Session 1 Objectives

Auditing
• Define principles of auditing
• Develop an effective audit program
• Describe the basic steps or phases of an audit
• Develop audit tools
• Review an audit report and follow-up
• Perform an audit

Document Control
• Identify the regulatory requirements for document control
• Recognize and implement Good Documentation Practices
• Describe how policy, process and procedures are developed and controlled, retained and archived
• Review formats for document development

FDA and JCAHO
• Outline the steps of Biological Product Deviation Reporting
• Describe a reportable event versus a non reportable event
• Prepare a fatality report for the FDA
• Define a JCAHO sentinel event and be able to outline the steps of reporting

Quality Basics
• Explain why quality is important
• Define the core concepts of Total Quality Management (TQM) and Process Improvement
• Define seven commonly used quality tools and how they are applied to problem solving

Validation
• Define Validation and the terms used in validation process
• Describe the elements of validation
• Differentiate between validation and verification/qualification.
• Define Prospective and Retrospective Validation
• Develop a Validation Plan

Deviation Management
• Define the terms associated with management of errors, deviations and unexpected events.
• Structure an effective system for processing deviations.

Facilities, Equipment and Calibration
• Describe the role of facility design in promoting quality
• Discuss regulatory requirements and/or recommendations for maintaining facilities and equipment
• Discuss elements of equipment calibration
• Discuss the components of a preventative maintenance program
• Describe what should be included in an equipment file

Nonconforming Products
• List regulatory requirements
• Define terms for nonconforming materials
• List elements of a Material Review Board (MRB) program
• Review the rationale behind the MRB process
• Describe methods for handling nonconforming materials

Regulatory Affairs and Compliance
• Discuss the regulatory history of the FDA
• Define agencies and regulations that impact the blood industry
• Define FDA registration
• Discuss the external inspection process
• Outline a method for review of new standards and guidances