FDA cGMP Implementation Course

Description:
This course begins with a review and explanation of the Gap Analysis Assessment Report, and provides a practical approach to evaluating and preparing documentation and processes needed to implement a US FDA cGMP quality management system. Participants learn how to analyze cGMP documentation and process requirements. In addition, organizational processes are thoroughly reviewed and identified.

Course Topics Include:

• Reviewing the Gap Analysis Report
• Reviewing the requirements of cGMP's
• Reviewing and discussing specific examples of required documentation
• Identification and discussion of specific organizational processes
• Assignment of responsibility to complete specific tasks
• Completion of a Project Plan
• Training of other personnel within the organization

Who Should Attend?
Process Owners within your organization and top management within the proposed scope of registration.

Prerequisites:
No prior knowledge of cGMP's is required. Participants should read the Gap Analysis Report prior to attending the course.

Duration: 2 Days (16 hours)

Type: On-Site Training

Price: $7500 (for up to 15 people)

Optional Third Day can be added to this course to map organizational processes using MS Visio for an additional $2500. Process Owners would bring additional employees into this third day to work on mapping their specific processes. NOTE: The organization must purchase its own copy of MS Visio. The course price does not include a copy of this software.

For information on the complete Process Mapping Workshop, please click here.