Thursday 4th April, 2013
10:00am to 11:30am
Overview: 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.
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.
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
Who Will Benefit:
Jerry Dalfors Mr. Jerry Dalfors has extensive (40 years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages.
Livermore Common, Fremont, CA, 94539
Event Link - http://bit.ly/144K5nz
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4th April 2013