B106 - ISO 13485:2016 & Related Standard Requirements 

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Instructor Thomas Lypka

Instructor Bio

• Thomas Lypka is the CEO of TSL Quality Inc., a Consulting Co. specializing in developing and/or managing all phases of engineering, manufacturing, compliance, regulatory and quality, management organization and training assignments specifically focusing on US FDA, EU MDD and Canadian CMDR regulated industries and sterilization validations for both product and processes. Projects include implementing and certifying ISO 13485 and ISO 9000 quality systems, building and certifying all classes of CERs & Clean Rooms, preparing and submitting successful 510(K) & Tech Files, and assisting companies dealing with FDA inspections and Registrar audits, recalls and FDA Warning Letters. Mr. Lypka is also a product, process, and internal combustion engine/machine senior designer holding various patents in these areas. Before becoming CEO of TSL Quality Inc., Thomas held positions of VP, Director and Head of QA, RA and Compliance for a variety of Bay Area companies since 1982. 

• Mr. Lypka has successfully certified 2 ISO 9000 and 5 ISO 13485:2003 quality systems which included 17 successful FDA inspections to the FDA QSRs. Mr. Lypka also built/certified 5 ISO Class 8 CERs to ISO 14644 which included training sessions for FDA inspectors for methods of inspecting CER certification. Additionally, he has implemented 5 JIT/Demand Flow process systems each realizing extensive cost, time and manpower savings and numerous product and process quality improvements. 
  
  
• As Head of Sterilization Development and Research for Abbott Labs, Mr. Lypka built and certified a sterilization process development Lab where he validated all sterilization processes for SVP and LVP rigid, semi-rigid containers and flexible bags including several continuous product sterilization processes. This included specifying and validating processes for each product using ETO, UV, Flame, Dry Heat, Steam, Water Overspray, gamma radiation and micro pore filtration methods. 

• As head of R&D, Engineering, Manufacturing and Quality for ACS, Mr. Lypka designed and developed PTCA devices which were implemented using Learning Curve Theory combined with Japanese manufacturing and Quality techniques such as TQM and World Class Quality. 

• As head of Clinical Trials Quality for Syntex Corp., Mr. Lypka developed the only ISO 9000 compliant Clinical Study Trials quality system realizing tremendous time and cost savings in the drug development process. This documentation was transferred and taught to FDA to monitor and detect clinical trial issues including the detection of fraud in clinical study trials. 

• Mr. Lypka was instrumental in developing sterilization validation methodologies for E-Beam sterilized product and served as the Head of Quality for Nutek Corp, an E-Beam facility. 
  
  
• Thomas has been a member of ASQ since 1983, and was vice chair of the biomedical division in 1988 - 1989. During this period, Thomas was speaker at numerous conferences speaking on quality improvement and Pre Production Quality Assurance (PQA) the precursor to the current FDA and ISO mandated Design Control. 

• Thomas received his formal quality training from D’Anza College in Cupertino, CA, is RAPS Certified, and a member of ASQ, RAPS & DIA and other organizations.

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Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.

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