Two great meetings - one easy, convenient location
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:
Hear what the FDA has been observing during recent inspections and learn from those findings
Ask questions specific to the technical processes and quality systems
Learn more about the importance of having a strong Quality Culture
Become equipped with a proactive, not reactive, approaches to technical development and quality
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:
Improve how an organization manages all phases of the CMO-Owner Company relationship
Aligns approaches with industry best practices
Addresses Every Phase of the product lifecycle – startup, selection, governance and delivery
The ISPE APQ Assess, Aspire, Act and Advance Framework will be complemented with an OPEX Benchmarking and ICH Q10 maturity assessment tool specifically developed for use with the APQ program by the University of St.Gallen, Switzerland. Used in conjunction with the APQ self-assessment tools for...
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
As we enter the new year, this is the perfect time to make the 2021 ISPE Aseptic Conference part of your personal professional development plans. The virtual conference will allow participation from across the globe with no risk to pandemic exposure. The three-day format with shorter sessions will...