The following information is abstracted from our reprint, The Art of GMP Auditing. This article originally appeared in BioPharm Magazine in June 1997, with permission to reprint given by Advanstar Communications.
Resources for Compliance Professionals (A Partial List)
www.fda.gov FDA's home page is excellent. You may view, download and print current and proposed GMPs, compliance policy guides, the Investigations Operations Manual, recent warning letters and 483 observations, product recall information, and many free guidance or draft guidance documents. The site is easy to use and delineates information for drugs, biologics, and devices. This site is a gold mine for compliance professionals and can help you remain current in your profession.
FDA Office of Small Business Assistance. FDA has an office specially designed to help you achieve voluntary compliance. Regional representatives provide free nonregulatory advice and guidance.
BioPharm magazine runs frequent columns and articles of interest to biologics compliance professionals. Pharmaceutical Technology, BioPharm's sister publication, covers pharmaceutical manufacturing. Both publications are available free to qualified subscribers by contacting Advanstar Communications in Iselin, NJ at (732) 225-9500..
BioProcess International is a new monthly
journal serving the biotechnology industry. BioProcess
International is free to qualified subscribers.
The editorial staff are based in Eugene, Oregon. You may order
the publication at www.bioprocessintl.com.
Medical Device and Diagnostic Industry is a monthly publication covering the device industry. The journal is free to qualified subscribers in the United States, and with a small surcharge (to cover postage) for European subscribers. Contact Canon Communications LLC at web site: www.devicelink.com.
The Pink Sheet, The Gray Sheet, The Gold Sheet, The Silver Sheet. The Pink Sheet is an in-depth weekly newsletter covering the pharmaceutical and biotechnology industry, and The Gray Sheet is an in-depth weekly covering the device industry. The Gold Sheet provides monthly QA/QC information for prescription and over-the-counter products and The Silver Sheet provides monthly information on the quality system rule and design issues affecting the device industry. To subscribe, contact F-D-C Reports at web site www.fdcreports.com.
RAPS, the Regulatory Affairs Professional Society, is well-known for its conferences, educational programs, materials, and publications. You may reach RAPS at web site: www.raps.org.
PDA, an International Association for Pharmaceutical Science and Technology (formerly the Parenteral Drug Association), offers a number of conferences, courses, and meetings for compliance and industry professionals, as well as a newsletter, journal, and technical reports for members. To join PDA, or to ask about upcoming events, contact the PDA in Bethesda, Maryland, at web site: www.pda.org.
Drug Information Association (DIA), sponsors
conferences in the United States and internationally on documentation,
trials, and many other topics. Members receive discounted meeting
registrations, a journal and quarterly newsletter, and a directory of
clinical research organizations
(CROs). To join DIA or obtain a list of their upcoming events,
DIA at their web site, www.diahome.org.
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