ISPE seminars relate technical documents with education

December 29, 2006 — /ISPE/ — TAMPA, FL — ISPE, a global not-for-profit Society of pharmaceutical manufacturing professionals representing more than 23,000 Members worldwide, is introducing a fresh approach to its world-class Professional Development sessions in 2007. Professional Development seminars will match up new pharmaceutical manufacturing trends with the latest ISPE technical documents at its Tampa Conference, to be held 12-15 February 2007 at the Hyatt Regency Tampa Bay in Tampa, Florida, USA.

Attendees will gain a greater understanding of specific practical applications as a result of this strategic match up. In addition, attendees will have the ability to select half-day sessions, moving from one to another to maximize their investment of time and funds during the conference.

Seminars at the Tampa event will highlight Aseptic Processing, the new ISPE Packaging, Labeling and Warehousing Operations (PACLAW 2007) Guide, Oral Solid Dosages, Sterile Manufacturing Facilities, and much more.

Eight of these sessions will provide direct information related to new ISPE technical documents which will be released in 2007. These documents are reviewed by the US Food and Drug Administration and are best practices for the pharmaceutical manufacturing industry. These include:

ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water Systems, which will be released February 2007;
ISPE Packaging, Labeling and Warehousing Operations (PACLAW) Baseline® Guide;
Bulk Guide Revision;
ISPE Sterile Manufacturing Facilities Baseline Guide;
GAMP® Electronic Data Archiving;
GAMP® Good Practice Guide;
Oral Solid Dosage Baseline Guide; and
Good Engineering Practice Good Practice Guide

Educational sessions include:
Risk Assessment as a Tool of Design, Implementation and Management of Critical Utilities – During this two-day seminar on pharmaceutical waters and steam, topics will include risk-based assessment for microbial testing, parametric release of pharmaceutical waters using on-line instrumentation, the new ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water Systems, and case studies presented by leading pharmaceutical and biotechnology companies and industry experts.

Renovation of Pharmaceutical Facilities: API, Bio Tech, & Pilot Plants – Discuss strategies and decision-making processes for facility renovation, including the feasibility, planning, programming, design and regulatory issues impacting pharmaceutical facility renovations. Case studies on pilot plants, API, and biotechnology will illustrate the significant technical issues surrounding facility renovation, and the maintenance of compliant operations in adjacent facilities.

Aseptic Processing Technology and Guidance for Parenteral Products – Explore new sterilization, aseptic processing, and sterility assurance technologies and processes to shorten a project cycle, increase facility output, and optimize sterile areas. In four consecutive tracks, address recent developments in project execution, facility systems, process equipment, and operational considerations. Walk through design and development options for a sterile/aseptic manufacturing facility and learn the benefits and challenges of current best practices and technologies.

Design and Operation of Biotechnology — Upstream and Downstream Processing – Learn about equipment design and operation in biotechnology facilities, with details on bio-reactors and fermentors as well as harvest and purification unit operations.

GAMP® — Electronic Records: An Update on Part II with a Focus on Risk Management – Get current information on the GAMP approach to risk-based management of electronic records, and take part in workshop activities, and case study discussions that review approaches to e-record management in various domains within the health care industry, and provide insight on the FDA’s current views on the topic.

Oral Solid Dosage Manufacturing Facilities: Case Studies in the Planning, Designing, Engineering and Qualifying of Modern Day Facilities – Several real life case studies from major pharmaceutical firms cover areas of general OSD project considerations, continuous granulation/drying, advanced particle coating, and facility containment upgrade issues. Leading industry OEM’s of processing equipment and systems will present the latest in OSD process technologies and advancements in mixing/blending, granulation, drying, coating, compression, and other key unit operations.

Current Trends and Issues in Validation – This two-day program will present two sessions that focus on current trends and issues in validation. Day one will provide information on current trends in technology focusing on validation. Day two addresses issues and trends that have been implemented for validation.

ISPE Packaging, Labeling and Warehousing operations (PACLAW) Baseline Guide – This seminar will launch the ISPE Packaging, Labeling and Warehousing Operations (PACLAW) Baseline Guide. Guide task team members will present Guide chapters and outline new information; coding, reading and tracking systems in development; and current European and North American regulatory drivers that impact packaging, labeling, and warehousing. Attendees at this session will also receive a copy of the new PACLAW Guide at no charge.

Sterile Manufacturing Facilities — Latest Trends and Case Studies – Walk through design and development considerations for sterile/aseptic manufacturing facilities and learn the benefits and challenges of the latest best practices and technologies, including innovations that will shorten project processes, increase facility output, optimize sterile areas, and involve new technology for improvement of the sterile manufacturing process. Case studies provide real-world examples based on principals of ISPE’s Sterile Manufacturing Facilities Baseline Guide.

In addition to educational sessions, workshops will be held about the new Certified Pharmaceutical Industry ProfessionalTM (CPIPTM) — a new International Credential for Pharmaceutical Industry Professionals. The one hour free workshops feature a CPIP introduction, the latest on eligibility criteria, the application process, and an examination overview. For more information, visit

For complete seminar listings and to register for the conference, visit , or call ISPE customer service at tel: +1-813-960-2105.

Sponsorship and table top exhibition opportunities available for the ISPE Tampa Conference. Please contact Dave Hall, ISPE Director of Sales, by tel: +1-813-960-2105, Ext. 208, or e-mail: [email protected] for details.

About ISPE
ISPE is the Society of choice for more than 23,000 pharmaceutical manufacturing professionals in 81 countries. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Visit for Society news and more information.


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