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 Center’s 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)² 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
ISA’s 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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