ComplianceOnline

Method Validation: Yesterday, Today and Tomorrow

Instructor: Steven Walfish
Product ID: 705439
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$279.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Oct-2017

Training CD / USB Drive

$379.00
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CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar will focus on analytical method validation and its evolution to be a risk based process using statistical concepts. The idea of an Analytical Target Profile (ATP) in the context of target measurement uncertainty (TMU) will be explored.

Why Should You Attend:

Analytical method validation has been evolving since the release of ICH Q2R1 in 1994. The definition of “fitness for use” was tied to the method. Future validation activities need to be tied to the product, including a risk profile.

This webinar covers the origins of method validation from ICH Q2R1 to the proposed lifecycle management concepts for analytical method validation.

The regulatory landscape for analytical method validation is changing rapidly as industry is adopting a lifecycle approach to method development and validation.

This webinar will discuss how these changes impact analytical chemists. Some of the newer concepts to be covered include the analytical target profile, risk assessment, focus on the reportable value, use of decision rules, and replication strategies.

Areas Covered in the Webinar:

  • Accuracy and Precision
  • Analytical Target Profile (ATP)
  • Target Measurement Uncertainty (TMU)
  • Control Strategies

Who Will Benefit:

  • QA managers and personnel
  • Quality control personnel
  • Product development scientist
  • Method development personnel
  • Analytical chemists
  • Validation specialists
  • Laboratory managers and supervisors
  • Regulatory affairs professionals
Instructor Profile:
Steven Walfish

Steven Walfish
Principal Scientific Liasion, United States Pharmacopeia

Steven Walfish is Principal Science & Standards Liaison at United States Pharmacopeia (USP). Prior to this role Mr. Walfish was Principal Statistician at BD in Franklin Lakes, NJ. He was responsible for supporting continuous improvement efforts and process development for worldwide operations. Prior to BD he was a statistician at GE Healthcare in Waukesha, WI. Formerly, Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.

Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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