Conference Wrap Up

A look back at one of the best events of the year

“[The ISPE-FDA CGMP] Conference was innovative and forward-thinking.”

“Speakers were inspiring and enthusiastic!”

“… [A] refreshing view on looking at total cost of making strategic decisions and not just short-term dollar value.”

The second annual ISPE-FDA CGMP Conference was highly successful. An unprecedented number of high-level speakers, including over a dozen officials from FDA and top industry leaders, led discussions and workshops on pharmaceutical quality that helped advance industry thinking on hot topics like quality metrics, quality risk management, leadership’s role in a culture of quality and more.

Thank you to the Program Committee, speakers, attendees, exhibitors and sponsors who helped to make this year’s event such a big success! If you weren’t able to join us in Baltimore this year, here’s a look at what you missed:

Plenary Sessions

“As always, Andy Skibo’s presentation was current and relevant, and his delivery engaging.”

“John [Pinion]’s presentation clearly defined the overall process to successful Quality Management. A great tool and valuable ideas, not only for Quality personnel, but for upper management.”

The plenary sessions at the 2013 ISPE-FDA CGMP Conference featured an all-star line-up of regulators and industry thought leaders presenting on some of the industry’s most pressing concerns:

Jespreet Gill Photo Quality Risk Management
Jaspreet Gill, Vice President, Global Quality and Compliance, Baxter
Andy Skibo Photo Quality Pays for Itself
Andy Skibo, Regional Vice President, Biologics-Supply, MedImmune/AstraZeneca
Gerald Heddell Photo Supply of Medicines to the EU
Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA, UK
Howard Sklamberg Photo Vision for Quality
Howard Sklamberg, J.D., Director, Office of Compliance, FDA
John Pinion Photo Leadership’s Role in a Culture of Quality
John Pinion, Global Head of PT Quality and Compliance, Genentech/F. Hoffman-La Roche Ltd.

Breakout Sessions

“I enjoyed the use of practical application of control strategy, and the link between R&D and manufacturing.”

“… [The] material offered was: 1. Clear and easy to follow 2. Provided solutions to challenges 3. Information I will use in my work.”

The breakout sessions at this year’s conference presented cutting-edge thinking and first-ever industry discussions on a number topics that are front-of-mind for global regulatory agencies and top pharma companies:

  • Basic PAI Readiness Success and Advent of Breakthrough Therapies
    Moderator: Joe Famulare, Genentech
  • Quality Management of CMOs
    Moderators: Mike Arnold, Pfizer and Mike Smedley, FDA
  • Leadership in Pharma Quality Management
    Moderator: Edwin Rivera-Martinez, Sanofi-Aventis
  • Quality Metrics
    Moderators: Cindy Salamon, Bristol-Myers Squibb and Russ Wesdyk, FDA
  • Controlling Pharma Data in the Cloud
    Moderators: Randy Perez, Novartis and Krishna Ghosh, FDA
  • Process Performance and Product Quality Monitoring System
    Moderator: George Millili, Merck
  • Continually Investing in Your Facilities and Equipment
    Moderator: Tim Howard, Commissioning Agents
  • CAPA and Lifecycle QRM
    Moderator: Steve Tyler, AbbVie

Drug Shortage Panel
The Drug Shortage Panel discusses the implications of ISPE’s report data.

Quality Metrics Session
A packed room prepares to discuss Quality Metrics for the industry, led by Cindy Salamon, Bristol-Myers Squibb and Russ Wesdyk, FDA.

Quality Metrics Discussion Group

Panel Discussions and Special Events

“Very informative!”

“In the Breakfast with the Inspectors sessions, we were provided insight on what is on the mind of the inspectors, pre and during inspection.”

The 2013 ISPE-FDA CGMP Conference saw the debut of several ground-breaking ISPE initiatives and opportunities for candid interaction between industry and regulators.

Drug Survey Report Cover

ISPE Drug Shortage Report and Panel

The ISPE Drug Shortage Initiative revealed the results of its global survey to identify the root causes of drug shortages, with presentations by Francois Sallans, Johnson & Johnson and Valerie Jensen , FDA to discuss the results from both industry and regulatory perspectives.

The report’s debut was followed by a panel discussion of the results, led by Joe Famulare and featuring Steve Mahoney (Genentech), Francois Sallans, Valerie Jensen, Zena Kaufman (Hospira) and Sam Venugopal (PriceWaterhouseCoopers).

Breakfast with the Inspectors

Breakfast With the Inspectors

This brand-new session was an attendee favorite, with delegates packing the hall to hear moderator Steve Lynn, FDA, and FDA inspectors Ernie Bizjak and Brooke Higgins give their impressions of the inspection process and recommendations for ensuring a smooth inspection.

Meet the Press Photo

Meet the Press

Meet the Press was a standout of the inaugural 2012 CGMP program, and was a success again in 2013. Moderators Jeff Salkin of Maryland Public Television and Bill Paulson of IPQ magazine posed questions to a panel of regulators and industry experts, including Ilisa Bernstein (FDA), Joe Famulare (Genentech), Rick Friedman (FDA) and Gerald Heddell (MHRA).

Hot Topics Photo

Industry-Led Hot Topic Discussion

In another first-time session, moderator Joe Famulare and panel members Andy Skibo, Carol Bye (Pfizer), Brian Lange (Merck), John Pinion and Jaspreet Gill discussed industry concerns related to Quality Risk Management, PAI Readiness and Advent Breakthrough Therapies, CMOs and Leadership in Pharma Quality Management.

Just for Attendees

“One of the few conferences that was relevant and implementable.”

“Regulatory presence throughout was great!”

Did you miss it?

If you missed out on these ground-breaking discussions on pharmaceutical quality, be sure to join us for the 2013 ISPE Annual Meeting, 3 – 6 November in Washington DC USA, where we will be continuing these and other conversations that are vital to the future of the pharmaceutical industry. And stay connected with ISPE for information our expanded “Pharmaceutical Quality Week” events in June 2014!

Be sure to look for technical articles developed from the conference content in upcoming issues of Pharmaceutical Engineering magazine!

Indicates content available to ISPE members only.

Thank you to our Top Tier Sponsors

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