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Validity : 20th Apr'25 to 30th Apr'25
Good Documentation Practices
- Documents to which GDP applies
- Decisions to be made in setting up the company GDP
- Areas to be contained within the company’s GDP policy/training
- How to properly write, manage and correct documents
Overview of the webinar
Documentation is fundamental to adequately demonstrating that GMP and GCP compliance was employed during product development and commercialization. Documentation needs to meet certain requirements to ensure data validity, product quality and product safety. If these records are poorly prepared or completed, then the clinical data obtained may not be adequately verified or relied upon by the regulatory agency to issue and approval and the manufacture or quality of a product can be negatively impacted. Therefore, it is imperative that Good Documentation Practices be followed throughout the process to ensure that regulatory requirements are met. The standard of documentation within a company can directly impact the level of success in achieving approval of drugs and manufacturing quality products that are safe.
Who should attend?
- Vice Presidents, Directors & Managers of GMP & GCP areas
- Employees involved in any area covered by GMP or GCP
- Audit and Compliance Personnel / Risk Managers
Why should you attend?
- What are the mandatory document requirements
- Which documents are critical to the regulatory agencies
- How should GDP be employed by the company
- What are the principles of GDP
- Defining the company policy and procedure for each relevant element of GDP
- Managing attachments and printouts to originally created documents
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).