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Consultants Update

Consultants Update. Tom Badstubner Medical Gases Consultant Gases & Welding Distributors Association June 20, 2011. Topics for Discussion. FDA Draft Guidance USP update Electronic Registration Food Regulations/Inspections State Regulations/Enforcement Training

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Consultants Update

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  1. Consultants Update Tom Badstubner Medical Gases Consultant Gases & Welding Distributors Association June 20, 2011 GAWDA Consultant's Forum Webinar

  2. Topics for Discussion • FDA Draft Guidance • USP update • Electronic Registration • Food Regulations/Inspections • State Regulations/Enforcement • Training • FDA Enforcement/Transparency GAWDA Consultant's Forum Webinar

  3. Draft Guidance • FDA published in 2003 • Each year the FDA announces that they intend to publish the final guidance. • Credibility is low … they have made this same announcement many years since 2003 GAWDA Consultant's Forum Webinar

  4. USP Medical Gas Revisions • “For more than 50 years, USP has published monographs and general chapters in USP–NF to ensure the safety of medical gases. Soon USP will propose revisions to these monographs and general chapters. USP plans to publish the monograph revisions along with the new and updated general chapters in the Pharmacopeial Forum by early 2009. This set of updates has been in process through a variety of revision approaches since 2002 after the Food and Drug Administration (FDA) issued a public health advisory the previous year addressing deaths and injuries to patients resulting from medical gas errors.” GAWDA Consultant's Forum Webinar

  5. Electronic Registration • If you to register yourself, contact AsteRisk for the procedures. • Do the “Listing” after the “Registration” • The “listing” documents the products, cylinders, purities and labels. (~Form 2657) GAWDA Consultant's Forum Webinar

  6. Electronic Registration • Check your registration at: • http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm • Check your listing at: • http://dailymed.nlm.nih.gov/dailymed/search.cfm GAWDA Consultant's Forum Webinar

  7. Food • Food Safety Modernization Act (2010) • Registration • Inspections • Enhanced recall authority • No regulations or guidance yet • Safe Food Transportation Act (2007) • Designed to prevent food contamination • No regulations or guidance yet GAWDA Consultant's Forum Webinar

  8. Food • Customer Initiatives • ISO 22000 – Food Safety Management System • Draft Food Gas Procedures GAWDA Consultant's Forum Webinar

  9. FDA Food Warehouse InspectionFDA 2679 GAWDA Consultant's Forum Webinar

  10. State Regulations • Expiration Dates • Florida – must use expiration dates • Texas – must not use expiration dates • Texas – N2O security • Significant license enforcement - FL • “Keep out of reach of children” – FL • Label specimen on the fill log – CA • CO/N2O Prop 65 Label in CA • New GAWDA Medical Gas Compliance Alerts GAWDA Consultant's Forum Webinar

  11. Training – Drug CGMP • FDA Drug CGMP - Current Good Manufacturing Practices • 7/1/2011 CGMP - Process Validation for Cylinder Plants • 8/5/2011 Subpart G – Packaging and Labeling Control • 9/2/2011 CGMP –Filling High Pressure Cylinders • 10/7/2011 Subparts H & I – Holding and Distribution, Laboratory • 11/4/2011 CGMP - USP SOPs/OOS - Out of Specification • 12/2/2011 Subparts J & K – Records / Returned Drug Products GAWDA Consultant's Forum Webinar

  12. Training - Device QSR (& ISO) • FDA Device QSR - Quality System Regulations and ISO 17025 • 7/1/2011 QSR Subparts K, L & M - Handling, Storage, Distribution, Installation, Packaging and Labeling Control, Records • 8/5/2011 ISO 17025 - Measurement Traceability • 9/2/2011 QSR Subpart N, O and Part 803 – Servicing, Medical Device Reporting, Statistical Techniques • 10/7/2011 ISO 17025/QSR - Complaints, Non-Conformances, Corrective Action/Preventive Action (CAPA) • 11/4/2011 ISO 17025 - Internal Audits and Management Reviews • 12/2/2011 ISO 17025 - Propagation of Errors GAWDA Consultant's Forum Webinar

  13. Training – Specialty Gas • 7/1/2011 Making Highly Reliable Gravimetric Mixtures • 8/5/2011 Fuel/Oxidizer Safe Practices • 9/2/2011 Filling High Pressure Cylinders • 10/7/2011 Measuring and Controlling Uncertainty in Gas Chromatographs (ISO 6143) • 11/4/2011 Gas Chromatography Fundamentals • 12/2/2011 Gas Chromatography Column & Detector Selection/Troubleshooting GAWDA Consultant's Forum Webinar

  14. GAWDA Training Record GAWDA Consultant's Forum Webinar

  15. FDA Enforcement Actions • All Industries – 2010 • Seizures - 10 • Injunctions - 17 • Warning Letters - 673 • Recall Events - 3,799 • Recalled Products - 9,361 • Debarments – 13 • Medical Drug and Device Gases – very little action GAWDA Consultant's Forum Webinar

  16. FDA Transparency • Warning Letters 1997 – 2011 • http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm • Searchable by company, subject, etc • Inspections • http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#drugs • http://www.accessdata.fda.gov/scripts/inspsearch/ • 17635 inspections in 2010 – total GAWDA Consultant's Forum Webinar

  17. FDA Transparency • Inspections – Turbo EIR Reports • http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm#drugs • 17635 inspections in 2010 – total • 6695 From 483s • Download Inspection Results • http://www.fda.gov/ICECI/EnforcementActions/ucm250720.htm GAWDA Consultant's Forum Webinar

  18. FDA Transparency • Top Violations • Procedures not in writing, fully followed • SOPs not followed / documented • Investigations of discrepancies, failures GAWDA Consultant's Forum Webinar

  19. Contact Info Tom Badstubner • Office (508) 883-0927 • Cell (443)255-8984 • Fax (508) 883-3558 • Email tom@asteriskllc.com GAWDA Consultant's Forum Webinar

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