Avoiding Common Pitfalls During FDA Inspections

 Simona Mills, PMP, is the Sr. Director of Product Lifecycle Management in the Quality and Compliance service line at ProPharma. She has more than 23 years of industry experience in pharmaceuticals, biologics, and combination products. Simona previously worked for a CMO with its own generics line of parenteral products before joining ProPharma. Her expertise is in Quality (Validation, Quality, Quality Engineering, and Regulatory Affairs) and Project Management, with additional experience in facility construction/start-up, remediation, and people and project management. Since joining ProPharma, Simona has earned her PMP certification and has worked on a variety of projects, including Tech Transfer, Compliance/QMS, Inspection Readiness, Remediation, 505(b)(2) commercialization, Auditing, etc. She established and leads the Inspection Readiness/PAI Readiness services at ProPharma.   Simona Mills studied Chemical Engineering at The Ohio State University. 

Dr. Eric Good is an energetic, award-winning leader with extensive domestic U.S. and international organizations. For the past 10 years, Dr. Good has been a Compliance & Quality Director at ProPharma Group. Prior to joining ProPharma, Dr. Good spent 25 years in Aseptic Manufacturing, Project Management and Quality Assurance in many Fortune 500 companies. His strengths include quality systems integration and implementation, process improvement, and cross-functional working relationships. In addition to serving as Adjunct Faculty for University of Maine Systems, he has also been an Adjunct Faculty at the University of Phoenix teaching in the Business programs. 

As Associate Director, Product Lifecycle Manager, Quality & Compliance, at ProPharma, Eric leads and guides global programs and interdisciplinary teams in the late-stage development, inspection readiness and commercialization lifecycle phases. Eric’s extensive project management experience encompasses programs in the immunology, oncology, ophthalmology, respiratory, infectious, and rare disease therapeutic areas. His career span includes delivering medical device, genomic research, and diagnostics programs as well as GxP system implementations. Additionally, Eric leverages his career knowledge and expertise building Project Management Offices, providing best-in-class project governance models and operational standards to accommodate unique organizational needs. Eric received his bachelor’s degree in industrial engineering technology from East Carolina University and has been a PMP-certified project manager since 2004. Eric has more than 25 years of Life Science industry experience, including 5 years in biologics, 7 years in cell therapy and 14 in medical and combination devices.

Kalie Richardson is an attorney at Hyman, Phelps & McNamara who advises clients across the industry on FDA regulatory compliance and enforcement.  She has a particular interest in inspection readiness and has recently participated in FDA for-cause and surveillance inspections of drug and device manufacturer clients. Kalie regularly assists with FDA Form 483 and warning letter responses, post-inspection remediation, and internal investigations. She also advises manufacturers, wholesale distributors, and 3PLs on compliance with the Drug Supply Chain Security Act, Controlled Substance Act, and state licensing requirements.