Preparation for GMP Inspections by Regulatory Agencies - 2017

Overview:  

• Product Id : 501225
• Instructor : Peggy Berry
• Wednesday, April 5, 2017   |   11:00 AM PDT | 02:00 PM EDT   |   Duration: 90 Minutes

This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible, including ongoing readiness for inspections, rehearsals and preparation for successful facility inspections, and response to findings by regulatory agencies. 

Why should you Attend:

• Good manufacturing practice (GMP) is the minimum standard that a 
• manufacturer must meet in their production processes.
• This webinar will review what to expect during the Agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection. 

Areas Covered in the Session:

• Types of Inspections (for cause, pre-approval, periodic ) > API & FDF
• Notification Timing
• Foreign Facilities
• What to expect during Inspection
• Do a company audit as the FDA would (fall dress rehearsal)
• Make adjustments as needed/address issues/take needed actions
• Managing the Inspection
• Inspection on follow-up

Who Will Benefit:

• Design Engineers
• Manufacturing
• Supply chain
• Technical operations
• Quality control
• Quality assurance
• Regulatory affairs

Speaker Profile: 
Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department.

Others Details

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