Complaint Files, Procedures and Interrelationship with Complaint Handling, CAPA, Change Control, Adverse Event Reporting and Recalls

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• Complaint Files, Procedures and Interrelationship
  with Complaint Handling, CAPA, Change Control,
  Adverse Event Reporting and Recalls

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• 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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• 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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• 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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• 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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• 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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• 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
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• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com