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    Batch Production Record and Device History Record Review and Quality Assessment

    View: 108

    Website https://compliance2go.com/product/?pid=CP2014-342Biotechnology,MedicalDevice,Pharmaceutical | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: August 13, 2014 | Date: August 13, 2014

    Venue/Country: online, U.S.A

    Updated: 2014-08-01 19:18:44 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    Typical Elements Required to be Included in the Batch Production Record and the Device History Record in order to Accomplish a Quality and Cost Effective Review and Quality Assessment based on current Regulatory Expectations.

    Why should you attend

    A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation of the production processes for both injectables, devices and solid dosages.

    Quality Systems require both Operations and Quality Departments to be unified with the overall intent of minimizing patient risk by documenting the process in a fashion that is technically accurate and easy to demonstrate that we are thinking and operating with the same objectives as the regulatory agencies are required to enforce

    Description of the topic

    Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product with established specifications before a batch can be released for distribution

    BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch is released for distribution. Production and laboratory control records for earlier, non-critical process steps may be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s).

    All incidents or deviations, investigation, and OOS, OOT, OOL reports should be reviewed to ensure there is no product quality impact by providing technically written sound scientific rationale for the assessment and conclusion as part of the batch record review before the batch is released.

    Areas Covered in the Session

    Generation of BPRs, DHRs and SOPs to provide technically written instruction sets to eliminate operator errors. Training is NOT the primary means of generating and error free operation

    Production and In-Process Controls

    Inspection, Packaging and Identification Labeling of Finished Products and Intermediates

    Responsibilities for Production Activities

    Data selection and entry into the statistical tracking from the BPR and DHR

    Incident / Deviation Tracking along with Customer Complaints and CAPA changes

    Annual Reports

    Who will benefit:

    Quality and Documentation Personnel within the industry


    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.