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Global News

August 09, 2018

What's Next for Biopharma Manufacturing?

When the human genome was fully mapped in 2003, a...

August 09, 2018

When the human genome was fully mapped in 2003, a futuristic concept of personalized medicine materialized. Medicine based on a person’s unique genetic make-up was not just a holy grail,...

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August 15, 2018

Power of your Personal Brand – ISPE Women in Pharma

We are surrounded by branding every day, influencing how we...

August 15, 2018

We are surrounded by branding every day, influencing how we buy for our food, cars, and drugs. When you buy your medication, do you buy a brand-name or a generic?...

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August 16, 2018

How Will New Products & Therapeutic Innovations Impact Pharma

The Product Development & Product Systems Track at the 2018...

August 16, 2018

The Product Development & Product Systems Track at the 2018 ISPE Annual Meeting & Expo The pharmaceutical industry is coming out with new product and therapeutic innovations at a rapid...

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ISPE International Honor Awards

Each year, ISPE pays tribute to exceptional efforts put forth...

Each year, ISPE pays tribute to exceptional efforts put forth by Volunteers through special recognition as determined by the International Honor Awards Committee. Those recognized include individual Volunteers, Affiliates and

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Global Events

September

07

Training Course

In-Depth Pharma Training

Gain solutions to your company's immediate goals to lower production...

September 07, 2018

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 present exercises that use current...

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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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Most Popular

January 16, 2018

Regulators Adjust to Better Meet Pharma Market Needs

Christine M. V. Moore, PhD, Global Head and Executive Director,...

January 16, 2018

Christine M. V. Moore, PhD, Global Head and Executive Director, Merck & Co., led “Changes in the Regulatory Landscape,” an education session held 31 October during the 2017 ISPE Annual...

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October 15, 2014

2014 International Honor Awards Announced

2014 International Honor Awards were announced during the ISPE Membership...

October 15, 2014

2014 International Honor Awards were announced during the ISPE Membership Luncheon on Tuesday, 14 October to ISPE groups and Members who have contributed remarkable service. The ISPE International Honor Awards...

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June 04, 2015

2015 ISPE Facility of the Year Award for Honorable Mention

Pharmalucence is ISPE’s 2015 Facility of the Year Award Category...

June 04, 2015

Pharmalucence is ISPE’s 2015 Facility of the Year Award Category Winner Honorable Mention their execution and the entrepreneurial spirit demonstrated by the construction of their new aseptic filling facility in...

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April 13, 2017

Reading Roundup: Top Blog Posts from March 2017

It’s time for another edition of the Reading Roundup featuring...

April 13, 2017

It’s time for another edition of the Reading Roundup featuring the top blog posts from March 2017. Start off your weekend by kicking back and catching up on what the...

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Guidance Documents

See More Documents

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

Published: April 2018
Pages: 244

Table of Contents

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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 Vol 7: Risk-Based Manufacture of Pharma Products

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

Table of Contents

Read Full Description

See More Documents

ISPE Blog

How Will New Products & Therapeutic Innovations Impact Pharma

August 16, 2018

Power of your Personal Brand – ISPE Women in Pharma

August 15, 2018

What's Next for Biopharma Manufacturing?

August 09, 2018

View ISPE Blog

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

Italy Affiliate

ISPE International Honor Awards

In-Depth Pharma Training

2018 ISPE Annual Meeting & Expo

GAMP Data Integrity 21 CFR Part 11 Training Course

Facilities Management Training Course

Guidance Documents

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

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 Vol 7: Risk-Based Manufacture of Pharma Products

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

ISPE Blog