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Training Options  Duration: 60 Minutes   Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) Price: $295.00 Refund Policy

by James Harris 
Overview: 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.

Why should you attend:
Every well run pharmaceutical manufacturing facility has established a team of its personnel who will be responsible for hosting an FDA inspection, providing assistance as needed, and monitoring their activities. This program is a vital preparation for the inevitable FDA inspection. It will help sharpen your skills and prepare team members for the inevitable day of inspection This presentation will prepare a manufacturer for FDA inspections, suggest methods for managing the inspection, and assure a smooth and pleasant inspection.

Areas Covered in the Session:

• Basic Preparation
  
• The host team
  
• Rules
  
• FDA’s arrival
  
• The inspection
  
• Typical points of FDA interest and how to handle
  
• Validation
  
• The exit interview
  
• The 483
  
• What to do after FDA leaves
  
• Follow-up inspections
  
• What to avoid

Who Will Benefit:

• Production supervisors, Managers, and Directors
  
• Quality Control and Quality Assurance supervisors, managers, and directors
  
• Inspection host team