This webinar focuses on current regulatory expectations regarding the identification, investigation, and correction of deviations within firms, emphasizing the importance of an effective corrective and preventive action (CAPA) system. Participants will learn about FDA inspection observations related to inadequate investigations and how to implement corrective actions to prevent future issues. The session is beneficial for personnel in various quality and production roles, and includes opportunities for interactive engagement and certification of attendance.

1. Thorough and
Complete
Investigations and
Follow-up :-
Current
Regulatory
Expectation
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

2. Instructor Profile:
John G. (Jerry) Lanese is an independent consultant with a focus on Quality
Systems and the components of an effective Quality System. He received a BA and
MS from Middlebury College and a Ph.D. in Analytical Chemistry from the
University of Michigan and began his career teaching Analytical Chemistry in a
small liberal arts college.
In 1994 Dr. Lanese formed his own company, The Lanese Group, since then he has
been a consultant in the area of quality system and cGMP compliance and has
been consulted by small and large medical device and pharmaceutical companies,
including companies under FDA Consent Decree, API and excipient manufacturers,
electronic firms and other manufacturing organizations.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

3. Description:
In this webinar we will discuss the current regulatory expectation on how a
firm identifies deviations, problems and trends, investigate these to determine the
cause, recommend corrective and preventive actions. It would also explain how to
complete these actions and demonstrate that the actions accomplished the
intended correction or prevented the repeated occurrence of the problem.
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

4. Why Should you Attend?
One of the observations made recently in FDA
inspections is inadequate investigation or follow-up.
During site inspections, the 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.
Who can Benefit?
Personnel in production, quality control, quality
assurance, materials, and functions that support these will
benefit from this webinar.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

5. Objectives of the Presentation:
The objectives of the presentation are to learn 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 discuss
further about the CAPA system.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

6. Live Session - How it works?
• Username and Password will be sent to you 24 hours prior to the webinar
• Presentation handouts in pdf format will be mailed to you
• Login to the session using the username and password provided to you
• Get answer to your queries through interactive Q&A sessions via chat
• Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

7. Recorded Session - How it works?
• A link will be provided to you upon purchase of the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf format will be mailed to you
• Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

8. Get Connected With Us:
www.onlinecompliancepanel.com
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com