Meet newly confirmed keynote for the 2020 ISPE Aseptic Conference, Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA. His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with the FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, he is leading ORA’s pharmaceutical collaboration efforts [...]
CDER Small Business and Industry Assistance (SBIA) invites you to join this 60-minute webinar where NIH's National Library of Medicine (NLM) discusses their Request for Information (RFI) to obtain feedback on modernizing ClinicalTrials.gov. NLM is asking for your input on how to deliver an improved user experience on an updated platform that will accommodate growth [...]
Founded by NSPE in 1951, EWeek (February 16–22, 2020) is dedicated to ensuring a diverse and well-educated future engineering workforce by increasing understanding of and interest in engineering and technology careers. Today, EWeek is a formal coalition of more than 70 engineering, education, and cultural societies, and more than 50 corporations and government agencies. Dedicated to raising [...]
Medical Device Innovation Consortium/MDIC’s Case for Quality program today released a whitepaper recasting the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The whitepaper summarizes the initial findings and recommendations developed by a joint team from [...]
This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. For [...]
This forum brings together leading global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches, and solutions that will drive innovation and quality for the medicines delivered to patients worldwide. This interactive setting with expert-led regulatory and industry presentations and forums will ensure pharmaceutical industry professionals are well-prepared to develop and apply [...]
This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course [...]
Why Attend 6 extensive education tracks -- Facilities & Equipment, Information Systems, Quality Systems & Regulatory, Innovation Forum, Supply Chain, Operations & Packaging and Process Development & Manufacturing 85+ hours of targeted technical sessions, from industry and regulatory leaders Networking opportunities, including 50+ Plenary and Technical Sessions, Facility of the Year Awards Program, Membership Awards Program, Facility [...]
It is difficult in the day to day whirlwind to properly delegate and get the results that you are looking for. This module will take you through a step by step process for delegating effectively. Learn how to spend your time as a leader more productively and understand “SIMPLE” delegation methods. For more info: https://chambermaster.blob.core.windows.net/userfiles/UserFiles/chambers/1492/File/Updated5.29.19_MFG_LeadershipDevelopmentSeries.pdf
Wherever two or more people come together, there is the possibility of conflict. This module gives participants a six-step process that they can use to modify and resolve conflicts of any size. Participants will also learn crucial conflict resolution skills, including disagreeing diplomatically and using the Agreement Frame. For more info: http://tnchamber.chambermaster.com/events/details/mfg-leadership-development-7-module-series-knoxville-09-24-2019-2453