The ISPE Canada Affiliate extends from Vancouver to Halifax, with Toronto and Montreal being its main centers, and has almost 400 Members.
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Global News
19 June, 2019Stop Talking about Risk, Get serious about Developing Effective Risk Management Tools
OPINION We need to stop just talking about risk, and get serious...OPINION We need to stop just talking about risk, and get serious about actually developing effective risk management tools The pharmaceutical industry and its regulatory age... View All Blog Posts19 June, 2019
18 June, 2019Day 1 - 2019 ISPE Biopharmaceutical Manufacturing Conference in Pictures
Day one of the 2019 ISPE Biopharmaceutical Manufacturing Conferen...Day one of the 2019 ISPE Biopharmaceutical Manufacturing Conference started off with dynamic plenary sessions with presentations on: Advancing Tomorrow's Medicines - Overcomi... View All Blog Posts18 June, 2019
17 June, 2019Know Before You Go - 2019 ISPE Process Validation Workshop
Conference Essentials Conference Agenda Travel Tips Registratio...Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Thursday, 20 June | 0700–1800 Friday, 21 June | 0700–1600 Attendee Toolbox Attendee... View All Blog Posts17 June, 2019
14 June, 2019Sites and Eats of Boston - 2019 ISPE Biopharmaceutical Manufacturing Conference
Boston, home to Fenway Park and the ever-famous Boston Red Sox, w...Boston, home to Fenway Park and the ever-famous Boston Red Sox, will host the 2019 ISPE Biopharmaceutical Manufacturing Conference. The city is known for its historic signific... View All Blog Posts14 June, 2019 -
Global Events
June18
2019 ISPE Biopharmaceutical Manufacturing Conference
2019 ISPE Biopharmaceutical Manufacturing Conference Biotech 4.0: Innovative Development &...Renaissance Boston Waterfront
June 18, 2019View All Events2019 ISPE Biopharmaceutical Manufacturing Conference Biotech 4.0: Innovative Development & Manufacturing for Transformative Therapies The 2019 ISPE Biopharmaceutical Manufacturing Conference focuses on innovation in production methods and technologies that enable...June202019 ISPE Process Validation Workshop
2019 ISPE Process Validation Workshop Challenges in Bio Process Validation:...Boston Renaissance Waterfront
June 20, 2019View All Events2019 ISPE Process Validation Workshop Challenges in Bio Process Validation: Current and Next Generation The lifecycle approach to process validation has been an expectation since 2011 but the emergence of...October272019 ISPE Annual Meeting & Expo
2019 ISPE Annual Meeting & Expo Modernize. Globalize. Transform. The...Caesars Palace Las Vegas
October 27, 2019View All Events2019 ISPE Annual Meeting & Expo Modernize. Globalize. Transform. The 2019 ISPE Annual Meeting & Expo will focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing across the...July11CleaningFacilitiesCIP System Design, Integration and CIP Chemicals Training Course
This course will provide a fundamental overview of clean-in-place (CIP)...July 11, 2019View All CoursesThis course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residue -
Most Popular
Baseline GuidesBaseline Guide Vol 2: Oral Solid Dosage Forms
The ISPE Baseline Guide: OSD Forms is intended to offer a tool for consistent framework for regulatory interpretation, while still allowing a flexible, innovative, and compliant approach to facility design, construction, commissioning, and qualification. This approach is intended to allow manufacturers to better serve their customers by helping reduce costs and improve product quality.June24GAMP®ValidationGAMP® 5 GxP Process Control Training Course
This GAMP 5 GxP Process Control Training Course describes how...June 24, 2019View All CoursesThis GAMP 5 GxP Process Control Training Course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements.October272019 ISPE Annual Meeting & Expo
2019 ISPE Annual Meeting & Expo Modernize. Globalize. Transform. The...Caesars Palace Las Vegas
October 27, 2019View All Events2019 ISPE Annual Meeting & Expo Modernize. Globalize. Transform. The 2019 ISPE Annual Meeting & Expo will focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing across the...October172019 ISPE Cambridge In-Depth Pharma Training Series
Deep Dive Pharma Training Courses Gain solutions to your company's...October 17, 2019View All EventsDeep Dive Pharma Training Courses Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements. Real World Practice: Courses...
Guidance Documents
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GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
PublishedThe ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them. Additionally, system-specific examples of topics such as segregation of duties and critical validation activities to support data integrity are discussed. -
Good Practice Guide: Process Validation
Good Practice Guide: Process Validation
PublishedThe 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
Good Practice Guide: Technology Transfer 3rd Edition
PublishedTransfer 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. -
Good Practice Guide: Single-Use Technology
Good Practice Guide: Single-Use Technology
PublishedSingle-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.
ISPE Blog
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...
