Preparing for GMP Regulatory Inspections

Course Description

This course is designed for to prepare staff operating in cGMP manufacturing, quality control, quality assurance and other support functions for regulatory inspections. The information and discussion offered in this course will be particularly valuable for those responsible for hosting regulatory inspections and those who will interact with investigator and inspectors.

Background information on the regulatory agencies, including the U.S. FDA, the mission of the regulators, and elements of a successful inspection are featured in this course. The course also reviews regulator’s expectations, regulatory implications and inspection outcomes, as well as key points for inspection management and follow up. Goals for being “inspection ready” at all times is a theme throughout the course, using lecture and discussion formats to cover course topics.

Course Topics

Each course can be customized to the learning needs of a particular organization. Following is a list of topics available for this course:

• The basis for regulatory inspections
• The investigators/inspectors and their agencies
• U.S. FDA
• EMEA
• Other Regulatory Agencies
• cGMP Regulations, guidance, standards and other requirements
• Implications and regulatory action

• Pre-approval, Routine surveillance, Directed
• Receiving investigators/inspectors
• During the inspections
• The notice of Observations
• The response and corrective action

• Knowing the requirements
• Procedures
• Preparation
• Staffing
• Logistics
• Presenting the organization
• Facility Tours
• Reviewing documents and records

Instructors

• Frank Matarrese, GxP Consultant