Preparation for GMP Inspections by Regulatory Agencies

Why Should You Attend:

Regulatory agencies conduct product-related GMP inspections when assessing an application for marketing approval. This inspection checks if the manufacturer complies with GMP principles and practices from ICH and the local region.

Product-related inspections may also be conducted if the agency is informed or suspects a possible GMP breach. This may be triggered by a whistle blower, an inspection for other products manufactured in the facility, or inspections conducted by other regulatory authorities.

Inspections may be announced or conducted spontaneously.

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.

Areas Covered in the Webinar:

• Types of Inspections (for cause, pre-approval, periodic ) - API & FDF
• Notification timing
• Foreign facilities
• What to expect during inspection
• Doing a company audit as the FDA would (fall dress rehearsal)
• Making adjustments as needed/address issues/taking needed actions
• Managing the inspection
• Inspection on follow-up

Who Will Benefit:

The following professionals from all FDA regulated industries will benefit from this training:

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

Instructor Profile:

Peggy J. Berry, MBA, RAC, is the president and 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. Prior to Insmed, she was vice president of regulatory affairs and quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held regulatory affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).

In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

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