Typical Elements Required to be Included in the Batch Production and the Device History Record in order to Accomplish a Quality and Cost Effective Review and Quality Management system based on current Regulatory Expectations in accordance with the submitted DMF and DMR (510K).

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 injectable, 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.

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 an error free operation.
•  Production and In-process control systems
•  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 service complaints and CAPA corrective action
•  Annual Reports

Learning Objectives

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 branding 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.

Who Will Benefit

•  Quality Professionals
•  Documentation Professionals
•  Operations Professionals
•  Product Development Professionals
•  Documentation and IT
•  Regulatory affairs
•  R&D Professionals
•  Scientists



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