FDA Audit Checklist Clinical Trials Seminar 2018

FDA Audit Checklist Clinical Trials Seminar 2018
Event on 2018-04-26 09:00:00
Course "Managing Your FDA Inspection: Before, During and After" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. The course will let you see inside an FDA investigator's mind set and what the agency will do when it evaluates what the investigator says and documents. What the investigator does and what FDA does are not mysteries, they just seem like it. Why you should attend: "Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol. You think, "Why is FDA here? Are we in trouble?" Are you prepared to talk about the trouble you know you have with FDA regulations or is your plan of action to cross your fingers. We all know that a bad FDA inspection has immediate and long-term consequences. The cost of fixing your problems, the bad public relations, upset customers and future business plans can be set into a downward spiral. If you do not understand what FDA is doing or thinking, how can you expect to deal successfully with FDA? If you don't know how to anticipate an investigator's actions or follow their train of thought, you will not be able to mitigate the effect of inspectional findings. "Is FDA going to send us a Warning Letter?" You can make a reasonable prediction if you understand your inspectional results and how FDA will "grade" it. The tools are available. Areas Covered in the Session FDA legal authorityTypes of inspectionsFDA investigator trainingFDA's written procedures, policy and operations guideIndustry inspection protocolWhat to do and not do during an inspectionForm FDA 483 responseWarning Letter responseEnforcement Who Will Benefit: Regulatory AffairsQuality AssuranceManufacturing Agenda: Day 1 Schedule Lecture 1: FDA Inspection authority FDA Inspection authorityInspectional refusal prohibition Lecture 2: Types of Inspections: purpose, scope and scrutiny Comprehensive GMPAbbreviated GMPDistrict or Center DirectedRegulatory Follow-upSurveillanceLimitedFor Cause Lecture 3: Impact on you during and after inspection How to interact with the FDA investigatorWhat not to say and doYour protocolMismanagement of the inspection Lecture 4: FDA Investigator Training – This is what they are thinking On the job training and supervisionTechnical, classroom and mock inspectionsEvidence development to tell the storyPhysical and documentary samples of your violationsWriting reports, inspectional observations and sample documentationPhysical threats and assault Lecture 5: Investigations Operations Manual Procedures and technical guidance. FDA's rules for themselvesFDA organization chart "in the field." Who is watching you? Compliance Programs Section III – the inspection / specific issuesSection V – the regulatory response / risk assessment Lecture 6: Investigations Operations Manual (continued) Writing inspectional observations (Form FDA 483)Writing establishment inspection reportsEvidence documentation and custody Mock "Limited" inspection Day 2 Schedule Lecture 1: FDA Form 483 – List of objectionable conditions, aka list of observations PurposeFormat / organizationManaging 483 observations during the inspectionResponding to 483 observations during "discussion with management" What it meansHow to manage the discussionHow to challenge a 483 observationWhat to say and not say Lecture 2: Your written response to a 483 Understanding the 483 – using an FDA issued 483Time deadlinesStrategy for corrections and corrective actionEvidence of corrections and corrective actionEmpty promises Lecture 3: FDA Warning Letter – advisory of possible legal action FDA Warning Letter proceduresResponding to a Warning Letter – in 15 working days. Group Hypothetical Warning Letter Response – in 10 minutes Lecture 4: FDA Enforcement Actions Judicial SeizureInjunctionProsecutionMonetary penalties Administrative Import / ExportGovernment contractsOther government agency advisoriesFinesPremarket holds Speaker Casper Uldriks ex-FDA Expert and former Associate Center Director of CDRH Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Location: Seattle, WA Date: April 26th & 27th, 2018 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA Price: Register now and save 0. (Early Bird) Price: ,295.00 (Seminar Fee for One Delegate) Until March 10, Early Bird Price: ,295.00 From March 11 to April 24, Regular Price: ,495.00 Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)* Register for 10 attendees Price: ,122.00 ,950.00 You Save: ,828.00 (45%)* Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- https://www.globalcompliancepanel.com/control/sponsorship Contact us today! NetZealous LLC DBA GlobalCompliancePanel john.robinson@globalcompliancepanel.com support@globalcompliancepanel.com Toll free: +1-800-447-9407 Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com Registration Link Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/ Follow us on Twitter: https://twitter.com/GCPanel Early Bird – Seminar Fee for One Delegate – 95.00 Regular Price – 95.00 Register for 5 attendees – 85.00 Register for 10 attendees – 22.00

at Courtyard Seattle Sea-Tac Area
16038 West Valley Highway Tukwila Washington 98188 USA
Seattle, United States

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