BME416-QualSys

BME416-QualSys - Quality Systems Quality Systems Enid Rokaw...

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Unformatted text preview: Quality Systems Quality Systems Enid Rokaw Regulatory Science Program USC School of Pharmacy rokawcar@usc.edu Why Me Why Me ? ? Im an engineer .... why do I need to know this regulatory stuff ? QUALITY As before, because As before, because Your work in product development will be subject to Design Controls (similar to QSR) Your work in manufacturing development will be subject to Quality Controls (=QSR) Your documents may be included in submissions to FDA You will entertain quality auditors before and after marketing approval You will have your own quality issues in the management of your department Quality Standards are regional Quality Standards are regional US: Quality Systems Regulations 21CFR 820 (QSR) EU: ISO 13485 Current attempts to harmonize incomplete Third party inspections allowed for certain products in Class I and II by FDA Accredited persons (i.e. certain companies) Eligible devices (i.e.specifically designated) Some Accredited Bodies in Some Accredited Bodies in U.S. U.S. British Standards Institution California Dept of Health Services Center for Measurement Standards for Industrial Cheiroon BV Citech Entela Inc. Interteck Testing Services Kema Quality BV NIOM - Scandinavian Institute of Dental Materials Regulatory Technology Services LLC TUV America TUV Rheinland of North America Inc. Underwriters Laboratories Inc. Where does Quality fit into a US Where does Quality fit into a US submissions/approval process? submissions/approval process? Submissions technical/manufacturing volume Facilities Processes and validations Design control Appendices Engineering descriptions and test plans Validations Other reports Preapproval Inspections Preapproval Inspections Expect this after lodging the submission during FDAs review Failure to pass inspection is a very common reason for delay of approval Does the FDA revisit when you Does the FDA revisit when you make changes? make changes? http://www.fda.gov/cdrh/comp/likehood. Sometimes Which changes might affect safety-efficacy? Which changes might affect safety-efficacy? 1.purchasing ( identical material from new source) 2.vendors of material, where specifications of the material are unchanged 3.the sterilization type or process parameters at the same facility, 4.a manual process to an automated process, 5.a "joining" process where the toxicological and biocompatibility properties of a new adhesive are well known, and not considered to be a potential problem, 6.a "joining" process where a different solvent or energy source is used to join the parts, 1. a cleaning method used to remove manufacturing material, 2. manufacturing materials, 3. clean room specifications, 4. a quality control test used to determine a specific attribute of an incoming component or raw material, the in process device or the finished device, 5. the type of process used (e.g., changing from machining a part to the type of process used (e....
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BME416-QualSys - Quality Systems Quality Systems Enid Rokaw...

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