Session 3 Objectives

HCT/Ps
• Define FDA’s Good Tissue Practices
• Differentiate between requirements for cadaver tissues, cellular therapy products and reproductive tissue
• Discuss the FDA regulations and review the core CGTP
• Describe the requirements for a quality program, handling of complaints, adverse reactions and deviation reporting
• Explain labeling requirements

Clinical Trials
• Define the purpose of research and the regulatory requirements
• Outline the phases of clinical trials
• Discuss FDA’s BIMO program
• Describe what could be covered during an FDA inspection
• Discuss regulatory actions, fraud and the consequences

Part 11
• Explain the purpose of 21 CFR Part 11
• Define key terms from Part 11
• Discuss the historical prospective of the regulation and where it stands today
• Identify what blood center records apply to Part 11
• Review how Part 11 will be enforced
• Outline what steps to take to work towards compliance

Advanced Auditing
• Develop an effective audit
   – Why do we miss items the external agencies find
• Discuss and develop effective audit tools
• Discuss different audit approaches
• Discuss weighted findings and audit scoring
• Be able to audit the quality system
• Discuss different reporting methods
• Review what is an effective follow-up

Ethics
• Define ethics in the workplace and in blood establishments
• Describe key elements of an ethics policy
• Link ethics to quality
• Establish a “hotline” process

Investigations
• Describe a process to conduct a facility investigation into a problem or issue of significant magnitude
• Perform a risk analysis and hazard assessment on pre-defined scenarios
• Report to the FDA
• Perform a system-wide assessment
• Apply standard investigative techniques

European Union Requirements
• Describe the various components of EU requirements and how they apply to blood establishments
• Outline the standards that apply
• Develop an EU assessment tool
• Perform an EU assessment

Six Sigma White Belt
• Learn methodology and “language” of Six Sigma
• Apply basic Six Sigma problem solving tools to regular activities such as deviation management and process improvement using the DMAIC approach: Define, Measure, Analyze, Improve and Control