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.
Back ground of the topic:
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.
Areas Covered:
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
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.
Instructor Profile
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. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
Live Session for one participant
Price: $225.00
Corporate Live Session 4 to 10 participants in single location.
Price:$885.00
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $275.00