Benastrum

As the FDA places greater emphasis on change control systems during facility inspections, these systems must become more effective, flexible and compliant.  Change control has always been a critical aspect of pharmaceutical Quality Assurance, and it is with that in mind that the FDA is focused on modernizing the GMP’s, significantly increasing the importance of well constructed systems.  The FDA is currently in the process of revising GMP regulations regarding changes to approved NDA and ANDA’s, hoping to move towards “management-based regulations” that will offer manufacturers increased flexibility yet place greater emphasis on each manufacturer’s control system.  The agency has stated that change control systems will be the primary focus of future facility inspections.

The FDA recognizes that changes made without proper evaluation and implementation will lead to catastrophic consequences for both patient and practitioner.  During this live and interactive web seminar, Charles Levine will outline the key elements of an effective risk-based change control system, satisfying both current and future requirements.  The presentation will also include a number of case studies and allow participants to present their individual cases for discussion.

Discussion points will include:

• Current FDA regulations regarding changes
• Current FDA guidance regarding changes
• FDA’s new change control concept
• Elements of an effective quality system
• Elements of an effective change control system
• Incorporating risk analysis into change control systems
• Implementing changes in a controlled fashion
• Actual case studies

Learning Benefits:

• Develop and implement change control systems that control but do not stifle change.
• Develop a better understanding of current FDA regulations and guidance regarding changes to approved ANDA’s and NDA’s.
• Gain insight into current FDA thinking regarding future change control regulations
• Identify the level of documentation and qualification required for a variety of changes
• Understand the role of Quality Assurance data systems in the evaluation of proposed changes
• Identify formal risk analysis tools to be used in the evaluation of proposed changes