Dear Sir or Madam:
Please accept this letter as a statement of recommendation for Ken Woychesko and his staff at Tanis Technical Inc.
Until recently I was the Validation Manager at Taro Pharmaceuticals in Haifa, Israel, a multi-national pharmaceutical corporation. We contracted out the validation of some of our complex systems to Mr. Woychesko when we found ourselves short-staffed with some regulatory deadlines looming and the need for a validation contractor with North American experience.
Mr. Woychesko and his staff were quick to develop the protocols and other documentation required, and at times he visited the factories where our equipment was being built in order to produce accurate documents that met our strict timelines. During these manufacturer visits, he was also our "eye" on-site, ensuring that the equipment met our high quality standards.
During the execution phase of the validation, Mr. Woychesko remained on-site at our plant in Haifa for several months, overseeing, directing and organizing the engineers to ensure that the execution was performed smoothly and logically. At a subsequent FDA inspection, the results of the validation were reviewed and no issues were found.
As I am now Director of Quality Assurance & Regulatory Affairs at BioShaf Ltd. in Haifa, Israel, I would not hesitate to call upon Tanis Technical Inc. when we require outside validation resources again.
Regards,
Danny Seagull
Validation Manager
BioShaf Ltd.
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