This program is closed for pre-registration. Walk-ins will be accepted onsite. If you have any questions, contact us at office@ispeboston.org. 

WHEN:
Thursday, March 27th, 2025
5:30pm-7:30pm

PROGRAM DETAILS:

Join us at Alkermes, 900 Winter St Waltham MA, 02451 on March 27th for an engaging networking event where we’ll connect with industry peers and discuss the complexities of 21 CFR Part 11 compliance when acquiring equipment with integrated computerized systems.

Why This Matters

As regulatory expectations continue to evolve, ensuring compliance with 21 CFR Part 11—which governs electronic records and electronic signatures—is critical for maintaining data integrity and meeting FDA standards. Acquiring new instruments that fall under this regulation requires a proactive approach to avoid compliance pitfalls that can delay instrument qualification and disrupt operations.

The Power of Early Assessment

A key takeaway from this session will be understanding the importance of conducting an early compliance assessment during the purchasing phase. By evaluating vendor certifications, data integrity controls, and Part 11 readiness upfront, organizations can streamline the qualification process, minimize unforeseen challenges, and ensure smoother implementation.

What You’ll Gain

• A clear understanding of 21 CFR Part 11 requirements in equipment acquisition
• Best practices for early compliance assessments to avoid qualification delays

Meeting Fees

To help offset event costs, the following registration fees apply:

• ISPE Members: $25
• ISPE Emerging Leader Members: $15
• ISPE Student Members: $5
• Non-Members: $40 

This event is great for professionals involved in quality, validation, IT, and equipment procurement who want to enhance their approach to regulatory compliance and risk mitigation.

Don’t miss this opportunity to engage with industry peers and experts. We look forward to seeing you there!