With increasing complexity of supply chains and the need to rapidly respond to internal and external demands, we must remain committed to using sound science and risk based approaches to ensure control. The 3rd Annual ISPE-FDA CGMP Conference is the go-to source for this critical quality information. No other event drives critical conversations forward like this annual conference. Attendance offers a unique opportunity to interact directly with Industry and FDA representatives to:
FDA and Industry experts will provide attendees with insights needed to ensure quality both day-to-day and strategically, over the product lifecycle. Attendees will return to their companies equipped with the tools and practical solutions for processes in: Knowledge Management, Tech Transfer, Combo Products, Assessing Blend and Content Uniformity, Process Validation, Data Integrity, Drug Shortages and Breakthrough Therapy. A powerful lineup of keynote speakers, including Dr. Janet Woodcock, Director, CDER, FDA, Mary Oates, PhD, VP, Global Quality Operations, Pfizer and David Smith, Executive Vice President, Global Operations and IS, AstraZeneca will add to the robust education offered at this annual conference. Following the CGMP Conference, attendees are invited to stay and join regulators from the FDA, leaders from the biopharmaceutical industry and CMOs at the ISPE’s CMO Executive Workshop. This workshop will address the regulatory and operational challenges from every perspective and will discuss next steps in the evolution of these relationships and the FDA perspective. Now more than ever, the partnership between contract manufacturing, development organizations and FDA must be collaborative to ensure high-quality, safe and effective medicines for patients. Staying for this workshop will:
Join ISPE and those who share a goal and passion for delivering reliable and safe drugs to patients in Baltimore, MD 2-5 June 2014 for these two important conferences. Visit the ISPE website for additional information about attending the 3rd Annual ISPE-FDA CGMP Conference and the CMO Executive Workshop.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...