Chairman’s Chatter: Exciting Things in 2017—Past, Present, and Future

ISPE Foundation

The ISPE International Board of Directors has approved the establishment of an ISPE Foundation. We are currently filing associated legal documents and finalizing the organizational structure for the foundation. We expect these efforts to be complete in the coming weeks.

The objective of the ISPE Foundation is to support education, training, and research for the advancement of innovative technologies and to address global challenges in the development, manufacture, and supply of quality pharmaceutical products for the benefit of patients around the world. It is our aim to leverage this foundation to achieve these goals on a global basis and among other objectives to provide a platform to support our Chapters and Affiliates.

We look forward to meeting with the Chapters and Affiliates leaders at our 2017 Annual Meeting & Expo to discuss opportunities to leverage and promote the foundation. John Bournas, ISPE CEO and President, Tim Howard, CPIP, PE, Vice President of Global Operations, Commissioning Agents, Inc., and I will also be joining the next regional Council teleconferences to provide more details and answer any questions.

Guidance Documents Update

We are thrilled over the success of the ISPE GAMP® Guide: Records and Data Integrity. Published in March 2017, this guide remains in high demand and we continue to receive very positive feedback on the content. View the table of contents for a complete overview of the key takeaways from this guide. If you haven’t already, make sure to get your copy today!

We have two new guidance documents that will be rolling out in July 2017, so keep an eye out for these titles in the next few weeks:

• GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)
• Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) (Second Edition)

And as a reminder, ISPE Members have FREE access to all of ISPE’s concept papers—just another one of many ISPE Member benefits! Make sure to check out two of the most recently published concept papers:

• The Role of Process Capability in Monitoring Product Quality: Monitoring Requirements and Self-Audit Continuous Improvement Opportunities
• Data Privacy: A Compliance Blind Spot

ISPE International Board Meeting at Pfizer  

On 22 August 2017, the ISPE International Board will hold a meeting at Pfizer in Cambridge, Massachusetts USA. The ISPE Boston Chapter Board members will join us the night before the meeting, allowing the opportunity to network with our peers, exchange thoughts on current trending topics, and discuss upcoming events.

2017 ISPE Annual Meeting & Expo 

The 2017 ISPE Annual Meeting & Expowill be here before you know it! This event showcases the latest, successfully employed strategies and technologies that meet today’s growing complexities in the pharmaceutical industry. You’ll have the opportunity to hear from regulators and industry thought leaders from around the world as they address the full spectrum of pharma industry needs through six technical tracks and 80+ education sessions.

This signature ISPE event features an extensive expo hall with more than 200 companies, as well as a variety of networking and social events.

Watch this short video to see exactly what you can expect at this year’s Annual Meeting & Expo.

I hope to see you in San Diego in October!

Thank You to Our Volunteers 

We are just six months into the year and ISPE has already hosted six conferences/workshops and more than 30 training sessions. In addition, we’ve published four guidance documents, two reports/studies, two concept papers, one handbook, and four issues of Pharmaceutical Engineering® magazine. This is a substantial number of technical events and publications for the first half of the year, and we could not have done it without the support of our volunteers.

Myself and the entire ISPE team would like to extend a thank you to all our volunteers for helping us produce such relevant, cutting-edge content for our conferences, training programs, and global documents.

Our volunteers contribute a considerable amount of personal time for the benefit of ISPE and the pharmaceutical industry. We cannot say it enough—Thank You!