John G. Lanese
President at The Lanese Group, Inc
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr.Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.

In 1994 Dr. Lanese formed his own company, The Lanese Group, since then he has been a consultant in the area of quality system and cGMP compliance and has been consulted by small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.

Dr. Lanese lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article "Training and the Laboratories" was selected as the best article of the year by the Journal of GXP Compliance. In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry. Jerry is a member of the Editorial Board of the Journal of GXP Compliance.

Upcoming Webinar
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Recorded Webinar
Laboratory Instrument Calibration: Current FDA Regulatory Requirements and Best Practices
This web seminar builds on the terminology found in 21CFR160 (b)(4) and introduces terminology and concepts not found in the regulation, but necessary for an effective calibration program, such as instrument classifications. It applies measurement uncertainty or test accuracy ratio to specific calibration procedures and the selection of standards to provide scientifically sound calibrations traceable to national references. The discussion applies the concepts discussed to specific key instruments found in the testing laboratory.
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Quality Metrics Program: FDA Challenges and Requirements including the New 'Quality Metrics Technical Conformation Guide' Released June 2016
The Food, Drug and Cosmetic Act of 1938 as revised by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2014, gives the FDA the authority to require the reporting of Quality Metrics. In July 2015 the FDA issued a draft guidance, 'Request for Quality Metrics' in which the Agency shared its plan to require all firms that market a drug substance or drug product in the U.S. to provide specific data to the FDA which it will use to calculate defined quality metrics. This was recently followed, in June 2016, by an addendum, 'Quality Metrics Technical Conformance Guide' which clarifies the format of the metrics that must be submitted.
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Out of Specification Investigations in the Laboratory
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. This live webinar training will provide a clear process for compliant laboratory OOS investigations.
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Annual Product Quality Reviews: 2015 FDA, EU & Canada Regulatory Requirements
In this webinar we will discuss the Annual Product Review (APR), or Annual Product Quality Review. The discussion will include the regulatory requirements found in the US, EU and Canadian GMPs. It will itemize what should be covered in the APR and the use of risk analysis to identify the critical data. The emphasis will be on the defined purpose of the Annual Product Review - to identify areas for product and process improvement. The discussion will also point out that the recent US and EU guidances on process validation will bring new purpose and visibility to the Annual Product Review.
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Annual Product Quality Reviews ; Preparation & Reports - 2015 FDA, EU & Canada Regulatory Requirements
Product reviews are often requested by regulatory investigators. Annual Product Reviews have been a requirement of the US GMPs for pharmaceutical products since 1978. More recently EU and Canada have included a requirement for Annual Product Quality Reviews in their regulations or guidances covering drug products. Inadequate Annual Product Reviews has been the subject of US FDA 483 observations and Warning Letters. The concept of ongoing product, process and system reviews is a vital part of the philosophy of continuous improvement found in the Pharmaceutical Quality System outlined in ICH Q10 and the FDA Guidance to the Industry: "Quality Systems Approach to Pharmaceutical GMP Regulations". More recently, the product review has been referenced as a mechanism for verifying that a process continues in a validated state in the FDA Process Validation Guidance. Product Reviews are a vital component of an effective Quality System.
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Thorough and Complete Investigations and Follow-up -- Current Regulatory Expectation
In this webinar we will discuss the current regulatory expectation on how a firm identifies deviations, problems and trends, investigate these to determine the cause, recommend corrective and preventive actions. It would also explain how to complete these actions and demonstrate that the actions accomplished the intended correction or prevented the repeated occurrence of the problem.
Recorded Session Get life time access for one participant with download option!

Out-of-Specification Investigations, Identifying the Attributable
Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of OOS test observations 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. This live webinar training is to provide a clear process for compliant laboratory OOS investigations.
Recorded Session Get life time access for one participant with download option!

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