July 5, 2020

Volume X, Number 187

Theodore M. Lis

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 manufacturers in more than a dozen countries that produce API, aseptic injectables, biologics, combination products, ophthalmics, oral solid doses, medical devices and vaccines.

Working with industry and company experts, Ted applies his broad experience to advise Quality and Manufacturing managers 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 inspectors’ requests.

The following examples represent the types of issues with which Ted has assisted clients in managing and presenting to regulators:

  • 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.

In addition to GMP and QS regulation enforcement work, Ted is an experienced litigator. He has represented pharmaceutical companies when deposing plaintiffs, physicians and experts in support of dispositive motions and Daubert motions to exclude expert testimony.

Articles in the National Law Review database by Theodore M. Lis

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