November 9-10, 2020 | Virtual Platform
By having an effective complaint management system, life science organizations have a better
chance to ward off inspections by using the appropriate guidelines and regulations. Monitoring
complaint trends over time and having a complaint program improves the customer’s
experience with your products.
Part of the process is being ready for anything, while a recall is a scenario we want to avoid, we
need to be ready, we need to have a plan to go to, we need to learn how to mitigate and follow
regulations. Register today for the Product Complaints and Recalls Virtual Summit and gain the
critical knowledge needed to be prepared to excel when facing complaints and recalls, learn
how to be proactive and not reactive.
Speaker Highlights
Erik Mettler
Assistant Commissioner for Partnerships and Policy, ORA (Office of Regulatory Affairs) - Food and Drug Administration (FDA)
Weiping Zhang
Global Leader in QA/RA, Risk/Safety/Recall/Reliability and Clinical - GE HEALTHCARE
Jaylaxmi Nalawade
Associate Director, Pharmacovigilance and REMS - LUPIN PHARMACEUTICALS
Thomas Morrissey, MD
Vice President, Product Safety - EDWARDS LIFESCIENCES
Khaudeja Bano
Executive Medical Director, Combination Product Safety Head - AMGEN
Sharon Perez
Senior Director of Global Medical Safety - Novocure
Vaishali Shukla
Quality Site Head, Kite - a Gilead Company
Sameer Thapar
Adjunct Professor, Drug Safety & Pharmacovigilance - TEMPLE UNIVERSITY
Ana Marie Sacro
Engineering Manager - Fujifilm Irvine Scientific Inc.
Erik Mettler
Assistant Commissioner for Partnerships and Policy, ORA (Office of Regulatory Affairs) - Food and Drug Administration (FDA)
Willem van Alst
Complaint Handling & Vigilance Reporting Manager Post Market Surveillance - NOBEL BIOCARE SYSTEMS
Top Reasons to Attend:
- 1- Learn from our experts how to successfully thrive during the pandemic
- 2- Use the information from the Complaints and make it valuable feedback to enhance quality
- 3- Prepare and identify how to avoid inspection findings
- 4- Work effectively with the FDA during a Recall
- 5- Upgrade your Post Market Risk Assessment qualities from complaint investigation up to a potential recall
WHO SHOULD ATTEND
● Product Complaints
● Consumer Complaints
● Quality Assurance / Quality Control
● Product Safety/Recalls
● Due Diligence
● Product Recalls
● Pharmacovigilance
● Legal
● Consumer Complaints
● Quality Assurance / Quality Control
● Product Safety/Recalls
● Due Diligence
● Product Recalls
● Pharmacovigilance
● Legal
● Quality Systems and Engineering
● Patient Safety
● Drug Safety
● Risk Management
● Medical/Consumer/Regulatory/ Clinical Affairs
● Call Centers/Customer Service
● Compliance
● CMO Management
● Patient Safety
● Drug Safety
● Risk Management
● Medical/Consumer/Regulatory/ Clinical Affairs
● Call Centers/Customer Service
● Compliance
● CMO Management
● Business Support Coordination
● Product Surveillance
● Clinical Operations
● Quality Compliance and Audits
● Post marketing Surveillance
● Complaint Handling Quality Compliance
● QA and Supply Integration
● Global Device Coordination
● Product Surveillance
● Clinical Operations
● Quality Compliance and Audits
● Post marketing Surveillance
● Complaint Handling Quality Compliance
● QA and Supply Integration
● Global Device Coordination
NETWORKING CAPABILITIES
✔ Virtual Matchmaking: Visit our virtual lobby and connect with fellow attendees using our
platform’s matchmaking technology. You can chat, video, and even make a list of the people you want to meet and the knowledge you’re looking to gain through our bespoke 1:1 match-making services.
✔ Networking Breaks throughout the Summit will give you the chance to connect and meet in- depth your fellow attendees as well as our Sponsors and Speakers.
✔ The platform we use allows us to make polls, QA, and chat during the sessions.
✔ Virtual Happy Hour: Grab a drink and bring it to your screen to cheers from afar while continuing to chat with and get to know your fellow conference participants.
✔ Networking Breaks throughout the Summit will give you the chance to connect and meet in- depth your fellow attendees as well as our Sponsors and Speakers.
✔ The platform we use allows us to make polls, QA, and chat during the sessions.
✔ Virtual Happy Hour: Grab a drink and bring it to your screen to cheers from afar while continuing to chat with and get to know your fellow conference participants.
