Title: Complaint Files, Procedures and Interrelationship with Complaint Handling, CAPA, Change Control, Adverse Event Reporting and Recalls
1- Complaint Files, Procedures and Interrelationship
with Complaint Handling, CAPA, Change Control,
Adverse Event Reporting and Recalls
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2- 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.
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3- 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.
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4- 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.
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5- 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)
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6- 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.
www.onlinecompliancepanel.com 510-857-5896
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7- 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
QA 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.
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
8www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com