Course Curriculum

    1. Welcome Video

    2. Process Validation Expectations (Part 1)

    3. Process Validation Expectations (Part 2)

    4. Process Validation Expectations (Part 3)

    5. Process Validation (PV) Terminology

    6. PV Terminology Quiz

    7. Regulations: United States (Part 1)

    8. Regulations: United States (Part 2)

    9. Regulations: United States (Part 3)

    10. Regulations: ISO (Part 1)

    11. Regulations: ISO (Part 2)

    12. Global Harmonization Task Force (GHTF)

    13. Device Development vs. Process Development

    14. Regulatory Harmony

    15. Regulations Quiz

    1. Chapter Two Video

    2. Elements of a Process (Part 1)

    3. Elements of a Process (Part 2)

    4. Elements of a Process (Part 3)

    5. Example Process Inputs

    6. Process Validation Requirements

    7. Process Validation Requirements - Handout

    8. Validation vs. Verification

    9. Process Validation Concepts (Part 1)

    10. Process Validation Concepts (Part 2)

    11. IQ, OQ, and PQ Basics (Part 1)

    12. IQ, OQ, and PQ Basics (Part 2)

    13. Retrospective Validation (Part 1)

    14. Retrospective Validation (Part 2)

    15. Retrospective Validation Quiz

    16. Re-Validation (Part 1)

    17. Re-Validation (Part 2)

    18. Re-Validation (Part 3)

    19. Re-Validation Quiz

    20. Process Validation Decision (Part 1)

    21. Process Validation Decision (Part 2)

    22. Process Validation Decision Quiz

    23. Validation Master Plan (VMP) (Part 1)

    24. Validation Master Plan (VMP) (Part 2)

    25. Validation Master Plan (VMP) Quiz

    1. Chapter Three Video

    2. Process Validation Planning (Part 1)

    3. Process Validation Planning (Part 2)

    4. Process Validation Planning (Part 3)

    5. Process Validation Planning - Handout

    6. Process Validation Plan Quiz

    7. Risk Management and Statistical Tools (Part 1)

    8. Risk Management and Statistical Tools (Part 2)

    9. Risk Management and Statistical Tools (Part 3)

    10. Risk Management and Statistical Tools (Part 4)

    11. Process Validation and Risk Management (Part 1)

    12. Process Validation and Risk Management (Part 2)

    13. Process Validation and Risk Management (Part 3)

    14. Process Validation and Risk Management (Part 4)

    15. Risk Management and Statistical Tools Quiz

    16. Risk Management and Critical Quality Attributes (CQA) (Part 1)

    17. Risk Management and Critical Quality Attributes (CQA) (Part 2)

    18. Risk Management and Critical Quality Attributes Quiz

    19. Process Validation Sample Size (Part 1)

    20. Process Validation Sample Size (Part 2)

    21. Process Validation Sample Size (Part 3)

    22. Process Validation Sample Size (Part 4)

    23. Process Validation Sample Size (Part 5)

    24. Process Validation Sample Size (Part 6)

    25. Process Validation Sample Size (Part 7)

    26. Process Validation Sample Size (Part 8)

    27. Process Validation Sample Size (Part 9)

    28. Process Validation Sample Size (Part 10)

    29. Process Validation Sample Size (Part 11)

    30. Process Validation Sample Size (Part 12)

    31. Process Validation Sample Size (Part 13)

    32. Process Validation Sample Size (Part 14)

    33. Process Validation Sample Size (Part 15)

    34. Process Validation Sample Size (Part 16)

    35. Process Validation Sample Size - Handout

    36. Process Validation Sample Size Quiz

    37. PV Protocol Development (Part 1)

    38. PV Protocol Development (Part 2)

    39. PV Protocol Development (Part 3)

    40. PV Protocol Development (Part 4)

    41. Process Validation Reports (Part 1)

    42. Process Validation Reports (Part 2)

    43. Process Validation Reports Quiz

    1. Chapter Four Video

    2. Tools of the Trade (Part 1)

    3. Tools of the Trade (Part 2)

    4. Design of Experiments (Part 1)

    5. Design of Experiments (Part 2)

    6. Design of Experiments (Part 3)

    7. Design of Experiments (Part 4)

    8. Design of Experiments (Part 5)

    9. Design of Experiments (Part 6)

    10. Design of Experiments (Part 7)

    11. Design of Experiments (Part 8)

    12. Design of Experiments (Part 9)

    13. Design of Experiments (Part 10)

    14. Design of Experiments (Part 11)

    15. Design of Experiments (Part 12)

    16. Design of Experiments (Part 13)

    17. Design of Experiments Handout

    18. Design of Experiments Quiz

    19. Analysis of Variance (Part 1)

    20. Analysis of Variance (Part 2)

    21. Analysis of Variance (Part 3)

    22. Analysis of Variance (Part 4)

    23. Analysis of Variance (Part 5)

    24. Capability Studies (Part 1)

    25. Capability Studies (Part 2)

    26. Capability Studies (Part 3)

    27. Capability Studies Quiz

    28. Gage Repeatability and Reproducibility (GR&R) (Part 1)

