Working with industry and company professionals, 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 expert witnesses in support of dispositive motions and Daubert motions to exclude expert testimony.