Setting Acceptance Criteria for Validation

Instructor: Steven Walfish
Product ID: 700115
Training Level: Intermediate
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This Validation training will helps in validating the efforts that reflect the true process capability is critical to success.

Setting acceptance criteria for validation experiments are based on several different factors. Ensuring that the validation efforts reflect the true process capability is critical to success.The combination of Voice of the Customer and statistical methods will be investigated to develop credible methods for setting acceptance criteria.

Areas Covered in the seminar:

  • Release Specificaitons
  • Stability Specifications
  • Process Dependent Specifications
  • Confidence Intervals
  • Prediction Intervals
  • Process Capability

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • QA managers and personnel
  • Validation specialists
  • Quality system auditors
  • Consultants

Instructor Profile:

Mr. Steven Walfish is the founder and President of Statistical Outsourcing Services. He brings over 17 years of industrial experience providing statistical solutions to complex business problems. Mr. Walfish was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Mr. Walfish has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

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