Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment

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. The documentation should also serve to demonstrate that we are thinking and operating with the same objectives that the regulatory agencies are required to enforce.

This webinar will discuss how you can generate BPRs, DHRs and SOPs to provide technically written instruction sets that will eliminate operator errors, and are in compliance with regulatory requirements. You will have the opportunity to learn from an expert whose works and projects, during his 40-year tenure in the industry, have never received a 483.

Areas Covered in the Webinar:

• 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:

This webinar will provide valuable assistance to the following personnel from biotech, pharmaceuticals and medical device companies:

• Regulatory affairs
• QA managers and personnel
• Documentation and IT
• Operations
• R&D
• Scientists

Instructor Profile:

Mr. Jerry Dalfors, has extensive (40+ years) 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 an expert in almost 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.

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