Batch Production Record and Device History Record Review and Quality Assessment to ensure compliance with DMF and DMR specifications
Compliance Key INC - Medical Device Training
Jerry Dalfors is Keynote Speaker at Compliance key Inc.He 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.
Webinar Id: LSHCJB002
12:30pm PT | 03:30pm ET
01/23/2018
Duration: 60 mins
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.
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 this webinar?
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.
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 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 can Benefit:
Quality and Documentation Personnel within the industry
Pharmaceutical, Medical Device and Solid Dosage as well as FDA, ISO, PDA, ISPE
Quality, Operations , Development Quality and Documentation Personnel within the industry. Pharmaceutical, Medical Device and Solid Dosage as well as FDA, ISO, PDA, ISPE
Visit:https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=972&speakerid=35
Compliance Key INC
717-208-8666
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