Documentation is the backbone to compliance in an FDA regulated organization. We have all heard “if it isn’t documented, it didn’t happen.” Every action taken in producing pharmaceutical products must be detailed in a procedure. The deviation from these procedures can result in delays in product shipment, investigations, potential rejection of product and FDA findings of inspection.
Why Should You Attend:
Right First Time Documentation specifically addresses both compliance and nonvalue added actions/cycle time reduction. Implementing this program, though not easy or quick, will begin to pay dividends from the beginning.
Areas Covered in this Webinar:
This webinar will give you a process to implement RFT for FDA compliance in your organization. This will move the focus from reviewing and correcting documentation errors to having each individual who performs documentation taking responsibility for not making errors.
The benchmarks and best practices for implementing RFT in an organization
How to determine your organizations initial documentation accuracy and the metrics to set goals and track progress
Utilizing a cross sectional team to implement RFT
Learn how to Manage the change to RFT in your organization
Determining the costs versus benefits of RFT
Why accountability is the key to RFT implementation
Who Will Benefit:
Site Leaders/Plant Managers
Directors of Quality and Manufacturing
Manufacturing Supervisors and Managers
QA, QC Supervisors and Managers
Maintenance Supervisors and Managers
Laboratory Managers and Supervisors
William (Bill) Miller a Principal at Black Gold Gray Consulting. With more than 35 years of GMP Manufacturing, Bill has held manager/director positions in Quality Assurance, Manufacturing, Packaging, Purchasing, Distribution and Plant Management.His focus has been turning around organizations
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