WORKSHOP ON DATA INTEGRITY AND FDA INSPECTIONS 2017 - Seminar on GxP (GMP, GLP, GDP) Data Integrity, Quality Metrics and FDA Inspections
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Website http://compliancetrainings.in/product/gxp-gmp-gdp-glp-data-integrity-quality-metrics-fda-inspections |
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Category pharmaceutical; data integrity; quality metrics; FDA; inspections; gmp; glp; gdp
Deadline: April 17, 2017 | Date: April 18, 2017-April 19, 2017
Venue/Country: Hyderabad, India
Updated: 2017-02-14 00:12:40 (GMT+9)
Call For Papers - CFP
This seminar will give all attendees a complete insight with regard to quality and data integrity as well as prepare them for FDA inspections. This important seminar will cover an overview, as well as practical case studies with examples faced by Pharma industry today, while facing highest regulatory requirements and expectations from US, Europe, and other regulatory authorities.The speakers have between them 65 years of total experience between them and exposure to all above investigators and audits. This seminar is especially valuable to not only those within the Quality area of your Company, but also within other Departments to include Incoming Raw Materials, Manufacturing and Facilities.Interactive or question and answer sessions at the end of each session will add great practical value to your experience.Areas covered:Data integrity issues, reasons and compliance in QC laboratoryData integrity issues and compliance in Non-QC laboratorycGMP Regulations and Guidance21 CFR Part 11 and EU annex 11 requirements and examplesWarning letters, 483s on data integrity and how to resolve thoseQuality metrics and FDA expectationsGood documentation PracticesLaboratory OOS and incidencesQMS and Incident Management in cGLP environmentHow to prepare for and face Regulatory (FDA,EU, etc..) InspectionsSINGLE DELEGATE INR. 14,000 (early bird) Register before March 9, 2017 after which INR. 16,000GROUP REGISTRATION (4 attendees)INR. 42,000 (early bird) Register before March 9, 2017 after which INR. 64,000A must attend seminar for professionals in:Pharmaceutical Development CompaniesQuality Control Laboratories CompaniesQuality Departments of API ManufacturersQuality Departments of Finished Product ManufacturersContract LaboratoriesClinical Research Organisations
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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