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4th Annual Quality Manufacturing Conference

ISPE, FDA and PQRI have joined forces once again to offer you the most comprehensive manufacturing quality conference in the industry. Hearing first hand from global regulators will provide you with invaluable insights as your company attempts to navigate the increasingly complex nature of regulatory compliance and quality expectations.

Conference Soundbites

“The FDA’s progress in GMP, program alignment & pharmaceutical operation excellence” will be discussed at the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference.  
     ~ Lawrence Yu, PhD, Deputy Director, FDA/CDER/OPQ

"As the world’s largest healthcare manufacturer, Johnson & Johnson has a long-standing legacy of commitment and partnership with industry associations and Health Authorities to enhance worldwide public health.  Quality is built into our culture and opportunities for collective engagement, such as found at the ISPE/FDA/PQRI Quality Manufacturing Conference, help advance our holistic approach and harness the collective expertise, passion, and compassion from industry, academia, and the government.  It is a tremendous honor for J&J to be invited to contribute to the meeting and by working together we can garner many more comprehensive insights on areas of importance to the health and wellbeing of patients and consumers around the world."
     ~ François Sallans, Vice President and Chief Quality Officer of Johnson & Johnson

"Once again ISPE has assembled an extraordinary group of technical and regulatory experts engaged in deliberation of contemporary issues associated with pharmaceutical quality.  The technical content in this conference reflects the breadth of complexity and variety of solutions that make this industry so dynamic."
     ~ Roger Nosal, PhD, Vice President, Global Chemistry, Manufacturing & Controls (GCMC), Pfizer Inc.

"This year's quality manufacturing conference includes topics that are on everyone's agenda for 2016. Current supply chain challenges, cultivating a continuous improvement culture, innovation, measuring quality, operational excellence, and data integrity."
     ~ Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ 

Key Program Elements

SUBMIT QUESTION for Industry & Regulatory Discussion Forum »

Facility of the Year Reception & Banquet


Join ISPE and prominent industry leaders as we recognize the 2016 Category Winners for their innovation and creativity in pharmaceutical and biotechnology facility design, construction and operation at the Facility of the Year Awards (FOYA) Banquet on the evening of Tuesday, 7 June 2016 in North Bethesda, MD during the ISPE/FDA/PQRI Quality Manufacturing Conference. The FOYA Awards Banquet is the perfect opportunity to be seen by top pharmaceutical decision makers. Register as an individual or bring a group of your colleagues to honor and support these esteemed winners.

Individual tickets may be purchased during registration for $155.00. For information on sponsorships or to purchase a table of 8, contact:

Chris Galione, Director of Global Sales
Telephone: +1-301-364-9212, email: cgalione@ispe.org

Data Integrity Workshop

The FDA has published their latest draft guidance on data integrity, "Data Integrity and Compliance With CGMP Guidance for Industry". The guidance will represent the FDA's current stance on the role of data integrity in current good manufacturing practice (CGMP) for drugs. To gain more insight into this newly published guide and more, attend the ISPE Data Integrity Workshop Sunday, 5 June 2016 in Bethesda, MD.

This workshop is a value add and must-attend event for anyone who wants to receive a comprehensive and in-depth view of key data integrity issues faced over the pharmaceutical product lifecycle. Plus it is a savings of $100 if you register for both the workshop and Quality Manufacturing Conference, which are being held at the same venue.

Learn more about Data Integrity Workshop

Group Discount

Discounted rates available for groups of 3 or more.

Add to your Calendar » Register Now »

Event Sponsors

Handouts and Attendee Roster Available!

Click here for Registered Attendee Only access:

Conference handouts »
Attendee Roster »

Question for Industry and Regulatory Leaders?

Submit your questions for consideration by recognized leaders presenting during the Industry and Regulatory Discussion Forum on Wednesday.

Submit Your Question Now » 

Questions your colleagues are asking:

  • Both CDER and CDRH are working on quality metrics initiatives which similar objectives but with different approaches, what actions are in progress or could be taken to harmonize?
  • What are your thoughts about the benefits and challenges of an industry-led quality metrics program?
  • What evidence does FDA or industry have to justify the requirement that partially stoppered vials need to be transported from a filling line to a lyophilizers under ISO Class 5 air? Is there a basis for this requirement that is rooted in science? It presents challenges in cleanroom design and equipment design.
  • What is your view of the future of Quality Metrics?
  • After years of the QbD development efforts, Do we know if it is worthy of the effort? Does it improve the product quality, reduce the rejection rate, improve the efficiency, etc.? How do we evaluate it?
  • Is there any difference to evaluate the emerging technologies for example Continuous Manufacturing process? Are the current proposed metrics applicable to these emerging technologies? Are there any additional indicators can be used?
  • What is your organization’s practice to monitor the manufacturing process during routine commercial production? What are the commonly used metrics/indicators to help identify the potential problems then guide the team to take proactive steps to prevent potential problems instead of “firefighting”?

Keynote Speakers

Dara Corrigan Headshot

Dara Corrigan, JD

Associate Commissioner for Global Regulatory Policy, FDA/OC/OGROP
View Bio

Lynne Krummen Headshot

Lynne Krummen, PhD

Vice President, Global Head for Biologics, Technical Regulatory and the Global Lead for Quality by Design, Genentech, Inc., A Member of the Roche Group
View Bio

Michael Kopcha Headshot

Michael Kopcha, PhD, RPh

Director, Office of Pharmaceutical Quality Offices and Leadership, FDA
View Bio

Steven Solomon Headshot

Steven Solomon, PhD

Deputy Associate Commissioner for Regulatory Affairs, FDA/ORA
View Bio

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