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. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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 lifecycle process by providing you an example of actual activities during this cycle.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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)
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com