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Baseline Guides

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

Published: April 2018 Note: Bound version of this guide will be available 4 May 2018 Pages: 244 Table of Contents Special Pricing for Emerging Economies - Learn More The ISPE...

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Submit Your Facility

Has your company recently designed, built or renovated a state-of-the-art pharmaceutical or biotechnology facility that is best in its class? Submit an entry into the 2019 ISPE Facility of the...

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April 03, 2018

Bowtie Analysis and Barrier-Based Risk Management - Part 3

This article was originally published in the January-February 2018 issue...

April 03, 2018

This article was originally published in the January-February 2018 issue of Pharmaceutical Engineering® magazine . Catch up on this series by reading: Bowtie Analysis and Barrier-Based Risk Management – Part...

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March 13, 2018

Bowtie Analysis and Barrier-Based Risk Management - Part 1

This article was originally published in the January-February 2018 issue...

March 13, 2018

This article was originally published in the January-February 2018 issue of Pharmaceutical Engineering® magazine . Read the entire series: Bowtie Analysis and Barrier-Based Risk Management – Part 2 Bowtie Analysis...

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chapter Events

May

10

Affiliate/Chapter

2018 Mid-Atlantic Science & Technology Showcase

2018 Mid-Atlantic Science & Technology Showcase Brought to you by...

May 10, 2018

2018 Mid-Atlantic Science & Technology Showcase Brought to you by ISPE Chesapeake Bay in coordination with BioBuzz The NEW Mid-Atlantic Science & Technology Showcase will be held on May 10th...

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June

04

Conference

2018 ISPE Quality Manufacturing Conference

*/ /*--> */ FDA, MHRA, PMDA, & Industry Leaders Present...

Crystal Gateway Marriott

June 04, 2018

*/ /*--> */ FDA, MHRA, PMDA, & Industry Leaders Present on Data Integrity, Quality Metrics, & New Technologies in Global Manufacturing Environment Considered to be the paramount conference in the...

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June

06

Conference

2018 ISPE Continuous Manufacturing Workshop

2018 ISPE Continuous Manufacturing Workshop Interest in continuous manufacturing of...

Crystal Gateway Marriott

June 06, 2018

2018 ISPE Continuous Manufacturing Workshop Interest in continuous manufacturing of pharmaceuticals has exploded in the past few years, fueled by the recent regulatory approvals of the first few drug products...

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November

04

Conference

2018 ISPE Annual Meeting & Expo

*/ /*--> */ 2018 ISPE Annual Meeting & Expo Hear...

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...

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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 GAMP® 5 provides pragmatic and practical industry guidance to...

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Guidance Documents

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

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

Published: April 2018
Note: Bound version of this guide will be available 4 May 2018
Pages: 244

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

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

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

Table of Contents

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ISPE Blog

When in Rome – Women in Pharma at 2018 Europe Annual Conference

April 19, 2018

Bowtie Analysis and Barrier-Based Risk Management - Part 5

April 17, 2018

Bowtie Analysis and Barrier-Based Risk Management - Part 4

April 10, 2018

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March 2018

IN THIS ISSUE Cover: Reining in Consumption for Sustainable Manufacturing The word “sustainability” is both overused and abused: We hear about sustain...

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Upcoming Issues

Chesapeake Bay Area Chapter

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

Submit Your Facility

Bowtie Analysis and Barrier-Based Risk Management - Part 3

Bowtie Analysis and Barrier-Based Risk Management - Part 1

2018 Mid-Atlantic Science & Technology Showcase

2018 ISPE Quality Manufacturing Conference

2018 ISPE Continuous Manufacturing Workshop

2018 ISPE Annual Meeting & Expo

GAMP 5 Guide: Compliant GxP Computerized Systems

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

When in Rome – Women in Pharma at 2018 Europe Annual Conference

Bowtie Analysis and Barrier-Based Risk Management - Part 5

Bowtie Analysis and Barrier-Based Risk Management - Part 4

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