Connecting Pharmaceutical Knowledge
-
Feature
September 10, 2018Facilities and Equipment is a very broad track intended to...September 10, 2018View All NewsFacilities and Equipment is a very broad track intended to challenge those involved in the delivery of pharmaceutical facilities used to support the development, manufacturing, testing, and storage of pharmaceutical...September 12, 2018New terms in the biopharma realm rarely surprise us but...September 12, 2018View All NewsNew terms in the biopharma realm rarely surprise us but keeping up with the technology and the means of manufacturing can often be challenging. What I really enjoy about ISPE...September 20, 2018BioMarin Pharmaceuticals is the 2018 Facility of the Year ®...September 20, 2018View All NewsBioMarin Pharmaceuticals is the 2018 Facility of the Year ® Project Execution Category Winner for their Project FAITH site in Novato, CA. Projects selected in this category exemplify the application...September 24, 2018Have you tried designing an ATMP manufacturing facility and found...September 24, 2018View All NewsHave you tried designing an ATMP manufacturing facility and found the lack of regulatory guidance challenging and even frustrating. I recently had such an experience. Advanced Therapy Medicinal Products (ATMPs)...
-
Calendar Of Events
November04
2018 ISPE Annual Meeting & Expo
2018 ISPE Annual Meeting & Expo Hear first-hand from attendees...Philadelphia Convention Center
November 04, 2018View All Events2018 ISPE Annual Meeting & Expo Hear first-hand from attendees on why the ISPE Annual Meeting & Expo is the must-attend pharmaceutical event of the year. The 2018 ISPE Annual...October01FacilitiesGMP Sterile Pharmaceutical Manufacturing Facility Training Course
This classroom course uses the second edition of the ISPE...October 01, 2018View All CoursesThis classroom course uses the second edition of the ISPE Baseline ® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing...October01FacilitiesHVACHVAC cGMP Regulations Training Course
This classroom course focuses on common issues and problems in...October 01, 2018View All CoursesThis classroom course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction...October03Commissioning and QualificationFacilitiesCommissioning and Qualification Training Course
Through interactive workshops, this course will explain and apply the...October 03, 2018View All CoursesThrough interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9,... -
Most Popular
August 29, 20182018 ISPE Continuous Manufacturing Workshop Disclaimer: This article contains brief,...August 29, 2018View All News2018 ISPE Continuous Manufacturing Workshop Disclaimer: This article contains brief, abridged, and informal synopses of remarks from a US FDA regulator during the 2018 ISPE Continuous Manufacturing Workshop proceedings in...August 27, 2018If you want to prepare yourself for the next 10...August 27, 2018View All NewsIf you want to prepare yourself for the next 10 years of your career, then I invite you to join me at this year's 2018 ISPE Biopharmaceutical Manufacturing Conference ,...August 24, 2018Shire is the 2018 FOYA Facility Integration Category Winner for...August 24, 2018View All NewsShire is the 2018 FOYA Facility Integration Category Winner for their Los Angeles Master Plan Building 8 Project in Los Angeles, California. Winners in this category exemplify the application of...December 03, 2015By: Mark Newton, Associate Sr. Consultant - QA, Global Quality...December 03, 2015View All NewsBy: Mark Newton, Associate Sr. Consultant - QA, Global Quality Laboratories for Eli Lilly and Company Previously we discussed the importance of selecting the right person as your administrator to...
Guidance Documents
-
Japan Affiliate: Pest Control Manual
Japan Affiliate: Pest Control Manual
Publication Date: August 2018
Pages: 180 -
Baseline Guide Vol 3: Sterile Product Manufacturing Facilities
Baseline Guide Vol 3: Sterile Product Manufacturing Facilities
Published: April 2018
Pages: 244 -
GAMP Good Practice Guide: Computerized GCP Systems & Data
GAMP Good Practice Guide: Computerized GCP Systems & Data
Published: December 2017
Pages: 128 -
GAMP Good Practice Guide: IT Infrastructure Control and Compliance
GAMP Good Practice Guide: IT Infrastructure Control and Compliance
Published: August 2017
Pages: 168
Expand Your Professional Network
2018 ISPE Annual Meeting & Expo
More than 1,500 pharmaceutical professionals from around the world will gather at the ISPE 2018 Annual Meeting & Expo - and you should be there too!
Pharmaceutical Engineering Magazine
September 2018
IN THIS ISSUE Cover: The first revision to Annex 1 in a decade has rebuilt and reorganized the document to align with GMP in Europe. New sections on s...
Not a Member Yet?
Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges.
Pinnacle Program Global Sponsor
