Chesapeake Bay Area Chapter

The Chesapeake Bay Area Chapter of ISPE was established in 1994 to meet the needs of the growing pharmaceutical and biotech industries in the area. Today, they continue to support the local industries and provide education, training and networking events to members and non-members alike.

Global News

September 10, 2018

Resource to Address Challenges in Pharma Facilities & Equipment

Facilities and Equipment is a very broad track intended to...

September 10, 2018

Facilities and Equipment is a very broad track intended to challenge those involved in the delivery of pharmaceutical facilities used to support the development, manufacturing, testing, and storage of pharmaceutical...

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September 12, 2018

What are Oligonucleotides?

New terms in the biopharma realm rarely surprise us but...

September 12, 2018

New terms in the biopharma realm rarely surprise us but keeping up with the technology and the means of manufacturing can often be challenging. What I really enjoy about ISPE...

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September 20, 2018

Meet BioMarin Pharmaceuticals, Inc – 2018 FOYA Project Execution Category Winner

BioMarin Pharmaceuticals is the 2018 Facility of the Year ®...

September 20, 2018

BioMarin Pharmaceuticals is the 2018 Facility of the Year ® Project Execution Category Winner for their Project FAITH site in Novato, CA. Projects selected in this category exemplify the application...

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August 29, 2018

Getting on the Six Sigma Path to Quality

2018 ISPE Continuous Manufacturing Workshop Disclaimer: This article contains brief,...

August 29, 2018

2018 ISPE Continuous Manufacturing Workshop Disclaimer: This article contains brief, abridged, and informal synopses of remarks from a US FDA regulator during the 2018 ISPE Continuous Manufacturing Workshop proceedings in...

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chapter Events

September

25

Affiliate/Chapter

Chesapeake Bay Area Golf Tournament

ISPE - CBA Chapter 2018 Golf Tournament Join us for...

ISPE

September 25, 2018

ISPE - CBA Chapter 2018 Golf Tournament Join us for the Annual Golf Tournament at Whiskey Creek Golf Club. Always a fun event with great people on an amazing course!...

Event Details

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Most Popular

December 03, 2015

GAMP: Administrators for Instruments – Your Administrator Part 2

By: Mark Newton, Associate Sr. Consultant - QA, Global Quality...

December 03, 2015

By: Mark Newton, Associate Sr. Consultant - QA, Global Quality Laboratories for Eli Lilly and Company Previously we discussed the importance of selecting the right person as your administrator to...

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September 08, 2017

UGA's Wided Najahi-Missaoui Granted First Women in Pharma Scholarship

Wided Najahi-Missaoui, MS, PharmD Wided Najahi-Missaoui, MS, PharmD, doesn’t know...

September 08, 2017

Wided Najahi-Missaoui, MS, PharmD Wided Najahi-Missaoui, MS, PharmD, doesn’t know the meaning of the word "can't." Since arriving in the United States from Tunisia in 2000, she has earned two...

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January 22, 2015

A Risk Based Approach to Regulated Mobile Applications

According to industry estimates, 50 percent of the more than...

January 22, 2015

According to industry estimates, 50 percent of the more than 3.4 billion smartphone and tablet users will download mobile health applications by 2018. With the development of mobile computing, a...

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January 04, 2017

Continuous Biopharmaceutical Manufacturing: Can It Live up to the Hype?

That is the question. And the team presenting during the...

January 04, 2017

That is the question. And the team presenting during the Continuous Processing session at the 2016 ISPE Biopharmaceutical Manufacturing Conference offered a resounding "yes, but", as an answer. Andre Walker,...

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Guidance Documents

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Japan Affiliate: Pest Control Manual

Japan Affiliate: Pest Control Manual

Publication Date: August 2018
Pages: 180

Table of Contents

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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

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ISPE Blog

Meet BioMarin Pharmaceuticals, Inc – 2018 FOYA Project Execution Category Winner

September 20, 2018

What are Oligonucleotides?

September 12, 2018

Resource to Address Challenges in Pharma Facilities & Equipment

September 10, 2018

View ISPE Blog

September 2018

IN THIS ISSUE Cover: The first revision to Annex 1 in a decade has rebuilt and reorganized the document to align with GMP in Europe. New sections on s...

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Upcoming Issues

Chesapeake Bay Area Chapter

Chesapeake Bay Area Chapter

Chesapeake Bay Area Chapter

Chesapeake Bay Area Golf Tournament

Guidance Documents

Japan Affiliate: Pest Control Manual

Japan Affiliate: Pest Control Manual

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

ISPE Blog

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