Meet Our Instructor: Judy Carmody, Ph.D., of Analytical Method Validation

With over 25 years of experience in the (bio)pharmaceutical industry, Dr. Judy Carmody has a unique approach to developing solutions for Quality or Analytical issues. Her history in the industry includes marketing, applied technology, validation, quality management, bench chemistry, and a variety of leadership roles – including acting as the founder and president of the GMP CRO Avatar Pharmaceutical Services.

Dr. Carmody’s Start in the GMP Field

Dr. Carmody earned her Ph.D. in Analytical Chemistry from Clark University in Worcester, Massachusetts. Since then, she has developed a reputation as someone that creatively integrates technologies from diverse fields to solve common client problems. For example, when she worked at Waters Corporation’s Applied Technology and Marketing groups, she was responsible for developing innovative separation methods that were presented around the world and to leading (bio)pharmaceutical companies. During her time at Waters, Dr. Carmody brought many new technologies to market through published papers and technical presentations.

Founding Avatar Pharmaceutical Services

After ten years working in the (bio)pharmaceutical field, Dr. Carmody founded Avatar Pharmaceutical Services. She led the company for nearly another decade, before selling it and moving on to a variety of senior-level positions in both large and small pharma companies. This has given her an excellent and in-depth understanding of quality systems as they apply to every corner of the (bio)pharmaceutical world.

Custom-Crafted Solutions

Dr. Carmody is known for finding the bridge between regulatory processes needed for quality control, and the strategic and marketing needs of a corporation. Her consulting service, Carmody Quality Solutions, LLC., is one of the most trusted consulting agencies in the medical device industry, the biologics industry, and the pharmaceutical industry. She combines her understanding of analytical chemistry and validation with leadership, marketing, and applied technology to truly create well-rounded solutions for common industry issues.

Courses Taught by Dr. Carmody

Dr. Carmody now teaches the Analytical Method for Biologics, Biopharmaceuticals, and Other Therapeutic Products at CfPIE. This course provides a very comprehensive overview of regulatory authority requirements across the globe. Dr. Carmody teaches supervisors, auditors, managers, and those who perform the regulatory processes. Although the subject matter can be very complex, students report that Dr. Carmody makes the material easy to understand, and is very knowledgeable when answering questions. Her passion for creating innovative solutions in the industry translates to a passion for helping all students find a way to understand the material.

What Dr. Carmody Brings to CfPIE

Through Dr. Carmody’s instruction, students leave their course with a very thorough understanding of international regulatory processes, an understanding of how to plan and execute test method programs, how to write test method validation protocols, and how to avoid mistakes that are commonly made in the validation process. Because the course relies on case examples that are based on real-life biologic product testing, Dr. Carmody’s extensive background in (bio)pharmaceutical production makes her uniquely qualified to lead this course. Her specialties in both regulatory and management procedures are passed on to CfPIE students through this course.