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Complaint Files, Procedures and
Interrelationship with Complaint Handling,
CAPA, Change Control, Adverse Event
Reporting and Recalls
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

Instructor Profile:
Ms. Vanessa Lopez has held a wide variety of leadership roles in the
Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and
Environmental regulated industries as well as the Consulting Services industry. She
has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences,
among others. She possesses over 20 years of experience focused on
development, implementation, driving improvements and monitoring of Quality
Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality
Systems and Supplier Quality activities.
Ms. Lopez has in-depth knowledge, coaches on interpretation and application of
US regulations, EU directives, specific country regulations (Japan, Canada, and
others), national/international standards and guidance documents. She has also
held positions within the CAPA, Material, Safety and Management Review Boards
as well as others.

Description:
The course will touch on complaint sources, and details will be furnished
on the interrelationships regarding Complaint Handling/Change Control/Adverse
Event Reporting/and Recalls. The course will also include timeline requirements
associated with adverse event reporting, which reporting formats to use, when to
recall and types of recalls.
In addition, the webinar will incorporate the Complaint Handling Life-Cycle
Process and an example of activities involved in this life cycle. This webinar will
discuss complaint handling implementation challenges, in addition to pitfall
challenges.
At the end of this webinar, there will be a conclusion section, where points to take
into account with the integration of CAPA/Change Control/Adverse Event
Reporting/Recalls/Complaint Files in the Complaint Handling Life-cycle, will be
detailed.

Benefite of attending the webinar :
By attending this webinar you will be provided with detailed information
to help you gain a better understanding of the requirements of a complaint
handling system and the interrelationship other regulated activities have with the
referred system. In addition, it will walk you through the complaint handling life-
cycle process by providing you an example of actual activities during this cycle.

Objectives of the Presentation:
The following topics will be addressed during this webinar:
 Medical Device and Drug Complaint Handling Requirements (US)
 Complaint Sources
 Interrelationship of Complaint Handling, CAPA, Change Control, Adverse Event
Reporting and Recalls
 Reportable Events, Voluntary and Mandatory Reports, and Reporting timelines
 Complaint Handling Life-Cycle Process (including an example that embraces
activities related to bullet three, above)

Who Can Get Benefited:
People who are into Regulatory Compliance Professionals, Quality
Assurance Professionals, Quality Control Professionals, Regulatory Affairs
Professionals, Complaint Handling Professionals, Quality Engineers, Service
Technicians and Engineers, Manufacturing and Design Engineers, Process
Development Personnel, Customer Service Personnel, Sales Representatives will be
more benefited by attending this webinar.

How Live Session 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.
How Recorded Session 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.

Get Connected With Us:
www.onlinecompliancepanel.com

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Regulatory requirements (us) for complaint handling in the medical device and pharmaceutical industries

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