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FDA Documentation

Conferences and Meetings

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Organizations

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Associations and Industry Groups

American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific society of more than 10,000 members employed in academia, industry, government and other research institutes worldwide. Founded in 1986, AAPS aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development. www.aaps.org

ANSI Online is designed to provide you with convenient access to timely and relevant information on the ANSI Federation and the latest national and international standards- related activities. web.ansi.org

ARMA International is a not-for-profit association   that  provides education, research, and networking opportunities to information professionals, to enable them to use their skills and experience to leverage the value of records, information, and knowledge as corporate assets and as contributors to organizational success. www.arma.org

Audit Repository Centers concept of a global central repository to maintain audit information is based upon PDA's Supplier Audit Process Model. The Process Model establishes a standardized framework for conducting audits of suppliers that provide computer products or services to the regulated industry. ARC is the PDA licensed service provider for the repository www.auditcenter.com

The Biotechnology Industry Organization is a 900 member organization focused on the Biotechnology Industry. www.bio.org

The British Standards Institution is a subscription service formed in 1901 and incorporated under Royal Charter in 1929. As well as facilitating the writing of British standards, BSI is one of the world's leading standards authorities representing UK interests across the full scope of European and international standards committees.
www.bsi-global.com

The Collaborative Electronic Notebook Systems Association (CENSA) is an international industry association, focused on driving the state of the art for electronic record keeping systems and collaborative technologies wherever they are used. For CENSA's  21 CFR Part 11 resource web page or www.censa.org

CESG is the Communications-Electronics Security Group, part of the United Kingdom Civil Service, tasked with looking after the technical aspects of keeping official IT and communications systems safe from compromise. www.cesg.gov.uk

CHPA (Consumer Healthcare Products Association) is the 119 year-old national trade association representing manufacturers of nonprescription, over-the-counter (OTC) medicines and dietary supplements. www.chpa-info.org

The Cosmetic, Toiletry, and Fragrance Association (CFTA), is a trade association for the personal care products industry. Founded in 1894! www.ctfa.org

Drug Discovery & Development Magazine focuses on biotechnology assays, techniques, and people in the postgenomic world. It features new instrumentation and technologies in the field of genomic and proteomic analysis, and genome R&D. www.dddmag.com

The DIA (Drug Information Association) is a non-profit, multi-disciplinary, member-driven scientific association with a membership of over 22,000. These members are primarily from the regulatory agencies, academia, contract service organizations, pharmaceutical, biological and device industries, and from other health care organizations. www.diahome.org

The objectives of the European Biometric Forum are to formally establish The EBF, to draw up a roadmap for the EU Commission which will investigate and advise on the likely commercial application of biometrics over the forthcoming ten years and to carry out clearly focused research into key biometric areas. www.eubiometricforum.com

The European Compliance Academy was founded in Heidelberg, Germany, on 1 January 1999. The objective of ECA is to support the building up of a common platform for discussions between Regulatory Authorities (EU, FDA) and the pharmaceutical industry on cGMP compliance topics. www.gmp-compliance.org

The purpose of the Federal Information and Records Managers (FIRM) Council is to improve the efficiency and effectiveness of information and records managers in the United States government. The FIRM will perform as a central repository from which all agencies can benefit. The FIRM will provide a forum for sharing knowledge, resources, and methodologies for the implementation and evaluation of records management systems and practices. pages.zdnet.com/firmweb/firmcouncil/index.html

The Food and Pharmaceutical Industries Division (FPID) helps you understand the latest technology and software for the CPG and Pharmaceutical Supply Chains. Enhance your personal expertise for product manufacturing and packaging, R&D, and clinical trials.
http://www.isa.org/MSTemplate.cfm?MicrositeID=533&CommitteeID=5225

The GAMP Forum exists to promote the understanding of the regulation and use of computer and control systems within the pharmaceutical manufacturing industry. Whenever possible, GAMP will form relationships with like minded industry associations to create globally harmonized quality standards and will partner with suppliers to identify and share best practices in order to have a positive influence on the quality of computer products used in pharmaceutical operations. www.ispe.org/gamp

Genomics & Proteomics Magazine focuses on biotechnology assays, techniques, and people in the postgenomic world. It features new instrumentation and technologies in the field of genomic and proteomic analysis, and genome R&D. www.genpromag.com

The Graphics Communication Association sponsors many conferences and forums on XML applications and how they impinge on on document and even records management. www.gca.org

GxPJOBS.com has been launched to provide a much-needed one-stop shop for Job Seekers & Job Advertisers in the validation & regulatory compliance sector. It is specifically targeted towards personnel who operate within Good Practice, Quality & FDA Regulations. www.gxpjobs.com

The Information Systems Audit and Control Association & Foundation (ISACA) is a recognized global leader in IT governance, control and assurance. Founded in 1969, ISACA sponsors international conferences, administers the globally respected CISA (Certified Information Systems Auditor) designation earned by more than 24,000 professionals worldwide, and develops globally-applicable Information Systems (IS) Auditing and Control Standards. An affiliated Foundation undertakes the leading-edge research in support of the profession. www.isaca.org

Formed in mid-1989, the International Information Systems Security Certification Consortium or (ISC) was established as a nonprofit corporation to develop a certification program for information systems security practitioners. www.isc2.org

International Society for Cellular Therapy (ISCT) - An international society comprised of researchers, laboratory specialists, and clinicals involved in cellular research, processing, and therapies. www.celltherapy.org

ISPE, the International Society for Pharmaceutical Engineering, is a world-wide, not-for-profit volunteer Society of technical professionals who apply their practical knowledge in the regulated healthcare manufacturing industries. ISPE is committed to advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience. www.ispe.org 

ISAs online batch community helps you understand the underlying principles and applications of batch control, such as process stages, operations, and the actions needed to create a given set of material. The community also addresses batch control procedures and standards (e.g., ISA-88.01).
www.isa.org...

