Deviation Management - Why Have We Not Solved the Problem?

Why Should You Attend:

For nearly 20 years, FDA and other regulators have cited failure in problem investigation systems as amongst the top 5 of all observations issued.

Instead of continuing to pour time and money into failed approaches, attend this training to understand why our approaches are not working and discover approaches that are successful in finally solving our problems and meeting our business needs.

Deviations occur across the pharmaceutical and device industries nearly every day. Companies have spent hundreds of hours and thousands of dollars to investigate deviations, identify their causes and implement corrective actions to prevent their recurrence. Yet with all of the investment we continue to frustrate both our personnel and our management as the same problems continue to recur.

This presentation discusses the possible causes and potential solutions to taking a different approach to looking at deviation investigations.

Areas Covered in the Webinar:

• Standardizing definitions
• Five actions we currently are taking that are not producing positive results.
• Wrong thinking leading to wrong actions
• Wrong speaking/writing leading to confusion
• Wrong organization, roles and responsibilities
• Wrong design and metrics
• Wrong tools or using tools in wrong ways
• Five Things we can do differently.
• Changing thinking leading to new actions
• Speaking/Writing that provides clarity
• Appropriately defined roles and responsibilities
• Design that leads to solutions
• Using right tools in right ways

Who Will Benefit:

• Quality Assurance Personnel and Management
• Operations personnel and Management
• Investigators

From Regulated industries – Pharma, Bio-pharma, Medical Device – all aspects from clinical to commercial.

Free Materials:

• Copy of article on topic

David Husman
President and Principal Consultant, David Husman Consulting LLC

Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 18 years as a consultant to biopharma, pharma and device industries.

Experience has spanned from R&D to Commercial Manufacture

Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.

Extensive experience in laboratory operations including but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations.

Experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control.

Expert level in Compliance and Quality System development.

Executed numerous Data Integrity assessments and remediation projects worldwide.

Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs.

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