Speaker Profile


Jerry Lanese

President, The Lanese Group, Inc.

John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Dr. Lanese focuses on the development of Quality Systems and trains extensively on related topics. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. Jerry is a member of the Editorial Board of the Journal of GXP Compliance and co-edits a continuing column, “GXP Talk” in the Journal of GXP Compliance.

  •  Wednesday, August 8, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Analytical Method Validation

An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

  •  Wednesday, August 29, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
Laboratory Investigation of Out-of-Specification Results

The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

  •  Friday, September 14, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
cGMPs in the Quality Control Laboratory

Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.

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  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤189.00
Analytical Method Validation

An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤189.00
cGMPs in the Quality Control Laboratory

Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
Laboratory Investigation of Out-of-Specification Results

The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
Laboratory Investigation of Out-of-Specification Results

The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

View All

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