Join us for an engaging and dynamic dinner meeting to discuss topics focused on the Oversight of Drug Quality and Post-Approval Improvements: Quality Metrics and Root Cause Analysis. The agenda includes two presentations from senior management professionals providing the following:
- An overview of quality metrics followed by case studies of the impact of quality metrics on inspections
- Corrective Actions and Preventive Actions (CAPA) and root actual cause analysis used for investigating nonconformities identified during drug manufacture
5:00PM Registration, Cocktails and Newtorking
7:00PM 1st Presentation: Measure for Measure: Quality Metrics
Felica Ford-Rice, Director Strategic Compliance, PAREXEL International
7:45PM 2nd Presentation: Getting "Good at Failure" - A CAPA Perspective
Troy Fugate, VP Compliance Insight Inc.
Measure for Measure: Quality Metrics, Felicia Ford-Rice, Director, Strategic Compliance, PAREXEL International
Robust Quality Metrics are a key component of the Quality Management System in developing Drugs, Biologics and Medical Devices. During this session we will discuss the quality metrics as (1) defined by regulatory authorities, (2) proposed by Professional Associations as well as a (3) review of case studies highlighting the pros and cons of the use of Quality Metrics and the impact on regulatory authority inspections.
Getting “Good at Failure” – A CAPA Perspective, Troy Fugate, Vice President, Compliance Insight, Inc.
Providing a brief introductory discussion on CAPA and what it means to FDA regulated industry, we will dive into case studies of problems encountered and how companies dealt with them – successfully and unsuccessfully.
Pricing is $55 for Members, $65 for Non-Members.
Vegetarian meals are available - please indicate your preference during registration.
About the Speakers
Felicia Ford-Rice, Director, Strategic Compliance Services, at PAREXEL Consulting
Utilizes over 25 years of R&D, Regulatory Affairs and Quality Assurance expertise to advise clients on the development, implementation and management of quality systems to ensure Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice and Pharmacovigilance compliance. Ms. Ford-Rice joined PAREXEL in 2010 and provides consulting services on a variety of quality compliance topics including:
- GxP Compliance/ Inspection Readiness / Training / Quality Metrics
- Regulatory Risk/ Data Integrity/Failure Investigation/ Change Control Evaluation
- Corrective Action and Preventive Action /Product Complaint Assessments
Ms. Ford-Rice consults with client senior management to develop effective strategies and responses to regulatory authority findings (e.g., FDA 483, Warning Letters, EMA and Health Canada Inspection Observations) and performs verification activities for enforcement sanctions (i.e., Warning Letters, Consent Decrees) and activities under attorney-client privilege. In addition, Ms. Ford-Rice performs systems-based assessments of sterile and non-sterile, API, pharmaceutical, radiopharmaceutical, and biological manufacturing operations. Prior to joining PAREXEL, Ms. Ford-Rice held senior positions in Quality Assurance for Astellas, Acambis (now Sanofi Pasteur), AtheroGenics Inc., Glaxo SmithKline / SmithKline Beecham and served as Adjunct Professor (Part-Time) for Northeastern University. Previously, she held roles in Research and Development and Regulatory Affairs for the National Institute on Drug Abuse, Johns Hopkins, Sterling Drug and Sanofi.
Ms. Ford-Rice has served on committees of multiple pharmaceutical industry organizations and presented on compliance topics at professional association meetings. Ms. Ford-Rice has taken coursework in pursuit of a Master of Science degree in Bioscience Regulatory Affairs at Johns Hopkins University. She earned a Master in Management in Business Administration and a Project Management Certificate from Penn State University, and a BS in Biology from Virginia Tech. Ms. Ford-Rice completed Management Development and Leadership Executive Education courses at Emory University, and holds a professional certification in Regulatory Affairs.
Troy Fugate, Vice President, Operations, at Compliance Insight
utilizes approximately 30 years of Quality Assurance, Validation, Compliance Development and Training skills to infuse GMPs into your organization’s DNA. Utilizing compelling GMP events to blend “insight” and “inspiration”, Mr. Fugate motivates clients on the enhancement and development of their quality systems. Mr. Fugate has been a partner in Compliance Insight since 2001 and serves in a variety of roles including:
- Strategic GMP compliance solutions
- FDA mitigation
- Compliance Assessment for Risk (CAR)
- Tactical growth and development with Complete MasteryTM
Compliance Insight is a unique compliance service provider for the pharmaceutical and medical device industries around the globe. Their uniqueness stems from their blend of three elements – Expertise, Options Orientation and The CI Codes. Their goal has been, and will always be, to provide value to any firm by offering simple, practical solutions in the areas of Quality, Regulatory and Clinical compliance.
Mr. Fugate developed the company focus of: Knowledge + Flexibility + Value and Ethics Centered Discipline = Effective and Comprehensive Compliance Solutions. He has engaged the process of “Align – Apply – Adapt” with firms in North America, Europe and Asia with great success.