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.

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Global News

9 October 2024
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Video

2024 ISPE FOYA Category Winner for Innovation: Eli Lilly Kinsale Limited

Internally, this project has been recognized for superior performance with the 2022 Global Lilly IT Award for the project team’s new material tracking system, and the project team was awarded the Lilly Global Safety...

08 October, 2024
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iSpeak Blog

ISPE Releases Updated ISPE GAMP® Good Practice Guide on Validation and Compliance of Computerized Good Clinical Practice (GCP) Systems and Data

The use of digital information in clinical trials has evolved and expanded rapidly in recent years, raising concerns about data integrity, patient safety, and patient privacy

7 October 2024
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Video

2024 ISPE FOYA Category Winner for Operations – Facility Fit: Takeda

Takeda’s beePFS project is a testament to the company’s commitment to innovation, adaptability, and excellence in project execution. By achieving remarkable success within an accelerated timeline, Takeda has demonstrated...
Global Events

Commissioning and Qualification (T40)

17 October, 2024

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Classroom Training

Commissioning and Qualification Training Course

Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management)...

More

GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course

17 October, 2024

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Classroom Training

GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course

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 a subject...

More

Advancing Pharmaceutical Quality (T74)

17 October, 2024

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Classroom Training

Advancing Pharmaceutical Quality (APQ) Quality Management Maturity Training Course

The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry representatives, for industry use, to provide a practical framework that organizations...

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Videos

9 October 2024
|
Video

2024 ISPE FOYA Category Winner for Innovation: Eli Lilly Kinsale Limited

Internally, this project has been recognized for superior performance with the 2022 Global Lilly IT Award for the project team’s new material tracking system, and the project team was awarded the Lilly Global Safety...

7 October 2024
|
Video

2024 ISPE FOYA Category Winner for Operations – Facility Fit: Takeda

Takeda’s beePFS project is a testament to the company’s commitment to innovation, adaptability, and excellence in project execution. By achieving remarkable success within an accelerated timeline, Takeda has demonstrated...

7 October 2024
|
Video

2024 ISPE FOYA Category Winner – Honorable Mention: United Therapeutics Corporation

The facility is designed to be resilient and independent from the electrical grid in times of power outage or emergency. The microgrid allows the facility to operate in "island mode" and use the battery backup system to...

PIC/S in Latin America: Harmonization of cGMP Procedures

Pharmaceutical Engineering Magazine

This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry. It also highlights Latin American regulators’ current perspectives on PIC/S membership to increase awareness and...

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