Medical Device Single Audit Program (MDSAP) - Preparing For A Successful Transition
ISPE San Diego Chapter Presents Medical Device Single Audit Program...
Genesis Campus Point
June 11, 2019
ISPE San Diego Chapter Presents Medical Device Single Audit Program (MDSAP) Preparing For A Successful Transition Sponsored By: Hosted By: Synopsis: On Tuesday, June 11th, the ISPE San Diego Chapter...
A Perspective from the Owner's Representative, Land Developer, Broker and...
Center for Novel Therapeutics
May 23, 2019
A Perspective from the Owner's Representative, Land Developer, Broker and Workplace Culture Expert Thursday, May 23, 2019 4:00 - 7:30pm Program Managers: Deborah Neatherlin, Sr. Account Executive - Life Sciences,...
Good Practice Guide: Applied Risk Management for C&Q
Published: October 2011 Pages: 140 Table of Contents Special Pricing for Emerging Economies The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification describes how organizations can move...
This second edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends to further reinforce the concepts described in the first edition of the Guide, provide examples of how these concepts can be put into practice, and detail the value and benefits of the approach described.
The shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices. The science and risk-based approach combines product development knowledge with a structured process performance and product quality monitoring system to provide for validation throughout the product lifecycle.
Good Practice Guide: Technology Transfer 3rd Edition
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated.
Single-use technology has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly reducing the risk of contamination in manufacturing equipment. The implementation of single-use technology into a process requires a well-defined plan that minimizes surprises during the later stages of implementation.
GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated organization.
In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process...