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.
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.
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
Course Provider
Jerry Dalfors,
