Fremont, California (PressExposure) March 22, 2013 -- Description:
The fundamental reason for issuance of 483, Warning Letters and Consent Decrees from the FDA in the areas of injectables, devices and solid dosagesis faulty technical documentation of the production processes. Why this happens is that written procedures that need 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, are not followed.
This webinar will give participants a clear understanding of the procedures needed for technical documentation for these products. It will offer participants learning of the ways in which documentation has to be done, which should ideally be in this route:
BPRs, DHRs and laboratory control records for critical process steps have to be reviewed and approved by the quality unit(s) before a finished product batch is released for distribution. Following this, 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.
This webinar will help participants gain a proper understanding of these procedures.
When:April 4, 10:00 AM PDT | 01:00 PM EDT
Jerry Dalfors has over four decades 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 worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents and project management of several multimillion dollar projects.His work has included 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.
He has written numerous submission documents for product, process and facility approval/licensing. These 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 has been received and accepted by the FDA and other regulatory agencies.
The webinar will benefit
o Documentation Personnel
Duration: 90 minutes
To enroll for this webinar, contact