Maxine K. Fritz is Executive Vice President of the Pharmaceutical and Biologics Practice at Becker & Associates Consulting, Inc. (Becker™ Consulting).  Ms. Fritz is a former FDA investigator who specialized in biological and pharmaceutical product inspections and served as the Biologics Team Leader.  Ms. Fritz has 23 years of combined FDA/industry management experience, including a variety of pharmaceutical quality activities such as quality assurance senior management, validation, vendor qualification, internal/external audits, batch record review, product release, investigation of non-conformances, current Good Manufacturing Practices (cGMP) training, and aseptic manufacturing.  This unique combination of experience allows her to provide clients with strategic, tactical, and technical advice to assist them developing practical quality assurance, manufacturing, and regulatory strategies for compliance with FDA regulations.  

Elaine C. Messa is Executive Vice President of the Medical Device Practice at Becker & Associates Consulting, Inc. (Becker™ Consulting).  Ms. Messa began her career at FDA, where she worked for 30 years.  Her most recent position at the Agency was as Director of the Los Angeles District, which is responsible for the largest import operations and medical device workload in the US.  During her FDA tenure, she successfully established an industry grassroots group, developed technical  training efforts with local regulatory associations, and participated in the development and implementation of regulations, guidance, policy, and compliance programs. As a result of this work she received two FDA Awards.  Ms. Messa now works with clients in the medical device, pharmaceutical, and biotechnology industries to develop quality assurance, manufacturing, and regulatory strategies for compliance with FDA regulations.  Ms. Messa has a proven record with successful management and resolution of FDA Warning Letters, Import Detentions, Consent Decrees, and other regulatory actions.

Harold "Wally" Pellerite serves as a Director, Medical Devices on the Expert Advisory Committee at Becker & Associates Consulting, Inc. (Becker Consulting).  He is the former Director of Strategic Compliance at Quintiles Consulting in Maryland, where he applied his significant experience with regulatory requirements for medical devices and experience in evaluating and resolving compliance and enforcement issues.  From his 30 year career within FDA’s Center for Devices and Radiological Health (CDRH), Mr. Pellerite has an extensive historical knowledge of FDA enforcement strategies, policies, and actions.  He works with clients to develop and execute cost-effective gap analyses and corrective action plans in response to FDA 483s, Warning Letters, and other regulatory actions.  He is recognized as an expert in the Medical Device area and has served as an expert witness in numerous civil cases.  

During his three decades of CDRH experience, Mr. Pellerite spent 20 years as the Assistant to the Director, Office of Compliance (OC).  He also served as a Senior Advisor to the Office and to Center Directors and was the initial contact for compliance and enforcement issues for FDA field offices, legal counsel, corporate executives, and international executives from the private and government sector.   His main areas of expertise include Medical Device Reporting (per 21 CFR 803), complaint handling, and Corrective and Preventive Actions (CAPAs).  Mr. Pellerite also trained FDA staff on labeling requirements (per 21 CFR 801) and evaluating off-label use.   

As a Director on Becker Consulting's Expert Advisory Committee, Wally helps guide the development of the firm’s medical device compliance practice in addition to providing technical consulting solutions for clients.

Tim Ulatowski serves as a Director, Medical Devices on the Becker & Associates Consulting, Inc. (Becker Consulting) Expert Advisory Committee.  Mr. Ulatowski has over 36 years of public health experience, including more than 25 years in leadership positions at FDA’s Center for Devices and Radiological Health (CDRH).  He most recently served as Director of the Office of Compliance at the CDRH, where he managed and supervised four divisions and 180 professional staff responsible for ensuring compliance with medical device laws and regulations.  Mr. Ulatowski has also served as a primary reviewer on numerous 510(k)s, IDEs and PMAs, and he managed premarket activities as Director of the Division of Dental, Anesthesiology, General Hospital, and Infection Control Devices at CDRH’s Office of Device Evaluation (ODE).   

In addition to extensive FDA experience, Mr. Ulatowski has proven expertise advising industry on regulatory issues, assessing compliance and enforcement actions, evaluating premarket documents, collaborating with stakeholders with diverse interests, and resolving complex technical and scientific problems.  As a Director with Becker Consulting’s Expert Advisory Committee, Mr. Ulatowski helps guide the development of the firm’s medical device practice in addition to providing tailored technical consulting solutions for clients.