Greg Weilersbacher on Change Control for GMP Production Facilities
Many companies limit change control to documentation while handling equipment and facilities in isolation, but that practice can wreak havoc on GMP operations.
Compliance with Mobile Medical Devices Discussed in MedTech Intelligence
Device companies seeking to develop products that include a mobile app must ensure regulatory compliance with product and data safety.
Couch Authors Article on GLPs for Dietary Supplement Contract Labs
Supplement brands that partner with contract labs must ensure they are following good lab practices and other quality assurance programs.
Couch Co-Authors Article in FDLI Update on PMTAs for Deemed Products
In October the FDA Center for Tobacco Products (CTP) held a Public Meeting about Preparing Marketing Applications for Deemed Products. A summary of that meeting was co-prepared by Tara Lin Couch, Ph.D. and published FDLI Update magazine.
Steve Armstrong Interviewed on Marketing Claims
Consumers demand certain qualities—think clean label, zero sugar and non-GMO, for example, and marketing claims can affect the ways that foods and beverages are produced.