Event Detail
Regulatory Corporate Compliance Training on FDA Inspections: What to Expect and How to Prepare
March 3, 2010
- Online DE UNITED STATES
GlobalCompliancePanel
webinars@GlobalCompliancePanel.com
When an FDA agent arrives at the front door of your manufacturing site, he fully expects to be greeted promptly and be given full access to any part of the facility and all records covering manufacturing including raw material specifications, approved suppliers, vendor audits, all analytical results run to establish raw material acceptability, in-process labeling and status identification for every container within the facility, master records, batch production records including what lots of raw material were used, detailed records of manufacture, in-process quality records, etc. While the inspector has the right to almost anything he/she wants, they do not have the right to everything. This presentation gives methods of preparation for inspections and methods of conducting and controlling the process. A simple organization that is prepared to host FDA inspectors and facilitate inspections will make the process much more satisfactory for all involved. This presentation tells how to prepare and conduct inspections and how to handle difficult moments. This presentation is essential for every pharmaceutical manufacturer and the people within that organization.