NSF’s OTC GMP Program: What is it and how to use it
PrintWebinar
Free webinar
About this course
Time: 10am EST - Duration: 1 hr
Over the Counter drug manufacturers have been cited in recent years for significant compliance failures. A number of companies have managed product recalls and suffered a rapid loss of confidence by both customers and regulators, and it will take these companies years to recover. The FDA 483 observations cited by the Agency cover Quality Systems, Procedures, Specifications and a long list of other weaknesses. The majority of the issues cited by the Agency can be avoided if companies pursue a proactive, forward-thinking strategy of compliance. NSF International has developed a program to help OTC manufacturers identify compliance gaps and develop improvement plans, and provide training to manufacturers of OTC products to help them comply with regulations
What You Will Learn
- OTC manufacturing GMP issues frequently cited by the FDA
- Overview of the NSF Program for OTC manufacturing assessment and improvement
