The course is structured around the Launsby Process Validation Model (PVM), shown below, and includes (but is not limited to) the topics as described:

• Day 1
  • Introduction
  • Process Validation - The FDA Quality Systems Regulation (QSR)
  • The Process Validation Model
  • Validation Components
  • Installation Qualification (IQ)

• Day 2
  • Operational Qualification (OQ)
  • Validation Tools
  • Sample size determination
  • Statistical analysis
  • Measurement System Analysis (MSA)
  • Process capability
  • Design of Experiments - Part One
  • Design of Experiments - Part Two
  • Performance Qualification (PQ)
  • Monitoring
  • Revalidation

Guarantee of Satisfaction/Refunds for Cancellations

Launsby Consulting seminars and products are fully guaranteed. If any of our seminars do not meet your needs, contact us and we will promptly send you a refund. If any of our products fail to meet the highest standards of quality and performance, please return them in like-new condition in their original packing materials, and we will send you a refund.

When cancellations are made at least 14 days prior to the seminar date, we will refund your registration fee minus a $100 processing fee.