by complianzworld.com 2014 - Thorough and Complete Investigations and Follow-up A Current Regulatory Expectation

Description:
This training will address the adequate investigation of deviations, an area that is receiving FDA attention as evidenced by citations in Warning Letters and 483 observations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future.
Course Objective:
Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that include the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up.
Course Outline:
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
Target Audience:
QA document reviewers
QA personnel responsible for reviewing investigations reports
QA personnel responsible for the deviation and investigations systems
Quality and Operations personnel responsible for investigations
Personnel from all units responsible for initiating investigations.
Speaker:John G. Lanese
Dr. John G. (Jerry) Lanese, PH.D. CMC 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.
Price List:
Live : $2099.00
Group : $729.00
Recorded : $239.00
Training CD-DVD :$ 319.00
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