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    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 | Want to Edit it Edit Freely

    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 laboratory

    Data integrity issues and compliance in Non-QC laboratory

    cGMP Regulations and Guidance

    21 CFR Part 11 and EU annex 11 requirements and examples

    Warning letters, 483s on data integrity and how to resolve those

    Quality metrics and FDA expectations

    Good documentation Practices

    Laboratory OOS and incidences

    QMS and Incident Management in cGLP environment

    How to prepare for and face Regulatory (FDA,EU, etc..) Inspections

    SINGLE DELEGATE

    INR. 14,000 (early bird)

    Register before March 9, 2017 after which INR. 16,000

    GROUP REGISTRATION (4 attendees)

    INR. 42,000 (early bird)

    Register before March 9, 2017 after which INR. 64,000

    A must attend seminar for professionals in:

    Pharmaceutical Development Companies

    Quality Control Laboratories Companies

    Quality Departments of API Manufacturers

    Quality Departments of Finished Product Manufacturers

    Contract Laboratories

    Clinical Research Organisations


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.