Chesapeake Bay Area Chapter

Global News

July 17, 2018

Are You a Leader in Aseptic Processing?

Share Your Innovative Tools, Techniques, and Strategies Preparations for the...

July 17, 2018

Share Your Innovative Tools, Techniques, and Strategies Preparations for the March 2019 ISPE Aseptic Conference in Bethesda, MD, USA are in full swing! Take this opportunity to share your story...

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June 20, 2018

Saying “Yes” to Opportunity – Women in Pharma

Life usually doesn’t turn out the way you expect. Most...

June 20, 2018

Life usually doesn’t turn out the way you expect. Most people, when asked, can identify points in their lives when they made a choice and took a certain path, and...

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July 02, 2018

Surrounding & Controlling Underground Leaks in Pharma Facilities & Equipment Part 1

While most in the pharmaceutical industry understand the need for...

July 02, 2018

While most in the pharmaceutical industry understand the need for double-wall containment piping systems, our field observations indicate that many companies do not.

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July 09, 2018

Surrounding & Controlling Underground Leaks in Pharma Facilities & Equipment Part 2

This article was originally published in the 2018 July/August issue...

July 09, 2018

This article was originally published in the 2018 July/August issue of Pharmaceutical Engineering magazine . Catch up on what you missed by reading: Surrounding & Controlling Underground Leaks in Pharma...

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Global Events

November

04

Conference

2018 ISPE Annual Meeting & Expo

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

Pennsylvania Convention Center

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...

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September

10

GAMP®

GAMP Data Integrity 21 CFR Part 11 Training Course

The importance and amount of data being generated to ensure...

September 10, 2018

The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies...

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September

13

Commissioning and Qualification

Facilities

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.

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Most Popular

November

04

Conference

2018 ISPE Annual Meeting & Expo

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

Pennsylvania Convention Center

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

Right versus Left Brain – Is There a Difference for Pharma Engineers?

July 18, 2018

Are You a Leader in Aseptic Processing?

July 17, 2018

Surrounding & Controlling Underground Leaks in Pharma Facilities & Equipment Part 3

July 16, 2018

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July 2018

IN THIS ISSUE Cover: The Fourth Industrial Revolution Technology is advancing faster than ever. Rapid, major changes are on the horizon for just about...

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Upcoming Issues

Chesapeake Bay Area Chapter

Chesapeake Bay Area Chapter

Chesapeake Bay Area Chapter

2018 ISPE Annual Meeting & Expo

GAMP Data Integrity 21 CFR Part 11 Training Course

Facilities Management Training Course

Cleaning Validation Principles Training Course

2018 ISPE Annual Meeting & Expo

GAMP 5 Guide: Compliant GxP Computerized Systems

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

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

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