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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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April 23, 2018

Why You Should Care about Continuous Manufacturing

Continuous manufacturing of pharmaceuticals has been an extremely popular topic...

April 23, 2018

Continuous manufacturing of pharmaceuticals has been an extremely popular topic in our field for the past ~ 10 years or so. You see it in heavily academic circles. You see...

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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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Global Events

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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May

07

Manufacturing

Pharmaceutical Technology Transfer Training Course

Technology transfer (TT) includes knowledge transfer, science and risk-based principles...

May 07, 2018

Technology transfer (TT) includes knowledge transfer, science and risk-based principles including ICH Q8, Q9, Q10, Q11 and efficient processes to meet evolving business needs. As the industry continues to experience...

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May

09

GMPs

Manufacturing

ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course

Due to the growing pressures from global competitors, high marketing...

May 09, 2018

Due to the growing pressures from global competitors, high marketing demands, and the requirements of GMP compliance, the bio-pharm industry (brand drugs and generic drug companies) are looking beyond the...

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Most Popular

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...

Event Details

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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...

Event Details

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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

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
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

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

Why You Should Care about Continuous Manufacturing

April 23, 2018

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

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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

Italy Affiliate

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

Why You Should Care about Continuous Manufacturing

Submit Your Facility

Bowtie Analysis and Barrier-Based Risk Management - Part 3

2018 ISPE Quality Manufacturing Conference

2018 ISPE Continuous Manufacturing Workshop

Pharmaceutical Technology Transfer Training Course

ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course

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

Why You Should Care about Continuous Manufacturing

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

Bowtie Analysis and Barrier-Based Risk Management - Part 5