21 CFR Part 11 refers to the section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Chapter 21 covers all regulations pertaining to GCP (Good Clinical Practice), GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice), relating to the pharmaceutical and healthcare industries. Part 11 covers all FDA regulated issues pertaining to electronic records and electronic signatures. All computer systems that store…

Counterfeit goods cost the economy up to $250 billion a year, with U.S. Customs and Border Protection agents seizing nearly $80 million in counterfeit pharmaceuticals and personal care products in one year alone. The World Health Organization (WHO) reports that 200,000 people die each year due to ineffective and substandard (counterfeit) malaria drugs. The WHO also reports similar issues in the medical device market. In 2010, over 8% of devices in circulation were counterfeit and that number increased by 50%…

Biological research is limited by a technical barrier that exists between scientists and lab hardware. Each piece of hardware has its own software, its own file format and its own eccentricities, which the user needs intimate familiarity with to get the most from the machine. Using Antha, a user-friendly but hugely powerful software platform, gives biologists sophisticated, flexible and integrated control over lab hardware. This enables experiments and lab workflows to be rapidly automated, with data automatically integrated and linked…

Gain specialist knowledge in bioprocessing With our Fast Trak education, you can access application training in specialized bioprocessing techniques. The courses provide a tangible learning experience for process development and manufacturing scientists, relevant to everyday work. Comprehensive training for your specific needs The Fast Trak courses cover various topics from upstream to downstream. These include cell culture, bioreactor scale-up, column packing, basic chromatography, as well as optimization and scale-up for both pilot and manufacturing scales. In addition to our standard…

This online module focuses on an intensive overview of the antibody therapeutics field, enabling you to: Gain a comprehensive understanding of the antibody field and awareness of the historical aspects, current research and future direction of the development of antibodies as therapeutics. Provide an overview of the antibody fields ranging from structure and function, through to the recent development of antibodies as therapeutics including manufacture and clinical development. Gain insights to some of the issues that are required to develop…

Now is the time to plan professional development for 2018: check out the Biomanufacturing Education and Training Center’s 2018 schedule. Download the flyer and gain access to exclusive discount opportunities for BPI subscribers. About: The Biomanufacturing Education and Training Center at Worcester Polytechnic Institute (BETC) is where biotechnology professionals gain a competitive edge. Our innovative partnership between academia and industry creates customized workforce development solutions for forward-thinking biotechnology companies across the region and around the world. Whether you’re an employee…

While the popularity of single-use systems (SUS) is increasing, regulation of SUS supply chains is not. With increased regulatory scrutiny on supply chain security and risk mitigation strategies throughout the development and manufacturing of a therapeutic drug product, end users are scrambling to find ways to ensure the expected level of compliance. The solution? Sharing responsibilities across the entire supply chain. Validation must begin at the component raw material level and continue to final assembly. Primary parties – including drug…