The Center for Professional Innovation & Education, Malvern, PA
Who Should Attend
This advanced two-day training course is intended for Pharmaceutical and Medical Device Professionals who want to increase their knowledge and understanding of how to best comply with current regulations and prepare for a Systems-based Inspection. Specifically, the following professionals will benefit from taking the course:
-Quality Systems Managers/Directors
-GMP Compliance Specialist
-GMP Training Managers
Quality management methods have undergone significant changes since 1978 when the CGMP regulations were last updated. The regulatory changes made by the Food and Drug Administration (FDA) are designed to ensure that the pharmaceutical and medical device industry continually update their practices to stay fully compliant. As a result, beginning in the fall of 2004, the FDA began using a risk-based approach for prioritizing domestic manufacturing site inspections for pharmaceutical manufacturers.
In order to keep pace with the many advances in manufacturing quality management and to enable the FDA to more effectively allocate its limited regulatory resources the Agency is implementing a risk-based approach, as well as, a comprehensive quality-systems model for pharmaceutical manufacturing inspections. This course provides a comprehensive overview of the FDA's systems-based inspection technique, especially since, under the systems-based inspection approach, “if any one system is 'out of control' an entire firm will be considered 'out of control.'"
"FDA’s new Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations," describes how a comprehensive quality systems (QS) model if implemented, will allow manufacturers to reach a higher level understanding of their own operations and create a more robust modern quality system that is fully compliant with CGMP regulations.
This course was created to help organizations prepare and develop the necessary structure for an FDA Systems-based Inspection using the Risk-based Inspections approach and to proactively help anticipate and avoid potential 483's and warning letters.
Participants will learn how to identify the differences between the systems-based inspection and previous inspection strategies. Attendees will review high risk systems using the FDA’s emphasis on a risk-based approach and also analyze each of the systems as defined by FDA both from the new pharmaceutical manufacturing systems as well as the inspectional QSIT (Quality System Inspection Technique) approach currently used to inspect Device Manufacturers. Included will be what FDA calls the “Six-system Inspection Model” as follows:
2.Facilities and Equipment System
5.Lab Control Systems
6.Packaging and Labeling System
In addition, Participants will learn how to write Standard Operating procedures for the following systems:
-Resources - Effective training programs
-Risk Management and Risk Assessment
-CAPA (Corrective and Preventive Action)
Issues to be covered include:
-Learn how the FDA has identified a risk-based approach as one of the driving principles of the CGMP initiative
-How the FDA believes the use of risk management principles will enhance the Agency's inspection and enforcement program
-How one can define areas in which to focus when preparing for a Systems-based Inspection
-Analyze each system as defined by the FDA
-Recognize and assess the potential impact of non-compliance
-Learn how the FDA defines a state of control
-Determine what investigators are looking for during a systems-based inspection
-Develop an effective strategy to prepare for an inspection