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Validity : 21st Apr'24 to 01st May'24
Recent FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies
- Changes in FDA audit approaches
- Most common cited GMP drug deficiencies for 2012-2015
- Increase in FDA enforcement actions
- How best to address FDA 483 observations when received
Overview of the webinar
This training program will provide attendees with a better understanding of the current audit techniques used by FDA and how they have changed over the years. In addition, areas of increased regulatory scrutiny will also be discussed such as data integrity issues. Additionally, the webinar will provide an overview that companies can use to evaluate their own state of compliance by knowing what have been the most common cited GMP deficiencies over the last several years.
Who should attend?
- Quality Assurance
- Quality Control
- Manufacturing
- Production
- Regulatory
- Laboratory Personnel
- Management
- Equipment Vendors
Why should you attend?
The success of getting through any audit by federal regulators and third-party audits is not only dependent on a well-prepared training of all staff and department employees, but also in knowing what the focus has been of recent inspections within the industry. Such information provides a template for companies to look closely at their own practices in helping to assure similar findings are adequately addressed. In addition, as the audit techniques of the FDA have changed over the years, knowing what to expect can help establish a focused training program as part of the preparation.
This webinar will look at changes in the FDA’s approach to audits and the current method used by the agency to determine audit frequencies by using a system of risk assessments. The top 10 most cited GMP deficiencies for drug manufacturers over the last three years (2012-2015) will be reviewed along with the significant increase in the number of warning letters issued over the last 4 years. Actual case examples will be used to highlight various points discussed and attendees will get a chance to ask questions throughout the presentation.
Faculty - Ms.Peggy J.Berry
Peggy J. Berry, MBA, RAC, is the president and CEO of 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).