Major CGMP Issues for 2012 - Webinar By ComplianceOnline (FDA Compliance)
Venue: Online Event
|Event Date/Time: Jan 10, 2012||End Date/Time: Jan 10, 2012|
U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820). They are then required to translate those regulations into procedures and work instructions.
Many companies who have successfully done that in the past are now failing audits, facing major recall, and multi-million dollar fines. What failures in the GMPs have led to this? What assumptions have proven to be invalid? This webinar will address the above and all of the following: