Training programmes are key to keeping up with latest trends

In today's growing pharmaceutical industry, professionals need a resource that will assist them in keeping up to date with the latest trends and regulatory changes. With more than 12 000 members throughout 60 countries ISPE, the leading society for healthcare technology professionals, offers forums and services that enhance member's practical knowledge and allow for professionals to share experiences and work together on projects of interest to the industry.

ISPE's focus on education is unparalleled. In an effort to keep members informed of regulatory changes and industry developments, educational programmes are held throughout the year in Europe, North America, Australia, Brazil, Japan and Singapore. The ISPE European Education Committee and North American Education Committee, composed of global industry leaders, select programme subjects.

In the year 2000 European educational events will include Seminar Programmes in Antwerp, Belgium (3­6 April); Zurich, Switzerland (18­21 September); and Amsterdam, The Netherlands (4­7 December).

Training programmes

ISPE now offers two alternatives for individuals seeking basic training on industry issues through its two new divisions: The Professional Development Programme (PDP) and Good Manufacturing Practice Institute (GMP).

The PDP offers structured learning for technical professionals to expand and enhance their academic knowledge. The programme consists of a series of courses intended to make technical professionals more productive. The courses, which are developed and taught by recognised authorities, are designed for individuals new to the pharmaceutical industry, including both manufacturers and firms which service manufacturers. In addition, PDP courses can be held at organisations at management's convenience.

The GMP Institute helps organisations and individuals successfully coordinate, control and continuously improve performance by integrating the four GMP goals of productivity, quality, health and safety, and regulatory compliance. The Institute provides ongoing competency training by offering a structured curriculum of workshops, on-site training, publications, and on-line interactive training resources.

Through its industry journal, Pharmaceutical Engineering, and newsletter ISPEAK, ISPE works to keep all members informed of industry events and important topics. Pharmaceutical Engineering is recognised as one of the world's top journals covering pharmaceutical technology. Technology articles, regulatory information, industry news, new products and classifieds are regular features found in the Journal.

In 1994, industry leaders came together to develop industry-wide guidance for suppliers that would assist in the management and development of computer systems. Good Automated Manufacturing Practices (GAMP), as the guide has been named, is now in its third edition and continues to be a valuable asset to industry professionals worldwide.

Since 1994, ISPE and the US Food and Drug Administration (FDA) have been working together on a project to develop a series of Pharmaceutical Engineering Baseline guides. The guides provide engineers and other professionals in the pharmaceutical and medical device industries with baseline information on the design, construction and commissioning of new and renovated facilities, equipment, and systems to achieve regulatory acceptance. To date three guides have been completed and are now available from ISPE, and three others are under development. A series of nine guides is planned.

In 1997 ISPE became the first pharmaceutical society to receive US Vice President Al Gore's Hammer Award. ISPE and the FDA received the award for their work in the development of a list of similar equipment needed for efficient implementation of Scale-Up and Post-Approval Change, or SUPAC guidance, for products in immediate release-solid oral dosage form. The guidance and the similar equipment list provide substantive regulatory relief in the filing of change information, bringing savings to the industry.

Upcoming activities for the Society include the formation of national Affiliates in Europe and the Pacific Rim as well as an expansion of influence with other regulatory bodies around the world. In addition, the Society is looking at expanding programming on ISPE's Web Site to better serve the global market.

Enquiry No 34

ISPE Europe is based in Brussels, Belgium.

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