Clients and colleagues recommend
Michelle Paganini...


On Michelle's presentation "Train the Trainer":
"I worked with Michelle on a "Train the Trainer" cGMP program. She is a very effective communicator with a real sense of how to engage a group of seasoned professionals. I've known Michelle for several years and would recommend her highly for any cGMP/ISO quality systems training or training materials development."
     -- Richard Love, Senior Director Quality Systems, Stiefel

On Michelle's presentation at the PDA Bienniel Trainsers Conference:
At the PDA Bienniel Trainers Conference in May 2006, Michelle's presentation "Quality Systems Approach to GMP" elicited the following comments:

• "Great interactions: got us thinking, engaged and awake."
• "Michelle is a very good trainer - she is engaging! Very enteraining, thought provoking and both understands as well as uses adult learning techniques.
• "This was a very good session - you love what you do and it really shows. I like the activities, they made us think but also let us feel like we knew what the answers were."
• "The use of exercises was very appropriate."
• "Excellent presentation, short and to the point."

Speaker's scores were tabulated, and while the average score for all speakers and sessions was 7.922, Michelle's presentation content and skills earned 8.494!
     

On training materials:
"The training materials Michelle developed and delivered in the area were thoroughly researched and well organized, both critical attributes for keeping our workforce up-to-date in a highly regulated field. These materials and the training itself were a key element of a successful regulatory inspection which followed the training."
      -- Frank Matarrese, Sr. Director
         Corporate Regulatory Compliance, Chiron Corporation, Emeryville, CA


On expertise:

“Michelle uniquely combines practicality with a thorough knowledge of regulatory requirements. Good common sense and knowledge are trademarks of her work. She makes it profitable to work with her.”

      -- Richard H. Davis, Jr., PhD, RAC, Director QA, Biosite Inc., San Diego, CA


On working style:
Michelle Paganini is a professional who gets the job done right the first time. Michelle works diligently
to understand the needs of her clients, and then turns those needs into a deliverable of which she and
the client are both proud. In addition to providing quality training materials and consulting, she is easy
and fun to work with. Michelle claims her goal is to make my job easier, and she does exactly that!”

      
-- Lina Divitt, Associate Director,
          Corporate Compliance Education and Development, Chiron Corporation, Emeryville, CA

On breadth of knowledge:

"As a young company with limited resources, we needed to turn to someone to help us with internal
quality audits and vendor audits. Our regulatory affairs consultant recommended Michelle to us and
we were not disappointed. We learned a tremendous amount from Michelle over the last few months
and this knowledge gave us the confidence we needed to undergo our first state FDA inspection.
If you work for a small company and you're looking for someone to help with quality system development,
analysis, or auditing in preparation for a government inspection, I would highly recommend Michelle.”

      -- Christopher Daniel, Senior R&D Manager, Rubicor Medical, Inc., Redwood City, CA

On presentation skills:
“Michelle is an excellent trainer. She is passionate about training and it shows! Michelle is able to
bring life to regulatory topics. Her audience enjoys her creative style, and her training message is
readily received and retained. I enjoy working with her and attending her training classes.”

      -- Diane Brooks-Smith, Director Regulatory Compliance, Becton Dickinson
         Biosciences, San Jose CA

On professional skills:
“Michelle is a great asset to any company. She is very dedicated, professional, and well versed in
her field. Because of her dedication to excellence, Metrika, Inc. passed the state FDA audit the
first time with no non-conformances”.

      -- Mark A. Scratch, Senior Manufacturing Manager, Metrika, Inc., Sunnyvale, CA

“The Quality Systems training materials Michelle developed were right on target. They are fresh,
approachable, and provide a foundation for procedure understanding, commitment, and process
improvement.”

      -- Andrew B. Morozovsky, Vice President of Regulatory and Compliance,
         Microgenics Corporation, Fremont, CA

"Seldom have I worked with someone so professional and enthusiastic as Michelle. She not only
did a great job for us, she made it all fun. I did not look forward to developing a system workshop,
as I knew the task would be difficult. Michelle not only developed the workshop in the best
manner possible, but also in record time."

    -- Scott Krumland, Subject Matter Expert, Validation,
        Chiron Corporation

“Michelle is a true professional. Not only is she an exemplary resource for professional guidance,
she is also as an enthusiastic, helpful, and sincere partner and colleague.”

      -- Robert E. Tricca, Director of R&D, Align Technology Inc., Santa Clara, CA