ComplianceOnline Webinar - Best Practices for Writing an Effective SOP to Lead to Successful FDA Ins (FDA Validation Train)
Venue: Online Event
|Event Date/Time: Oct 07, 2010||End Date/Time: Jul 07, 2010|
It is inevitable, that every FDA regulated firm, at some time will be inspected by the FDA. But are you ready?
To be adequately prepared, a firm must be proactive and strategically prepare for a FDA or other Regulatory audits to assure a successful outcome. In addition to a mock FDA audit, preparation needed for the implementation of an effective Standard Operating Procedure (SOP) for managing FDA Investigators and other regulatory auditors when on-site. This procedure will document the firm's audit policies and describes "how to" best practices procedures so that your staff is prepare for outside auditors. Implementing these procedures will assure that key personnel are properly trained and prepared, and may have significant influence on the outcome of the audit. Without these procedures, your firm may be placing itself at risk to additional and unnecessary FDA and other Regulatory Investigator scrutiny.
In this SOP best practices course, you will understand the key policies and procedures that must be included in your SOP and how to properly manage FDA investigations for the best outcome. After the course, you will be able to either critically review your current SOP, if you have one, or this course will definitely help you and your staff to develop a "state of the art" SOP.