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.
Watch the video from Joe Famulare, Chair, ISPE Board of Directors
“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
- Manufacturing and Operational Excellence – investigate practices that improve manufacturing & prevent drug shortages.
- Transformation of Review and Inspection in Quality Oversight – gain insight into FDA’s new focus on “One Quality Voice” through the integration of multiple review and inspection units.
- Frontiers in Manufacturing Science and Quality – explore cutting edge developments and revolutionary approaches in drug product and delivery and their implications on quality.
- Progress in Quality Metrics – understand the impact of developing regulations on company program implementation and investment.
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: firstname.lastname@example.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.
Discounted rates available for groups of 3 or more.