PPT-Self-Inspection / Assessment Preparation

December 2013 Michael Campbell ViaSat Inc NISPOM Requirements Interpretation Category Level Business Best Practices Available Tools PreInspection SelfInspection PostInspection Communication. COLIN RICHARDS. NUT NATIONAL EDUCATION CONFERENCE. 2013. The sharp end of inspection. The secret thoughts of a teacher about to be inspected. Three odd letters.  . If . Chris . Huhne. . pleaded guilty to perverting the course of justice, shouldn't Michael Wilshaw plead guilty to perverting the course of inspection?. National Accreditation Body in the UK. Self-funding private company limited by guarantee (Non-profit distributing). 180 full time staff (70% technical). Pool of 250 technical assessors (contract). Operating in the public interest. Tank . Inspection Intervals. Presented by: Mark A. Baker, P.E.. . Baker Consulting Group, Inc.. Inspection Frequency Considerations. a) the nature of the product stored;. b) the results of visual maintenance checks;. Temperature/humidity restrictions often ignored. Air and surface temperature can be too hot or too cold for proper film formation and curing. Relative humidity can be too high for proper curing (and for moisture curing products, too low). Group 3 – LIQUID HARMONY. MODULE CONTEXT. Audience: . New and experienced IACUC Members performing facility inspections.. GOALS: . IACUC . should be able to properly conduct a facility inspection. . For . Highway Network Safety . 1. . . Presented by Herby G. Lissade, P.E.. Chief, Office of Emergency Management. . California Department of Transportation. . Danielle Fagnan, . pharmacist. ,M. Sc.. . Director. of . professional. services. Ordre des pharmaciens du Québec. NAPRA March 13. ,. 2014. Standards for pharmacy compounded sterile preparations. Presentation to SAGMA Workshop. 15 August 2016 . Presentation Outline . Brief Background. Terms of Reference . Objectives of the Collaborative procedure . Progress . ZAZIBONA Process . The Future . Brief Background . for Pre-Approval . Inspection . PHARMACEUTICAL INDUSTRY. Client . . A. l. arge pharmaceutical company contracted with a. . new . Korean . biologics Contract Manufacturing Organization (CMO) facility to manufacture their products.. SHEDDING LIGHT ON AN FDA VISIT Joyce Nancarrow Tull, MSN, RN, CCRP University of Southern California USC Norris Comprehensive Cancer Center Clinical Investigations Support Office DISCLOSURES I have no financial disclosures Joyce Nancarrow Tull, MSN, RN, CCRP. University of Southern California. USC Norris Comprehensive Cancer Center. Clinical Investigations Support Office. DISCLOSURES. I have no financial disclosures. I have been through four (4) FDA visits and met three different FDA Inspectors for IND approval; this does not make me an expert, just somewhat of a survivor. I am willing to talk with you about what I learned and encourage for you to join me in sharing experiences.. Associate Director. Quality Improvement Office. Office of Research Compliance. Federal Agency Audit. Conducted by FDA, Office of Human Research Protections, Office of Research Oversight, etc. . FDA most commonly performs Routine Inspections as part of the approval process for drugs or devices but can also audit For Cause.. Malaysia. 1. OBJECTIVE . 2. To review the activities in preparation for a GMP inspection. Where & How Do We Start a GMP Inspection?. . GMP INSPECTION PREPARATION. 3. Generally the processes involve;. Malaysia & Indonesia. 1. OBJECTIVE . 2. To review the activities after GMP inspection.. POST-INSPECTION. 3. Definition of deficiencies. Inspection report format. Inspection report details. Inspection report distribution.