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

Speaker

Instructor: Jerry Dalfors
Product ID: 703560
Training Level: Intermediate to Advanced

Location
  • Duration: 90 Min
This webinar will provide the 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.
RECORDED TRAINING
Last Recorded Date: Aug-2014

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$399.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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