ISPE Carolina Chapter is one of 16 North American Chapters and eight worldwide affiliates of the Society for Pharmaceutical and Medical Device Professionals. The Chapter is one of the Society's largest and most active chapters and was awarded National's prestigious Chapter Excellence Award in 1997 and 1998. www.ispecarolina.org

A special interest group focused on robotics applications in the laboratory, Lab Robotics' membership consists of over 5,500 scientists and engineers. Most of the members are from the pharmaceutical and biotechnology industry with others from the chemical, agriculture, cosmetic, food, and specialty industries. www.lab-robotics.org

Manufacturing Execution Systems Association International (MESA) is the not-for-profit association representing software developers, systems integrators, and consultants in the area of MES. MESA's membership, as well as independent reports from the field, point to sharply rising demand for supply chain manufacturing and MESA. MESA has been working since 1992 to educate the world's manufacturers on the benefits of employing MES by widely disseminating free information, as well as holding educational meetings/industry gatherings, and conducting research and analysis. www.mesa.org

The Medical Device Forum is a place for Medical Device industry professionals to share ideas, discuss current issues, or seek solutions regarding the design, manufacture, or regulation of medical devices. Anyone may read, post or reply to the messages in the Forum www.qsrhelp.com/forum/index.html

The National Food Processors Association (NFPA) represents the food processing industry on scientific and public policy issues involving food safety, nutrition, technical and regulatory matters and consumer affairs. www.nfpa-food.org

The National Information Standards Organization (NISO) develops and promotes technical standards used in a wide variety of information services. NISO is a nonprofit association accredited as a standards developer by the American National Standards Institute, the national clearinghouse for voluntary standards development in the U.S. NISO is a leader in shaping international standards. www.niso.org

OASIS, the Organization for the Advancement of Structured Information Standards, is a non-profit, international consortium that creates interoperable industry specifications based on public standards such as XML and SGML. OASIS members include organizations and individuals who provide, use and specialize in implementing the technologies that make these standards work in practice. www.oasis-open.org

PDA is a non-profit international association of more than 9,500 scientists involved in the development, manufacture, quality control and regulation of pharmaceuticals and related products. The association also provides educational opportunities for government and university sectors that have a vocational interest in pharmaceutical sciences and technology. www.pda.org 

PERI is a not-for-profit organization that has been serving the pharmaceutical industry since 1989. Our entire operations revolve around providing you with the highest quality training available to assist you in your current position, and provide you with educational opportunities to enhance your long-term learning. www.peri.org

PhRMA membership represents approximately 100 U.S. companies that have a primary commitment to pharmaceutical research. These companies are discovering, developing and bringing to market medicines that improve our health and quality of life--as well as reduce the overall cost of health care. www.phrma.org

PTi international, a division of the Institute for International Research, provides technical and regulatory courses for Quality and Compliance-related activities. Using our network of experts and curriculum knowledge for specific job functions, PTi provides training to help pharmaceutical, biotechnology, drug delivery and medical device professionals meet performance goals and sharpen professional skills especially in clinical research, computerized systems, GMPs, QC, QA, and Regulatory Affairs. www.pti-international.com

The Regulatory Affairs Professionals Society (RAPS) is the foremost international professional society representing the healthcare Regulatory Affairs (RA) profession and individual professionals worldwide. The RA profession is vital in the process of developing and introducing safe and effective health products worldwide including medical devices, pharmaceuticals, biologics & biotechnology, cosmetics, veterinary products and nutritional supplements. www.raps.org

The Society of Quality Assurance (SQA) was organized to promote the quality assurance profession through the discussion and exchange of ideas and the promulgation and continued advancement of high professional standards. The members of the SQA are dedicated to promoting the highest quality and integrity in studies under their jurisdiction. www.sqa.org

The Software Division is the community for individuals and organizations seeking quality technologies, concepts and techniques to improve the quality of their software products, processes and services. Opportunities include CSQE (Certified Software Quality Engineer), quarterly newsletters, SQP (Software Quality Professional) Journal, conferences, networking, etc. www.asq-software.org

The System Administration, Networking, and Security Institute (SANS) is a cooperative research and education organization through which more than 96,000 system administrators, security professionals, and network administrators share the lessons they are learning and find solutions for challenges they face. SANS was founded in 1989. www.sans.org

Founded in 1994 by Tim Berners-Lee, the inventor of the Web, W3C develops interoperable technologies (specifications, guidelines, software, and tools) that serve as the technical foundation of the Web. W3C is the birthplace of XML, the home of HTML, and benefits from the participation of international organizations. www.w3.org/

The World Batch Forum is a non-profit, professional organization established in 1994 promoting the exchange of information related to the management, operation and automation of batch process manufacturing. The WBF is an association of end-users, vendors, consultants and academics with a strict, non-commercial agenda. In addition to hosting an annual conference with formal presentation and technical papers, the WBF provides organization, management, and structure to facilitate networking among its members and sharing of knowledge and information related to all aspects of batch processing. www.wbf.org 

 


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