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


Instructor: John G Lanese
Product ID: 701410
Training Level: Intermediate

  • Duration: 90 Min
This webinar will discuss the current regulatory expectations on how a firm identifies deviations, problems and trends, investigates these to determine the cause, and recommends corrective and preventive actions. It will also explain how to complete these actions and demonstrate how the actions accomplishes the intended correction or prevented the repeated occurrence of the problem.
Last Recorded Date: Jun-2013


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)



Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions


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.

Follow us :



Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2023 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method