This course provides technicians and other life-science professionals with a practical introduction to Current Good Manufacturing Practices (CGMP) for pharmaceutical and biomanufacturing operations. Participants learn the regulatory foundations of CGMP (21 CFR Parts 210 and 211), the role of Pharmaceutical Quality Systems (PQS), and how quality systems support product quality, patient safety, and regulatory compliance. The course also introduces modern quality concepts including lifecycle thinking, quality culture, electronic systems, and global regulatory expectations associated with contemporary pharmaceutical manufacturing, including foundational concepts from ICH Q7, Q8, Q9, and Q10.
- Manufacturing/Production Operators
- Team Leaders and Supervisors
- Quality Control Personnel
- Quality Assurance Personnel
- Validation/Engineering Personnel
- Laboratory Personnel
- Technical Support Staff
- Materials Management Personnel
- Maintenance/Facilities Personnel
- Other associates working within pharmaceutical, biotechnology, or biomanufacturing operations requiring an understanding of Current Good Manufacturing Practices (CGMP) and Pharmaceutical Quality Systems (PQS).
- Contamination Control
- Process Controls
- Documentation and Data Integrity
- Investigations
- CAPA Systems
- Inspection Readiness
- Continuous Improvement (CI) within GMP-regulated environments
By the end of the course, students will be able to:
- Explain the purpose and regulatory foundation of Current Good Manufacturing Practices (CGMP) within pharmaceutical and biomanufacturing environments.
- Describe how Pharmaceutical Quality Systems (PQS) integrate manufacturing controls, documentation practices, investigations, and continuous improvement to support product quality and patient safety.
- Discuss FDA and international regulatory expectations related to pharmaceutical manufacturing, including 21 CFR Parts 210 and 211, ICH Q7, ICH Q8, ICH Q9, and ICH Q10.
- Recognize the importance of facilities, equipment, contamination control, personnel practices, and manufacturing controls in maintaining product quality within GMP-regulated operations.
- Identify the role of Good Documentation Practices (GDP), data integrity principles, electronic records, and 21 CFR Part 11 within regulated quality systems.
- Describe the relationship between manufacturing controls, laboratory controls, deviations, CAPA systems, change management, and inspection readiness.
- Recognize common FDA inspection findings, enforcement activities, and quality-system weaknesses associated with CGMP noncompliance.
- Discuss modern quality-system concepts including lifecycle thinking, quality culture, risk-based decision-making, and continuous improvement.
Delivered in-person in a classroom or lab setting.
A combination of online and in-person components.
Delivered online with a live instructor at a scheduled date and time.
This course provides technicians and other life-science professionals with a practical introduction to Current Good Manufacturing Practices (CGMP) for pharmaceutical and biomanufacturing operations. Participants learn the regulatory foundations of CGMP (21 CFR Parts 210 and 211), the role of Pharmaceutical Quality Systems (PQS), and how quality systems support product quality, patient safety, and regulatory compliance. The course also introduces modern quality concepts including lifecycle thinking, quality culture, electronic systems, and global regulatory expectations associated with contemporary pharmaceutical manufacturing, including foundational concepts from ICH Q7, Q8, Q9, and Q10.
- Manufacturing/Production Operators
- Team Leaders and Supervisors
- Quality Control Personnel
- Quality Assurance Personnel
- Validation/Engineering Personnel
- Laboratory Personnel
- Technical Support Staff
- Materials Management Personnel
- Maintenance/Facilities Personnel
- Other associates working within pharmaceutical, biotechnology, or biomanufacturing operations requiring an understanding of Current Good Manufacturing Practices (CGMP) and Pharmaceutical Quality Systems (PQS).
- Contamination Control
- Process Controls
- Documentation and Data Integrity
- Investigations
- CAPA Systems
- Inspection Readiness
- Continuous Improvement (CI) within GMP-regulated environments
By the end of the course, students will be able to:
- Explain the purpose and regulatory foundation of Current Good Manufacturing Practices (CGMP) within pharmaceutical and biomanufacturing environments.
- Describe how Pharmaceutical Quality Systems (PQS) integrate manufacturing controls, documentation practices, investigations, and continuous improvement to support product quality and patient safety.
- Discuss FDA and international regulatory expectations related to pharmaceutical manufacturing, including 21 CFR Parts 210 and 211, ICH Q7, ICH Q8, ICH Q9, and ICH Q10.
- Recognize the importance of facilities, equipment, contamination control, personnel practices, and manufacturing controls in maintaining product quality within GMP-regulated operations.
- Identify the role of Good Documentation Practices (GDP), data integrity principles, electronic records, and 21 CFR Part 11 within regulated quality systems.
- Describe the relationship between manufacturing controls, laboratory controls, deviations, CAPA systems, change management, and inspection readiness.
- Recognize common FDA inspection findings, enforcement activities, and quality-system weaknesses associated with CGMP noncompliance.
- Discuss modern quality-system concepts including lifecycle thinking, quality culture, risk-based decision-making, and continuous improvement.
Delivered in-person in a classroom or lab setting.
A combination of online and in-person components.
Delivered online with a live instructor at a scheduled date and time.