Deviation Management - Workshop - Training for the Principal Investigator

Why Should You Attend:

Deviations have been in the top five of all FDA (and other regulators) citations for more than twenty-five years. Regulators consistently cite firms for poor investigations and failure to identify and eliminate root causes. Additionally, it is estimated that each deviation currently costs more than 10,000 USD to investigate and manage without a noticeable return on investment for this expenditure as the deviations routinely recur. This webinar will:

• Provide Basic Understanding for why we do investigations
• Learn how and when to start an investigation
• Become familiar with the tools for proficient data gathering
• Be able to determine the right type of root causes
• Describe Corrective Actions and Preventive Actions process
• Describe the primary goals for a good system

For nearly 25 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 detailed training for principal investigators to learn techniques and tools that allow you to perform much better investigations. The discussions will ensure the documentation you generate reflects the work that was accomplished in a manner that clearly demonstrates a thorough investigation, the scope was sufficiently broad and ultimately that problems are eliminated such that they do not recur.

Areas Covered in the Webinar:

• Requirements for deviations
• US Regulations
• EU Regulations
• ICH Guidelines
• Management
• Customer
• Purpose of Investigation
• How to tell a good story
• Characteristics of a good investigation
• Characteristics of a good investigator
• Good and Bad Stories
• Good Investigation Techniques
• Interviewing Techniques
• Record Review
• others
• Getting to Root Cause
• 5 Whys
• Fishbone Diagram
• Others
• Putting In Actions To Make The Problems Go Away
• Code the problem so you are sure you can find it
• Effectiveness Verification
• Preventive Action – where we really should be spending our resources

Who Will Benefit:

• Drug and Medical Device personnel involved in executing and managing deviation investigations, Quality Assurance
• From Regulated industries – Pharma, Bio-pharma, Medical Device – all aspects from clinical to commercial.

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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