In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures.
The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old there are still many questions related to the scope and real requirements of Part 11. Attendees of this seminar will learn about basic requirements and current FDA interpretations and enforcement.
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old there are still many questions related to the scope and real requirements of Part 11. Attendees of this seminar will learn about basic requirements and current FDA interpretations and enforcement.
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
