Credentials:
EDUCATION: City College of New York, B.S. Biology (1972) Graduate Studies in Regulatory Affairs

CERTIFICATIONS: RAB International Certificate Lead Assessor for ISO9000/ISO13485 FDA HACCP Training Course, July 1997
A recognized international expert in US FDA regulations and quality system implementation. A former US FDA Supervisor of field operations and has been consulting to the FDA regulated industries, medical devices, pharmaceuticals, foods and cosmetics. With over 40 years of regulatory experience. Been involved with various cases of provided expert testimony involving FDA compliance, drug and device failure, as well as regulatory issues. Mr. Schwartz has been an invited speaker on the FDA policy and issues both in the US and internationally. He provides his expertise on the FDA to the medical device industry worldwide with clients in Japan, Korea, China, Taiwan, Germany, Italy, Argentina, Brazil and Canada. He also has a widely read Insight Report on dealing with the FDA, Mr. Schwartz also is an Internationally Certified Lead Assessor for ISO13485 and is on the editorial advisory board of the Institute of Validation Technology.
Set up over 350 Quality System for both QSR/cGMP compliance and/or ISO13485/9000 (ISO13485) certification. Many of these systems are in still in place for over 20 years and have consistently passed FDA inspections.
Audited over 400 medical device/pharmaceutical manufacturers and food companies worldwide for FDA compliance.

Participated in over 210 FDA GMP audits of FDA regulated companies, Medical Devices, Pharmaceuticals, IVD, Bio-Clinical Monitoring, Foods Processors and Blood Banks in the USA and worldwide. Last few inspections were in Feb, 2013 in China and another in Canada. Assisted in the FDA-483 and W/L responses for over 200 FDA audits.

Provided strategic planning, FDA liaison and documentation review. Prepared and/or assisted with over several hundred 510(k)/PMAs.

Trained over 250 companies and 20,000 attendees in the FDA’s Quality System Regulations and Regulatory Requirements, FDA Strategic Planning and Dealing with the FDA Inspections - worldwide.

Trained companies in HACCP and Food Safety requirements. Prepare food HACCP programs for all types of food establishments. Achieved AIB/BRC and ISO22000 certification for food establishments.

Accepted as third party GMP Expert by US FDA for mediating and addressing FDA Warning Letters and Injunctions Compliance.

Certified over 18 Pakistani companies for GMP compliance to US FDA.

Given seminars on FDA regulatory affairs and quality assurance worldwide including Thailand, Brazil, Japan, Taiwan, China (in conjunction with CCPIT/CCUS), Korea, Pakistan, Nicaragua, El Salvador.

Formulated and Signed agreement with CCPIT/CCUS (Chinese Committee for the Promotion of International Trade/Chinese Committee for International Standards) to act as their US FDA consulting group to assist Chinese Companies.

Act as the Official Correspondent/US Agent for more than 250 foreign companies.
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