Hear from two of the guide contributors, Gordon Leichter, PhD, Belimed Life Sciences and Jason Collins, AIA, IPS, on what you will take-away from purchasing this guide including practical and regulatory guidance...
Guide contributor (co-lead) Robert Beall, PMP, ProPharma Group, shares why process validation is an essential part of the pharma industry and how you’ll benefit from the ISPE Good Practice Guide: Practical Implementation...
ISPE announced the release of their latest guide, ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation . This guide provides professional insights for fundamental principles, process lifecycle approaches...
ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Technology Transfer 3rd Edition . This Guide provides industry good practices for successful and efficient execution of technology transfer projects. “Transfer of...
ISPE announced the release of their latest Guide, ISPE Good Practice Guide: Single-Use Technology . This Guide provides a roadmap for efficient implementation of single-use technology (SUT) with minimum disruptions to existing operations. " Single...
ISPE announced the release of their latest Guide, ISPE GAMP ® RDI Good Practice Guide: Data Integrity – Key Concepts . This publication provides detailed practical guidance to support data integrity within a regulated organization. "In recent years...
ISPE announced the release of their latest Guide, ISPE Baseline ® Guide: Sterile Product Manufacturing Facilities (Third Edition) . This publication provides guidance on engineering facets of designing new sterile products manufacturing facilities...
ISPE announced the launch of their new online Guidance Documents Portal . For the first time, the entire library of Guides—including GAMP ® 5—can be accessed and searched online. In addition, the Society has made access to select ISPE Good Practice...
Announcing the release of our latest guidance document, ISPE GAMP ® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) . This guide provides guidance on meeting regulatory expectations for compliant IT (Information...
ISPE announced the release of their latest guidance document, ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition) . This guide provides a scientific, risk-based approach (based on ICH Q9 Quality Risk Management)...
