"Where Compliance meets Excellence"

     
  John M. Lewis
Merck & Co., Inc.
CEO - John has over 25 years experience with diversified talents in International, Federal, State and Local quality and compliance standards and regulations within the life science industries. He is a Quality Engineer sporting a Sigma BlackBelt and is currently working together with the Board of Directors,  uniting individuals with a passion and concern for quality, compliance, education and training. John was the former CEO and Chairman of the Board of the GMPTEA and BOD Member at Large of American Red Cross, Jersey Coast Chapter.

  Kenneth Petelinkar
Bristol-Myers Squibb Co.
CFO – Ken is a veteran learning and development professional with over 18 years experience in the pharmaceutical industry leading high-performance teams.  Ken's central focus is continuous improvement of skills and knowledge while balancing risk and compliance.  Ken is a former GMPTEA Mid-Atlantic chapter president and active participant within the L&D, OD, Training, and Quality communities.

  Chrissy Frey
Novartis
CMO - Chrissy Frey graduated with her Executive MBA from the Jack Welch Management Institute (JWMI) and earned her Bachelor Science in Biology from Pennsylvania State University (PSU). In addition, Chrissy has a secondary teaching certificate from York College. Combining this education with over 20 years of pharmaceutical experience, ranging from large to start-up biological and pharmaceutical companies, she brings a plethora of experience, knowledge, and excitement to evaluating business and learning opportunities. She is a motivating and proven leader that successfully implements strategic goals and visions while aligning with business needs. Chrissy’s personal philosophy in life is that continuous improvement is mandatory for success and is a life-long process. Seeking new opportunities and challenges, as well as, growth and development learnings for her teams and self are just one of the many facets of her ideology.

  Tammy Cullen 
Eli Lilly and Company
CLO - Tammy has a PhD in Instructional Systems Technology from Indiana University and over 25 years of experience creating and conducting performance improvement programs. Currently she is a Manager of  Learning & Development with Eli Lilly, with a team that supports the Product Research and Development. She began her career in public education as a mathematics teacher and Staff Development Coordinator.

  Terrence McGinn - GXP Consultant COO - Terry is a compliance leader who is creative and motivates  individuals with an ability to manage, organize, prioritize, coordinate, and successfully accomplish all managerial assignments; particularly effective in securing the cooperation of others by providing a clear understanding of how to meet corporate objectives and achieve personal goals.

  Vince Ranieri
Johnson & Johnson
CAO - Vincent A. Ranieri has been an employee of Johnson & Johnson for nearly 14 years.  He began his JNJ career as an Assistant Scientist in 1999 with Janssen Pharmaceutica and is now the Manger, Laboratory Analyst Training & Certification Program, LATCP. He has over 25 years of medical, environmental and pharmaceutical analytical chemistry experience.  Vince has over ten years of pharmaceutical sector experience being a leader in dissolution testing.  He has earned a dissolution certification from United States Pharmacopoeia (USP) and has over 40 hours of outside dissolution training. From 2009 – 2012, Vince accepted a role as QA Training Manager in medical devices working for Integra LifeSciences putting together a compliant training system that passed challenges from U.S. FDA and several notified body assessments. A key strength is being the voice of quality and driving importance of GMPs. Vince holds a BS in chemistry from Le Moyne College in Syracuse, New York and has earned a Training Manager/Director certification from Langevin Learning Services.

  François Lavallée
d'Aliter Concept
Board Member François Lavallée is President & owner of Aliter Concepts.  “Frankie” is a certified professional training and development (CTDP) and an organizational biologist.

He uses his knowledge of molecular biology to help its clients better understand the DNA of their organization to make it more efficient and effective by using the natural catalyst for the expression of their culture: the human being!

An organizational biologist studies the structural elements of your organization to identify on which axis the work must be done to increase the organizational gravitational force to its greatest potential and thus influences the rest of the organization.

As a consultant and formative, motivating and surprising trainer, François will enable the motivational factors of your organization.  By selecting the right intervention, organizational biologist will increase your understanding of the DNA of your organizations Culture.



MaryAnn Fox

Board Member - Maryann has extensive experience in the pharmaceutical and consumer healthcare industries, and is currently GMP Training Manager at Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.  She previously worked as a consultant to the pharma and biotech industries, and was also a Knowledge Management Analyst and Training Manager at GlaxoSmithKline.  Areas of expertise include Training Strategy, Learning Management System implementation, Instructional Design  and Curriculum Design.  She has a special interest in Root Cause Analysis attributed to Human Error,  and Training Effectiveness.  Maryann has a M.S. in Pharmaceutics: Quality Assurance / Regulatory Affairs from Temple University, and a B.H.S. in Clinical Microbiology from Gwynedd-Mercy College. 

 

Bill Beyer

Managing Director for the Life Science Training Institute (LSTI)


Board Member at Large - Bill  is a business-builder, educator, and fan of all things that help others advance their careers.  As founder and Managing Director of the Life Science Training Institute (LSTI), he has overseen the training of over 25,000 pharmaceutical, medical device, and biotech personnel over the last four years.  Prior to founding LSTI, Bill was Marketing Director for the Center for Professional Innovation & Education (CfPIE).  During his time there, Bill developed eight industry-recognized certification programs spanning the GxP spectrum, and guided the company to significant revenue growth.  Earlier in his career, Bill held sales management positions with Learning Tree International and FDAnews.  Bill also spent five years with The Princeton Review, a leading standardized test preparation company.  As the Director of Graduate Programs, Bill developed Princeton Review’s MCAT verbal and USMLE Step 1 & 2 preparation courses.

Bill has a BS in Biological and Cultural Anthropology from Hartwick College in Oneonta, NY.  When he is not running LSTI, Bill likes to spend quality time with his family and is a horrible fisherman.


 

John Clifton

Director of Research Access for Industry Standard Research

Board Member at Large - John Clifton comes to us with over 20 years’ experience in the Life Sciences Industry.  John’s current role is Director of Research Access for Industry Standard Research.  A research firm specializing in syndicated research reports on GXP related topics.  John has also held positions as Director of Training Development for Life Science Training Institute and Vice President of Publishing for Vertmarket’s Life Sciences division.  John has a deep passion for helping people through learning and development.  John is well connected within the Life Science industry and utilizes his connections to help others with their business challenges.  John is consistently recognized for his energized can-do management style and enduring level of tenacity to get the job done.  John lives in Erie, PA and is a graduate of West Virginia University.

 

 

Michelle Durcholz




Michelle Durcholz

Quality Documentation & Training Manager

Bristol-Myers Squibb Co.

Board Member at Large – Michelle has been the Manager of Documentation and Training at the Hopewell site of  BMS for 6 years.  She previously held training roles at the New Providence, NJ and Bloomington, IN locations of Baxter Healthcare.  In her current role, she manages the documentation, training, audit support, and records management functions for the clinical manufacturing, GXP laboratories, and quality groups at the Hopewell location.  Her 16 years of experience in pharma has included roles in both Quality and Human Resources; both areas provided exposure to a broad range of information and processes.  Michelle’s areas of expertise include the Usage of Learning Managements Systems & Document Management Systems, Audit Readiness & Support, and Training Program Support.  She is currently a co-lead for the BMS Global Product Development and Supply Learning Community of Practice and strives to standardize, streamline, and lean out quality training processes across the organization.  Michelle enjoys spending time with her family & researching topics of interest.  She is a graduate of the University of Evansville.

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