March / April 2018

First Quarter Update

Timothy P. Howard, PE

Fellow members, it is my pleasure to provide a short update on some of ISPE's accomplishments, its strategic plan, and ongoing activities.


First, I would like to congratulate the following chapters that have recently or soon will convene their annual vendor exhibit or technology conferences. If you haven’t attended one of these events, I encourage you to do so. Each provides great networking and educational opportunities.

  • 01 February: Delaware Valley Chapter 28th Symposium & Exhibition
  • 15 February: Rocky Mountain Chapter 2018 Vendor Show
  • 02 March: San Francisco/Bay Area Chapter 27th Annual Vendor Night
  • 13 March: CaSA 25th Life Sciences and Technology Conference


Kudos to the Women in Pharma (WiP) Community of Practice (CoP), which continues to generate great interest and momentum. WiP is a forum for women in the pharmaceutical industry designed to foster connection and collaboration to promote career advancement and work-life balance. WiP also provides opportunities for speaking engagements, education sessions, technical presentations, and panel discussions.

Since its inception, WiP has created an online community, organized networking dinners at ISPE Annual Meetings, and led technical sessions at ISPE conferences. Look for opportunities to connect with this CoP through your local chapter, at an upcoming conference, or via the CoP online community portal.


One highlight of our strategic plan is “Driving Efficient Manufacturing Operations.” We are acting on this through the following programs and initiatives:


Training courses offered in the United States and Europe include overviews of biotech processing, facility design, and process validation. Our December 2017 biotech conference in San Francisco was well received; we expect similar success at this year’s conference, 3–5 December in San Francisco. ISPE Europe will also host a biotechnology conference in Lyon, France, 20–21 September.

Business results

Our forums, guidances, and trainings are designed to facilitate meaningful exchanges between members, companies, regulators, suppliers, and other organizations The 2018 Facility of the Future conference began the year on a high note, providing a great mix of lessons learned, disruptive technologies, and innovation. The conference also hosted an extended roundtable discussion and networking focused on driving more efficient operations. The Aseptic Manufacturing Conference, 6–7 March in Reston, Virginia, will focus on robotics, sterility assurance, disposables, upgrading legacy facilities, and a new half-day track on highly potent and toxic products. The conference also continues its tradition of providing great regulator interaction. For more information, visit the conference page on the ISPE website:

Leadership in regulation

Our newly formed Regulatory Steering Committee meets every two weeks to stay abreast of global regulatory topics aligned with ISPE concerns and priorities, and identify those where ISPE can lead and contribute to the dialogue.

Foundational training

In addition to the biotechnology courses mentioned above, we have a robust set of training courses planned. Our subject matter experts also provide custom in-house training. You can see the list of courses available on the Training page:

Guidance Documents portal

Launched in January, this permits free online access to a library of nearly 20 Good Practice Guides; this is another way the ISPE gives you the guidance you need to succeed in our industry.


The ISPE Foundation is becoming a significant asset for our members, affiliates, chapters, and industry. Although much remains to be done, we have officially established the foundation and started fund-raising. Our Board of Directors holds regular meetings, with an extended session planned for the 2018 Europe Annual Conference, 19–21 March in Rome, Italy. While focused on long-term maturity, the foundation’s short-term goals of providing scholarships and education grants are well aligned with ISPE’s founding vision: to perpetuate education in our industry.

That’s my wrap-up of the first quarter of 2018. Looking forward to Q2!