Overview
Ted Lis entered the practice of law after nearly a decade as a chemical engineer for a major American chemical company and is a senior member of the American Institute of Chemical Engineers. He uses his legal and engineering training to improve his clients’ standing with FDA and other regulatory agencies with respect to Good Manufacturing Practice (GMP) and Quality System (QS) regulation. Over the course of his career, Ted has assisted manufacturing facilities in more than a dozen countries as they resolved GMP issues involving API, aseptic injectables, biologics, combination products, ophthalmic products, oral solid doses, medical devices and vaccines.
Working with industry and company professionals, Ted applies his broad experience to advise Quality and Manufacturing managers and senior executives who face critical issues that are the focus of regulators. He assists clients with managing communications with regulatory agencies, preparing for pending site inspections and training personnel. He also provides on-site support during inspections to assist subject-matter experts in cogently and succinctly presenting information that is relevant to investigators’ requests.
Ted has extensive experience in technical GMP and QS regulation issues, including:
- Data Integrity: assess risks to products based on retrospective data reviews; investigate and remediate data systems for laboratories and manufacturing processes.
- Aseptic Practice: evaluate and remediate environmental monitoring programs; develop disinfectant efficacy studies; execute and document robust media simulations; investigate sterility failures.
- Regulatory Communication: formulate action plans in response to inspection observations; respond to 483 observations and Warning Letters; draft periodic updates for regulators; advise agencies about manufacturing issues associated with drug shortages.
- Validation: evaluate and remediate API equipment cleaning validation; plan and execute automated and manual visual inspection validations for particulates and container defects; re-validate steam sterilization processes.
- Quality Systems: improve processes for FARs, BPDRs, complaints, investigations, change control and approved suppliers.
During the COVID-19 public health emergency, Ted has assisted clients in preparing Emergency Use Authorization applications and communicating with FDA for medical devices that include in vitro diagnostic tests, personal protective equipment and ventilators.
Ted also has experience in conducting internal investigations involving alleged FDA violations.
In addition to GMP and QS regulation enforcement work, Ted is an experienced litigator. He has represented pharmaceutical companies when deposing plaintiffs, physicians and expert witnesses in support of dispositive motions and Daubert motions to exclude expert testimony.
Services & Industries
Credentials
Bar Admissions
District of Columbia
Virginia
Court Admissions
U.S. Bankruptcy Court for the Eastern District of Virginia
U.S. District Court for the Eastern District of Virginia
Education
Georgetown University Law Center
J.D. (2002)
Drexel University
B.S. in Chemical Engineering, Engineering Honor Society (1990)
Insights & Events
Latest
Insights
Other Perspectives
- Data Integrity: FDA Expectations
Webinar, May 25, 2016
Leadership & Community
Professional Associations
- U.S. Technical Advisory Group — ISO/TC 209, Cleanrooms and Associated Controlled Environments, Convenor of Working Group 5 (Cleanroom Operations), 2020
- Parenteral Drug Association
- American Institute of Chemical Engineers — Senior Member
- International Society for Pharmaceutical Engineering (ISPE)