ISPE Boston Area Chapter

05/29/2026

ISPE Boston loves a good photo booth!

05/27/2026

Final reminder to register for Thursday's webinar!
https://www.ispeboston.org/events/?eventID=1528

05/26/2026

Congratulations and John Miksch for sinking the putt!
⛳️

05/26/2026

No complaints about the weather today!! What a gorgeous day to play golf ⛳️🌞

05/26/2026

So close, yet so far!! Thank you Ryan for participating in our putting contest! ⛳️

05/26/2026

In this engaging and research-informed session, Julie Jungalwala will equip us with the tools to find clarity, reclaim courage, and move forward with intention, even when the path ahead is unclear. Blending insights from adult development theory, behavior change research, and over two decades of leadership work, Julie guides participants to reconnect with what truly matters and lead themselves into the future with purpose.

Participants will learn how to:

• Shift from reactive to proactive in times of uncertainty
• Reclaim personal agency and become architects of their own future
• Access the inner clarity needed to lead others through change
• Apply a repeatable framework for ongoing reinvention and adaptability

Registration and details at: https://www.ispeboston.org/events/?eventID=1526

05/26/2026

Be sure to join us on June 11th for this unique facilitated peer-to-peer discussion, where all attendees will be encouraged to contribute their successes and struggles with CMMS. https://www.ispeboston.org/events/?eventID=1509

05/21/2026

*Strengthen your GAMP knowledge—on your schedule.* ISPE has introduced Microlearning, a new on-demand training format designed to deliver focused, practical content in a flexible, self-paced structure. For a limited time, when you join or renew your ISPE membership, you can choose:

Microlearning: GAMP® Basic Principles – GAMP 5® Overview (a $145 value)
• Covers core GAMP 5® principles aligned to evolving technologies & regulations
• Includes practical frameworks and real-world examples
• Supports a risk-based, science-driven approach to GxP computerized systems

OR receive a $15 Amazon gift card

👉 Use code ISPE26GAMP or ISPEAMZ1526 by Friday, 26 June 2026 at:
https://ispe.org/promotional-offer/boost-your-expertise-or-treat-yourself

05/20/2026

Recent advancements in generative artificial intelligence (GenAI), natural language processing (NLP) and machine learning (ML) enable a shift toward continuous, risk-based compliance oversight. This article from ISPE HQ outlines a structured framework for AI integration across inspection readiness and post-inspection response development and presents a practical case study demonstrating measurable efficiency gains within a small pharmaceutical organization.

Regulatory inspections by the US Food and Drug Administration (US FDA) and other global authorities require pharmaceutical manufacturers to demonstrate sustained compliance with 21 CFR Parts 210/211, ICH Q7, EU GMP Annex 1, and related regulatory frameworks. Traditional inspection readiness models a...

05/19/2026

Boston Scientific said Monday it has invested $1.5 billion to acquire a 34% equity stake in MiRus, a company developing a balloon-expandable transcatheter aortic valve replacement system.

The deal gives Boston Scientific a 34% equity stake in MiRus and an option to acquire its TAVR platform by making additional payments totaling $3 billion.