Chairman's Chatter - Mike Arnold, ISPE International Board of Directors Chair

It has been a very busy and successful past two months for ISPE!


At the ISPE Nordic Affiliate’s Annual Conference, Henrik Goldschmidt was elected Chairman of the Affiliate’s Board of Directors. Congratulations Henrick! Thanks to outgoing Chair, Anders Widov, for a job well done. The meeting was attended by more than 75 participants who heard presentations on “Industry Challenges in a Global market”, “Our Future Workforce”, “Factory of the Future with Information Technology”, and Fighting a Dragon with Nine Heads (you’ll need to look that one up for yourself-LOL). Congratulations to our Nordic Affiliates on what appears to have been a very exciting meeting!

We kicked off our Young Professionals Task Team. The objective of the Task Team is to look at opportunities for engaging and collaborating more frequently with them, to determine how ISPE can be an integral component to their developing careers and how we might leverage their skills and insights in developing our strategic plan. The team will be led by the following three individuals:

Young Professional: Brody Stara- International YP Chair
Industry: Dr. Michael Ku – Vice President, Global Clinical Supply, Pfizer
Academia: Antonio Moreira – Board Director and Provost, University of Maryland

If you are a Young Professional and want to get involved, please contact Brody Stara at or Ciara Durkin at

The US Food and Drug Administration (FDA) issued their much-anticipated draft guidance on the collection of quality metrics—the revised Submission of Quality Metrics Data Guidance for Industry. Work produced by the ISPE Quality Metrics Team was referenced in FDA’s announcement; an indication of the significance of our pilot data. Well done by the Quality Metrics Team under the current Leadership of Mairead Goetz. Be sure to watch for more updates and scheduled training events on Quality Metrics and Quality Culture.

The first in a series of meetings with the International Board Chair and a subset of volunteer Chapters and Affiliate leaders was held to review draft ISPE 2017 Business Plan deliverables. Great discussion ensued and it was helpful in further developing our deliverables. Thanks to all involved in this discussion.


In early December, we held our inaugural Biopharmaceutical Manufacturing Conference and our Board of Directors meeting in San Francisco, California. The conference was a great success and well attended. Thanks to our San Francisco Chapter for their support and for hosting the wine tasting event where we had the opportunity to meet Chapter members, friends, and guests.

At the Board Meeting we approved the 2017 budget and updates to key documents; Governance Structure, By-Laws and Articles of Incorporation. One of the changes we approved was to allow the Young Professionals International Chair to join Board meetings as an invited guest. Brody Stara, the Young Professional International Chair will represent the Young Professionals at each of our 2017 Board sessions and share updates from the Young Professionals Community. Welcome Brody!

All of this and more was completed in the last two months of the year. Wow!!! Well done to everyone involved.

Happy holidays everyone!

Mike Arnold - ISPE International Board of Directors Chair - Signature






By: Mike Arnold, ISPE International Board of Directors Chair