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Nilsen's 4-Step System for OOS Elimination

(Now bundled with Analytical Method Validation SOP and Template and the Pharmaceutical Master Validation Plan Products)

Price $250.00    ORDER NOW!

One of the biggest FDA HOT BUTTONS is how a firm handles out of specification (OOS) lab results. Lab errors should be rare, and with this system, they will be.

Just one OOS investigation will cost more than the price of this product. Using this system, it is estimated that at least 95% of all OOS results will be eliminated, and those that do occur, will generally be explainable.

Order today and eliminate or greatly reduce regulatory exposure due to laboratory error.

Save thousands of dollars in investigative costs and unwanted negative regulatory exposure.

Avoid unnecessary Warning Letters and 483 Observations.

DOZENS OF COPIES ALREADY SOLD - ORDER YOURS TODAY; YOUR COMPETITORS ALREADY HAVE.
Details:
4-Step system includes:

>Identification and explanation of dozens of lab techinque deficiencies.

>Training and testing of analysts to identify and correct personal lab skill deficiencies.

>OOS results - what they are and what they're not. This critical section can help avoid a large percentage of OOS results.

>Chromatography practices designed to prevent most OOS results.

>Sample SOPs for Basic Labs Skills procedures, OOS investigations and optimum chromatography practices.
    Continuous Process Improvement & Quality Systems for Regulated Industries

    NILSEN CONSULTING
    1340 Roudenbush Road
    Quakertown, PA 18951
    Phone: 215-538-7863

    Email: cnilsen@nilsenconsulting.com