Thorough and Complete Investigations and Follow-Up - A Current Regulatory Expectation

Why Should You Attend :

Inadequate investigation of deviations or discrepancies is one of the most cited FDA observations in recent years. Anyone involved in the production of a pharmaceutical or medical device product should be aware of the deviation investigation and correction process. The webinar will include a discussion on recent FDA warning letter and 483 observations, analysis of the system deficiencies or nonconformance that caused each observation and the firm's corrective action and follow-up.

Attendees will learn more about the system for identifying, investigating and correcting the deviation or eliminating future similar deviations, which is often referred to as the CAPA system. This webinar will also include a discussion on the CAPA system.

Areas Covered in the Webinar:

• What should be investigated - complaints, audit observations, deviations, discrepancies, calibration out-of-tolerances
• FDA expectations for investigations and observations
• The investigation/problem resolution process - understand the problem, identify possible causes, data collection, data analysis, root cause identification, root cause elimination, solution implementation, verify success
• Tools for understanding the process - mapping, critical incident, performance matrix
• Tools for understanding the possible causes - brainstorming, is/is not, nominal group
• Tools for narrowing the investigation to the cause - data collection, data analysis
• Tools for determining the root cause - cause and effect, fault tree, 5 whys
• Corrective action
• Preventive action
• Verification

Who Will Benefit:

• QA managers and personnel
• Quality control
• Method development
• Analytical chemists
• Validation specialists
• Laboratory managers and supervisors
• Regulatory affairs
• Training departments
• Documentation departments
• Consultants

Instructor Profile:

Dr. John G. (Jerry) Lanese, PH.D. is the President of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small device component manufacturer. He has lectured throughout the world to clients and for major seminar providers. He was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.

Topic Background:

One of the observations made recently in FDA inspections is inadequate investigation or follow-up. During site inspections, FDA investigators focus on how the firm identifies, investigates and corrects or prevents deviations. Every firm should have an effective program for deviation identification and investigation. All personnel involved in the production and control of a pharmaceutical product should understand the need to identify deviations, identify the cause and take actions to correct the deviation, and/or prevent future occurrences of the deviation.

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