Deviation management system
Overview: This course will review the regulatory requirements and expectations for the deviation management process, describe the roles and responsibilities of personnel associated with the investigation system, and identify principles of and techniques involved in the practice of facilitating a root cause analysis. Additionally, the sources of deviations and investigations will be examined as well as documentation of the process.
Why should you attend: Inadequate failure investigations continue to be a major GMP deficiency cited during routine regulatory inspections. Most often, companies are cited due to a lack of knowledge of the regulatory expectations and guidance, and not developing the essential skills necessary to ensure effective and efficient investigations. This program will examine each step of an effective investigation process from identification and notification through root cause analysis and development of corrective and/or preventive actions. This material will review FDA and EU regulations, and how to successfully approach a failure investigation and engage in subsequent root cause analysis.
Areas covered in the session:
FDA requirements
EU requirements
Landmark case
Elements of the investigation process
Skills and tools of the investigator
Root cause analysis techniques
CAPA
Who will benefit:
Investigators
Quality assurance
Laboratory supervisors
Complaints manager
CAPA manager
Quality assurance
Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of quality operations, audits and inspections, laboratory, human resources, and learning and development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/quality management system manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and process safety management training, as well as internal and external public relations.
Kerry is a graduate of James Madison University in Harrisonburg, VA (B.S. in Chemistry) and is an advanced Toastmaster. He has received qualifications and certifications in the areas of facilitation and training, including competency-based curricula. His past affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI, and AQP. Kerry is the founder of Summit Consulting, Inc. and has been assisting firms in the areas of remediation and project management within the manufacturing and the laboratory functions for the past two years.
Date: 25 September 2012Time: 10:00 - 11:00
Venue: Online Training, Wilmington
Cost: $245.00
More info:
Online Training