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

October 09, 2018

What’s New & Highlights for the 2019 ISPE Aseptic Conference

By the year 2025, every second new biopharmaceutical product will...

October 09, 2018

By the year 2025, every second new biopharmaceutical product will be considered highly potent and/or toxic with the oncology sector driving the growth. Highly potent/toxic products are a new generation...

View Article

View All News

October 11, 2018

Hot Topics & Trends in Pharma Quality Systems & Regulatory Efforts

With less than a month to go, we are now...

October 11, 2018

With less than a month to go, we are now working with our industry and regulatory colleagues to finalize the sessions for the Quality Systems and Regulatory Track for the...

View Article

View All News

October 01, 2018

Member Spotlight – Dave McAlonan

David W. McAlonan, BSChE, MBA Retired Retired Dave McAlonan joined...

October 01, 2018

David W. McAlonan, BSChE, MBA Retired Retired Dave McAlonan joined ISPE in 1988 and recently retired from AbbVie, formerly Abbott Labs. Dave has been a Great Lakes Chapter leader and...

View Article

View All News

September 24, 2018

Regulatory Guidance for Designing an ATMP Manufacturing Facility

Have you tried designing an ATMP manufacturing facility and found...

September 24, 2018

Have you tried designing an ATMP manufacturing facility and found the lack of regulatory guidance challenging and even frustrating. I recently had such an experience. Advanced Therapy Medicinal Products (ATMPs)...

View Article

View All News
chapter Events

November

01

Affiliate/Chapter

How to Get to AMAZING! - Increase Your Emotional & Empathetic Listening

How do you “show up?” Do you want to increase...

MedImmune

November 01, 2018

How do you “show up?” Do you want to increase your awareness of both your own and others’ emotions? The presentation will provide opportunities to increase your emotional intelligence &...

Event Details

View All Events
Most Popular

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...

View Article

View All News

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...

View Article

View All News

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...

View Article

View All News

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...

View Product

Guidance Documents

See More Documents

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

Published: October 2018
Pages: 196
Bound version ships after 26 October 2018

Read Full Description
Japan Affiliate: Pest Control Manual

Japan Affiliate: Pest Control Manual

Publication Date: August 2018
Pages: 180

Table of Contents

Read Full Description
Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

Baseline Guide Vol 3: Sterile Product Manufacturing Facilities

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

See More Documents

ISPE Blog

Hot Topics & Trends in Pharma Quality Systems & Regulatory Efforts

October 11, 2018

What’s New & Highlights for the 2019 ISPE Aseptic Conference

October 09, 2018

Member Spotlight – Dave McAlonan

October 01, 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...

View Current Issue

Upcoming Issues

Chesapeake Bay Area Chapter

Chesapeake Bay Area Chapter

Chesapeake Bay Area Chapter

How to Get to AMAZING! - Increase Your Emotional & Empathetic Listening

GAMP 5 Guide: Compliant GxP Computerized Systems

Guidance Documents

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

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

ISPE Blog

Chapter Sponsors