BIOT 125: Quality and Regulatory Practices in Biotechnology

• Define quality and apply the term appropriately.
• Differentiate between quality control and quality assurance in the bioscience industry.
• Explain the role of validation and its importance in regulatory compliance for the bioscience industry.
• Select, define, and apply basic quality improvement tools.
• Describe the importance of using data to drive continuous improvement, and identify key quality factors.
• Select and define various customer feedback mechanisms.
• Identify and assess supplier performance measures.
• Describe and distinguish between quality theories and philosophies.
• Identify key historical events that shaped FDA regulations and quality systems in the biosciences.
• Discuss how regulatory bodies (including FDA) impact bioscience company operations and the work performed by technicians.
• Explain why teams are an effective way to identify and solve problems.
• List the stages of team formation.
• Describe and distinguish the various types of teams, and identify which team is best suited for a particular situation.
• Explain the purpose of a quality management system (QMS), its major components, and how it benefits an organization.
• Describe the main types of QMS documentation used in the bioscience industry.

Introduction to Quality Concepts

1. Definition of quality
2. History of quality
3. Pioneers of quality and their contributions
4. Overview of quality philosophies
5. Benefits of quality for organizations and stakeholders
6. Quality plans and their purpose
7. Applications of quality concepts

Team Basics

1. Value of teams
2. Types of teams
3. Roles and responsibilities of team stakeholders
4. Team formation and evolution
5. Decision-making and conflict resolution within teams

Introduction to Bioscience Regulations

1. History of the Food and Drug Administration (FDA)
2. FDA's mission and organizational structure
3. Overview of the Code of Federal Regulations (21 CFR)
4. Regulation of the pharmaceutical, medical device and food industries
5. Exploration of Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP)
6. Other regulatory bodies, including international oversight

Quality Management

1. Quality management and consequences of non-compliance
2. Definition of Quality Management Systems (QMS)
3. Supplier, input, process, output, customer (SIPOC)
4. ISO and Baldrige standards
5. Documentation: standard operating procedures, change control, and Good Documentation Practices (GDP)
6. Quality Control: analytical and microbiological
7. Quality Assurance: corrective and preventive actions, investigations, root cause analysis
8. Validation principles

Continuous Improvement Techniques

1. Continuous Improvement: brainstorming, plan-do-check-act (PDCA), internal audits
2. Process Improvement
   1. Six sigma and Lean
   2. Incremental and breakthrough improvement
3. Quality Improvement Tools
   1. Flowcharts
   2. Histograms
   3. Pareto charts
   4. Scatter diagrams
   5. Cause and effect diagrams
   6. Check sheets
   7. Control charts

Customer-Supplier Relations

1. Internal and external customers and suppliers
2. Customer feedback mechanisms
3. Using data to drive continuous improvement
4. Supplier performance measures