    29. Gage Repeatability and Reproducibility (GR&R) (Part 2)

    30. Gage Repeatability and Reproducibility (GR&R) (Part 3)

    31. Gage Repeatability and Reproducibility (GR&R) (Part 4)

    32. Gage Repeatability and Reproducibility (GR&R) Quiz

    33. Maintaining a Validated State (Part 1)

    34. Maintaining a Validated State (Part 2)

    35. Maintaining a Validated State (Part 3)

    36. Maintaining a Validated State (Part 4)

    37. Maintaining the Validated State Quiz

    38. Common Validation Issues (Part 1)

    39. Common Validation Issues (Part 2)

    40. Worst Case Selection (Part 1)

    41. Worst Case Selection (Part 2)

    42. Worst Case Selection (Part 3)

    43. Worst Case Selection (Part 4)

    44. Worst Case Selection Quiz

    45. Control Plans and Charts (Part 1)

    46. Control Plans and Charts (Part 2)

    47. Control Plans and Charts (Part 3)

    48. Control Plans and Charts (Part 4)

    49. Control Plans and Charts (Part 5)

    50. Control Plans and Charts (Part 6)

    51. Control Plans and Charts (Part 7)

    52. Control Plans and Charts (Part 8)

    53. Control Plans and Charts Quiz

    54. Measurement Systems Analysis (Part 1)

    55. Measurement Systems Analysis (Part 2)

    56. Measurement Systems Analysis (Part 3)

    57. Measurement Systems Analysis (Part 4)

    58. Measurement Systems Analysis Quiz

    1. Chapter Five Video

    2. Installation Qualification (IQ) (Part 1)

    3. Installation Qualification (IQ) (Part 2)

    4. Installation Qualification (IQ) (Part 3)

    5. Installation Qualification (IQ) - Example Templates

    6. Installation Qualification (IQ) Debrief - CNC Mill Example (Part 1)

    7. Installation Qualification (IQ) Debrief - CNC Mill Example (Part 2)

    8. Installation Qualification (IQ) Debrief - CNC Mill Example (Part 3)

    9. Installation Qualification (IQ) Debrief - CNC Mill Example (Part 4)

    10. Installation Qualification (IQ) Quiz

    11. Operational Qualification (OQ) (Part 1)

    12. Operational Qualification (OQ) (Part 2)

    13. Operational Qualification (OQ) (Part 3)

    14. Operational Qualification (OQ) (Part 4)

    15. Operational Qualification (OQ) (Part 5)

    16. Operational Qualification (OQ) (Part 6)

    17. Operational Qualification (OQ) (Part 7)

    18. Operational Qualification (OQ) - Example Templates

    19. Operational Qualification (OQ) Debrief - CNC Mill Example (Part 1)

    20. Operational Qualification (OQ) Debrief - CNC Mill Example (Part 2)

    21. Operational Qualification (OQ) Debrief - CNC Mill Example (Part 3)

    22. Operational Qualification (OQ) Debrief - CNC Mill Example (Part 4)

    23. Operational Qualification (OQ) Quiz

    24. Performance Qualification (PQ) (Part 1)

    25. Performance Qualification (PQ) (Part 2)

    26. Performance Qualification (PQ) (Part 3)

    27. Performance Qualification (PQ) (Part 4)

    28. Performance Qualification (PQ) (Part 5)

    29. Performance Qualification (PQ) (Part 6)

    30. Performance Qualification (PQ) - Example Templates

    31. Performance Qualification (PQ) Debrief - CNC Mill Example (Part 1)

    32. Performance Qualification (PQ) Debrief - CNC Mill Example (Part 2)

    33. Performance Qualification (PQ) Debrief - CNC Mill Example (Part 3)

    34. Performance Qualification (PQ) Debrief - CNC Mill Example (Part 4)

    35. Performance Qualification (PQ) Quiz

    1. PV Final Exam Video

    2. Process Validation (PV) Final Exam

    3. Thank you!

    4. Medical Device Manufacturing Process Validation (PV) Course Survey
  • $2,500.00
  • 180 lessons
  • 1.5 hours of video content
  • 23 Lessons
  • Downloadable Content

Manufacturing Process Validation (PV)

Our PV course was built by practitioners, for practitioners. We have engaged with clients and regulators around the globe implementing this approach with success. We believe our approach is unlike other PV training opportunities. Our course is asynchronous with a generous 30 day time limit.

  • We start with global regulations and discuss the four types of process validations

  • We develop a clear connection with Risk Management and provide a rubric for establishing PV sample size

  • We provide a practitioners introduction and overview of key engineering tools (e.g., DoE, ANOVA, Gage R&R, MSA, Control Charts) required when conducting PV

  • We take a device or component family approach to PV leveraging a worst case view to make validations more efficient

  • Our course is heavily populated with supporting explanatory videos, downloadable definitions, examples, and a complete set a PV templates to make conducting your next validation straight forward

  • We provide a free live discussion period for PV students with one of our experts to ensure the concepts are clear