The GMPs dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters to the industry for a failure to comply with even the basic tenants of the regulation. In light of this, EAS Consulting Group, leaders in regulatory consulting services and educational seminars, hosted an online exclusive GMP Compliance Short Course. The two-part course covers the basics of working in a GMP environment including personal hygiene, sanitation, the use of Standard Operating Procedures (SOPs), and Good Documentation Practices (GDPs). It also addresses the top 5 observations cited in FDA Warning Letters since 2010 which are Specifications, Master Manufacturing and Batch Production Records, Quality Unit (collectively Quality Assurance and Quality Control) Responsibilities, Product Complaints, and Holding and Distribution Operations.
A Two-part EAS Online Exclusive