Newsletters > ISPEAK Archives 2001

ISPEAK Archives 2001

ISPEAK archives are Adobe® Acrobat® PDF format and are available to ISPE Members only.

January 2001
Highlights: Highlights: Relationship Management: The Key to Successful Project Execution; An Interview with Brian Sixsmith, The UK Affiliate’s Immediate Past Chairman; Zurich Conference Committee Reports; Activating Partnership between IMP Groups and Clinical Research; GAMP Americas Establishes Steering Committee and SIGs; 2000 Annual Meeting Award Winners and Committee Reports; Global Regulatory News, Including developments in chemistry manufacturing and controls, international regulatory requirements, and the purpose of change control.

March 2001
Highlights: Albany Molecular Research Facility Expansion; An Interview with Gert Moelgaard, ISPE and GMA to Host Program in Germany and US; ISPE Presents Career Center in a New Light; An Introduction to the Commissioning and Qualification Baseline®; Guide; New Document Offers Calibration Management Guidance; GAMP Forum Update; GAMP 4: New Structure, New Material; Global Regulatory News.

May 2001
Highlights: Prions and Creutzfeldt-Jakob Disease; An Interview with Jill Hadley, The Clinical Materials Committee Chairperson; ISPE Makes House-Calls: In-House Training Offers Many Advantages; Global Regulatory News; Winter Conference Committee Reports.

July 2001
Highlights: Integrating 3D Structural Analysis and Piping Design Drastically Reduces Man-hours on Design of Chemical Plant; ISPE Financial Statement; Baseline®; Guides Update; ISPE Member Spotlight: Tom Malone, Co-Chairperson of the Student Development Task Team (SDTT); GAMP Americas Update; GAMP Forum Update; Global Regulatory News; BS7799 - Information Security Management; Copenhagen Conference Committee Reports.

September 2001
Highlights: Computer vs Process Qualification; ISPE Member Spotlight: Dr. Guy Wingate; New Document Offers Guidance on Complying with 21 CFR Part 11; Proposed New Sampling and Acceptance Criteria for Powder Blend Uniformity; Technology Transfer Guide Update; GAMP Guide for Validation of Automated Systems, Version 4; Baseline®; Guides Update; Candidates for the 2001-2002 International Board of Directors; Committee Reports from the ISPE Washington Conference; Global Regulatory News.

November 2001
Highlights: Desiccants: A Powerful Weapon Against Moisture and Humidity for Pharmaceuticals and Nutraceuticals; ISPE Member Spotlight: Jon S. Tomson; Baseline®; Guides Update; GAMP Forum Update; Leading Global Pharmaceutical Markets Through 2005; Global Regulatory News.