Chesapeake Bay Area Chapter

Global News

June 18, 2018

Bringing the Outside In – When a Pharma Factory is Needed in the Future Part 3

This article was originally published in the March April issue...

June 18, 2018

This article was originally published in the March April issue of Pharmaceutical Engineering ® magazine . Catch up on this series by reading: Bringing the Outside In – When a...

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GAMP

GAMP Guide: Records & Data Integrity

Published: March 2017 Pages: 152 Table of Contents Special Pricing for Emerging Economies - Learn More The importance of ensuring data integrity is reflected in guidance, citations, and public comments...

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GAMP Good Practice Guides

GAMP Good Practice Guide: Computerized GCP Systems & Data

Published: December 2017 Pages: 128 Table of Contents Special Pricing for Emerging Economies - Learn More The ISPE GAMP ® Good Practice Guide: Validation and Compliance of Computerized GCP Systems...

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GAMP Good Practice Guides

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Published: August 2017 Pages: 168 Table of Contents Special Pricing for Emerging Economies - Learn More The ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) is...

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Global Events

November

04

Conference

2018 ISPE Annual Meeting & Expo

2018 ISPE Annual Meeting & Expo Hear first-hand from attendees...

Philadelphia Marriott Downtown

November 04, 2018

2018 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...

Event Details

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September

13

Commissioning and Qualification

Facilities

Quality Assurance for Facilities Management Training Course

The successful delivery of manufacturing facilities regulated by various authorities,...

September 13, 2018

The successful delivery of manufacturing facilities regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. This interactive classroom course will provide the learner with tools...

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September

17

Cleaning

Validation

Cleaning Validation Principles Training Course

As cleaning technology and detection methodology advance, so do the...

September 17, 2018

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA's risk-based regulatory initiatives focusing...

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June

07

Commissioning and Qualification

Facilities

Commissioning and Qualification Training Course

Through interactive workshops, this course will explain and apply the...

June 07, 2018

Through 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,...

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Most Popular

November

04

Conference

2018 ISPE Annual Meeting & Expo

2018 ISPE Annual Meeting & Expo Hear first-hand from attendees...

Philadelphia Marriott Downtown

November 04, 2018

2018 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...

Event Details

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GAMP

GAMP 5 Guide: Compliant GxP Computerized Systems

Published: February 2008 Pages: 356 Table of Contents Supporting Materials Special Pricing for Emerging Economies - Learn More Ten years after its publication, the ISPE GAMP ® 5 Guide: A...

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September

24

GAMP®

GAMP 5, Annex 11/Part 11 Basic Principles Training Course

This Classroom training course has been updated to include the...

September 24, 2018

This Classroom training course has been updated to include the new revised EU GMP Annex 11 , and an update on 21 CFR Part 11 . This three-day fundamental course...

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March 14, 2018

Speakers Announced for 2018 ISPE Continuous Manufacturing Workshop

ISPE announced the speaker line-up for their 2018 Continuous Manufacturing...

March 14, 2018

ISPE announced the speaker line-up for their 2018 Continuous Manufacturing Workshop, taking place in 6–7 June in Arlington, Virginia USA, in conjunction with their 2018 Pharmaceutical Manufacturing Quality Week.

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Guidance Documents

See More Documents

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

Published: April 2018
Pages: 244

Table of Contents

Read Full Description
GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: Computerized GCP Systems & Data

Published: December 2017
Pages: 128

Read Full Description
GAMP Good Practice Guide: IT Infrastructure Control and Compliance

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Published: August 2017
Pages: 168

Table of Contents

Read Full Description
Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products

Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products

Table of Contents

Read Full Description

See More Documents

ISPE Blog

Bringing the Outside In – When a Pharma Factory is Needed in the Future Part 3

June 18, 2018

GAMP 5: Past, Present & Future

June 13, 2018

How to Learn About the Pharma Industry & Build a Network of Contacts

June 11, 2018

View ISPE Blog

May 2018

IN THIS ISSUE Cover: The Rise of Biopharmaceutical Manufacturing in Asia Biopharmaceuticals are booming in Asia, buoyed by enhanced regulations, an in...

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Upcoming Issues

Chesapeake Bay Area Chapter

Chesapeake Bay Area Chapter

Chesapeake Bay Area Chapter

Bringing the Outside In – When a Pharma Factory is Needed in the Future Part 3

GAMP Guide: Records & Data Integrity

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

2018 ISPE Annual Meeting & Expo

Quality Assurance for Facilities Management Training Course

Cleaning Validation Principles Training Course

Commissioning and Qualification Training Course

2018 ISPE Annual Meeting & Expo

GAMP 5 Guide: Compliant GxP Computerized Systems

GAMP 5, Annex 11/Part 11 Basic Principles Training Course

Speakers Announced for 2018 ISPE Continuous Manufacturing Workshop

Guidance Documents

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

GAMP Good Practice Guide: IT Infrastructure Control and Compliance

Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products

Baseline Guide Volume 7: Risk-Based Manufacture of Pharma Products

ISPE Blog

Bringing the Outside In – When a Pharma Factory is Needed in the Future Part 3

GAMP 5: Past, Present & Future

How to Learn About the Pharma Industry & Build a Network of Contacts

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