Thomas "TJ" Woody
Thomas “TJ” Woody heads the Cleaning and Process Validation group at Integrated Project Services (IPS). TJ has over 27 years in the biopharmaceutical and pharmaceutical industries. His unique perspective is driven from his varied experience working for large and small companies in validation and operations. This experience includes managing and executing all aspects of a cleaning validation program and defending it routinely before regulatory agencies.
At IPS, his passion is assisting clients in identifying gaps and working together with them to develop workable compliant solutions. He is not a consultant that lectures as a living, but one that has battle-scars from real life experiences executing cleaning validation. TJ holds a bachelor’s degree in chemistry from Millersville University and is a Certified Quality Auditor through the American Society for Quality (ASQ).
Erich Bozenhardt has 11 years of experience in the biotechnology and aseptic processing business and has led several biological manufacturing projects, including cell therapies, mammalian cell culture, and novel delivery systems.
David Kane, with over 20 years in the field of technology, is the CEO of Ethical Intruder, a Pittsburgh based Cyber Security firm and focuses on Cyber Security related to software products.
Expertise includes trial management, protocol writing, clinical development plans, vendor management, vendor assessment and issue resolution, gap analysis, program management, regulatory submissions and SOP writing.
Experience in global operations, technical management, strategic planning, implementation of environmental health and safety programs, regulatory compliance and engineering support in a Fortune 200 setting.
Managing Partner at Widler & Schiemann Ltd, focusing on all aspects of clinical development from Protocol Quality by Design to Study set-up, Project Management and Risk-based oversight of Clinical Trials.
Specializes in the risk-based monitoring of pediatric and adult pharmaceutical, biologic and medical device clinical trials, in compliance and data management auditing and in training and education.
Expertise includes country and site selection principles, acceleration of site initiation, technology implementation and supplemental recruitment support.
Experience spans large and small molecule development and has played pivotal roles in designing novel ways to screen compounds for safety, resulting in several marketed products.
30+ years of GMP, GLP, and GCP quality assurance and compliance experience with Active Pharmaceutical Ingredients (APIs), clinical research materials, and finished product.
Specialties include emerging company clinical research management and training, curriculum development, change management, CGP, and project management oversight.
Mark Allen Durivage
Lead on-site quality inspections at facilities throughout the North America, Europe, and Asia for a $4.5B manufacturer of orthopedic products and instruments.
Christina Meyer Dell Cioppia
Has assisted biopharma, vaccine, pharma, and aseptic processing firms worldwide in commissioning, qualification, validation, design reviews, cGMP audits, and worldwide regulatory compliance.
Focused on regulatory strategy for novel products and applications, products intended to meet unmet healthcare needs, and projects involving vulnerable populations.
Specializes in providing regulatory and organizational strategy support, process improvement, inspection readiness support, and integration and harmonization of SOPs for medical device and pharma companies.
Diverse therapeutic experience background includes cardiology, neuromodulation, asthma/allergy, Duchenne muscular dystrophy, hereditary hemophilia and diabetes.
Experience with large scale initiatives such as assessments and implementation of organizational data integrity and compliance frameworks and responses to FDA warning letters and consent decrees.
Extensive knowledge and experience in the application of FDA law, regulations, and policy, particularly as it relates to compliance and enforcement programs and strategy.
Helped over 300 companies and organizations from Fortune 100 to entrepreneurial companies develop leadership, corporate turnarounds, team building and managing change.
Experienced in manufacturing technologies producing aseptic and terminally-sterilized parenteral API and finished drug products, solid and liquid oral products, inhalation drugs, and radiopharmaceuticals.
Herman Bozenhardt has 40 years of experience in pharmaceutical, biotechnology, and medical device manufacturing, engineering, and compliance.
Focuses on operations management for small manufacturing companies, including quality assurance, quality management, production planning, inventory management, and health/safety.
Founded e-SubmissionsSolutions.com to advisecompanies on the use of tech to manage regulatory and controlled documents and publish electronic submissions and registrations.