John G. (Jerry) Lanese Ph.D.
President, The Lanese Group, Inc.

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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. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. 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 best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry.

Jerry has been active in the Kansas Award for Excellence program, a Baldrige Criteria based program, for the past fourteen years and is currently the Director of that Program. He served as a Baldrige Examiner in 2008 and will be will a Baldrige Examiner in this year.

On the personal side, Jerry is active in two Toastmasters clubs in the Overland Park, KS area and is the president of Kansas City Ragtime Revelry, an organization that promotes ragtime music.

Areas of Expertise

Quality Systems: Baldrige, Kansas Award for Excellence, ICH Q10, FDA Guidance

Laboratory Controls: Method Validation, OOS, Calibration, Reference Standards

Quality Management Concepts: - Annual Review, Calibration, Investigations

Training: GMPs, Compliance, Quality Systems, Quality System Concepts.

The Lanese Group Company profile

The Lanese Group, Inc. is an independent consulting firm, which provides quality management resources to a wide range of organizations with a focus on the FDA regulated industries. Dr. Jerry Lanese, company president, has more than thirty years of experience in the pharmaceutical industry. In recent years, Dr. Lanese has been involved in a number of projects which emphasize current quality system concepts within the FDA regulated industries. He has also been involved with Baldrige-based Quality System programs for fifteen years providing experience in the application of quality systems in health care, production and education environments.

In many projects Dr. Lanese has been a member of a project team. This has brought him in contact with other consultants, consulting firms, and project management organizations. The Lanese Group, Inc. has developed strategic alliances with individual consultants and several organizations and cooperates with these to provide a complete consulting service package.

Dr. Lanese and The Lanese Group, Inc. also develop and present training sessions, seminars and informational talks for the industry and civic groups. Many of the training units have been presented as part of seminars arranged by national seminar providers or strategic partners. Training sessions can be customized for clients.

The Lanese Group can bring quality management system and training experience as an integrated consulting service to help client firms from all business sectors remain compliant to the most current interpretation of the regulations, implement quality systems and promote good business practices.

In recent years The Lanese Group has managed the Kansas Award for Excellence Program the Kansas State Baldrige-based Quality and performance improvement program.