This course will present the regulations and guidelines that apply to the safety testing of medical products and also discuss the rules as they apply to testing laboratories that study samples derived from test animals or test subjects in clinical studies. The purpose of the course will be to instruct laboratory personnel in the material that they must know or prepare to pass an FDA inspection. The course will also discuss the types of studies that come under the GLP regulations.
Having trouble with this message? View it Online Follow us on social network +91 080 32014957 / +91 080 32473691 +91 080 26421483 Toll free: 1800 425 9409 firstname.lastname@example.org Download Seminar Brochure RAPS Approved. Earn 12 RAC Points 2-day In-person Seminar on Good Laboratory Practice Regulations - Introduction and Strategies for Implementation By - Dr. Steven S Duration: 2 Days Kuwahara Price: INR 18,000.00 (for 1 attendee) ***We do Provide In-House Training for the Same Subject (Minimum 25 Participants) Register Now Past Seminars Course Outline: Day 1 Course Outline: Day 2 Lecture 1: Introduction Lecture 5: Modifications of the GLP for Non-animal Testing Laboratories l Introduction and History of the GLP Regulations l The EPA GLP for chemical and physical testing l Definitions and General Application of the laboratories Regulations ¡ Modifications to the primary GLP l FDA and International GLP regulations: 21 CFR regulations Part 58, OECD Lecture 2: Part I of the US GLP Regulations Lecture 6: The Animal Welfare Act l Objectives and concepts of GLP's l The main provisions of the Act. l Organization and Personnel Requirements ¡ Need for a Care and Use Committee l Special organizational requirements ¡ Composition and function of the ¡ Management responsibilities committee ¡ The Study Director l The National Science Foundation and their ¡ The Quality Assurance Unit guidelines l Facility Requirements ¡ The three R's. ¡ Animal care facilities l Certification and Training Groups ¡ Operational areas and storage l Equipment Requirements ¡ Design ¡ Maintenance and calibration Lecture 3: Part 2 of the Regulations Lecture 7: European and other GLP Regulations l Operation of the Testing Facility l The European GLP ¡ Standard Operating Procedures ¡ How different are they? ¡ Animal Care Requirements l Other GLP and their key provisions. l Test and Control Articles ¡ Handling and Characterization ¡ Mixtures and Stability Studies Lecture 4: Part 3 of the Regulations Lecture 8: Types of Non-clinical Studies Subject to the GLP l Protocols for the Conduct of a Non-clinical GLP studies: preparation, conduct, documentation Study l SOP requirements: type, formats and l Safety Studies (Toxicology) enforcement Contents l Studies under the animal rule l Records and Reports l Determination of the dose for the "first use in ¡ Records keeping: format, length of time, man" study. archiving and reprocessing ¡ Study result presentation ¡ Storage and retention of records l Disqualification of Test Facilities ¡ Grounds for disqualification ¡ Reinstatement of a disqualified facility Overview: This course will present the regulations and guidelines that apply to the safety testing of medical products and also discuss the rules as they apply to testing laboratories that study samples derived from test animals or test subjects in clinical studies. The purpose of the course will be to instruct laboratory personnel in the material that they must know or prepare to pass an FDA inspection. The course will also discuss the types of studies that come under the GLP regulations. Who Will Benefit: Instructor Profile: Dr. Steven S Kuwahara l Directors Founder & Principal, GXP l Managers Biotechnology, LLC l Supervisors Steven S. Kuwahara, Ph.D. is l Lead workers in Product Development the founder and Principal of GXP l Regulatory Affairs BioTechnology LLC, a consulting l Quality Assurance and Quality Control firm that works in the areas covered by the GLP and GMP of Download Registration Form drugs, biologics, and nutraceuticals. ...more GlobalCompliancePanel GlobalCompliancePanel www.globalcompliancepanel.in www.globalcompliancepanel.com NetZealous Services India Pvt. Ltd. NetZealous LLC, 4th Floor, A, Block,Brigade Software Park, 43337 Livermore Common, Fremont Banashankari 2nd stage, CA 94539, USA. Bangalore-560070. INDIA. Phone: 800-447-9407 or Phone: 080 32473691 or Fax your PO to: 302-288-6884 Fax your PO to: 080 2642 1483 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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