VALIDATION UNIVERSITY

March 28 – 30, 2023

Join KENX for hands-on training for engineering, quality, C&Q and validation professionals within the pharmaceutical, biotech, medical device and related industries. Participants can create-their-own-experience by choosing from over 55 tutorials and benefit from the wealth of knowledge and useful material our faculty exchanges. Val-U offers a hands-on experience in which lessons learned turn into immediate, actionable results.

Join KENX at industry’s validation event of the year! Whether you’re in QA, validation, or engineering; a novice or advanced professional; or, attending in-person or online, this is your chance to network with over 200 of like-minded colleagues in the FDA-regulated environment.

SPECIAL PRICING FOR CAI: $1,295 IN-PERSON, $995 VIRTUAL

AGENDA

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CAI

December 7, 2022

Sparta Systems, a Honeywell Company

July 23, 2020

VTI Life Sciences

Product Complaints

Handling product complaints and recalls are (and have always been) a regulatory hot issue for both the FDA and other global regulators. In fact, there have been a flurry of Warning Letters on handling complaints in the last few years and the FDA has recently issued two guidance documents on product recalls. The time has never been greater to ensure you have established best in class procedures for receiving, reviewing, and evaluating complaints. Moreover, from Covid and beyond it is essential you have a risk mitigation plan for product recalls to ensure you can handle today’s supply chain challenges in an instant. Come and attend KENX’s Handling Product Complaints and Product Recalls forum, network with your peers and ensure you have up-to-the-minute modern processes in place to master these critical areas.

PRODUCT COMPLAINTS HIGHLIGHTS:

Initiating, Performing and Documenting a Complaint Investigation

How to Use Risk-based Decision Making in Handling Complaints

Automate Field Alerts and Actions Processes to Streamline Identification, Reporting, and Analysis

End-to-End Methods to De-Escalate Product Complaints

Utilize Data Analytics / AI to Obtain Actionable Insights and Streamline Processes

Building an Effective and Customer-Centric Complaints Team

Learn How to Effectively Utilize CAPA in the Complaint Handling Process

Critical Steps to Successfully Adhere to the FDA Incident Timeline Requirements

Using Social Media as a Tool to Gather Information about Produce Complaints and Adverse Events

Developing Robust Adverse Events Risk Management Processes and Execution Strategies

Manage Adverse Events Incidents by Reducing Risks and Optimizing Reporting Processes

PRODUCT RECALLS HIGHLIGHTS:

Review FDA’s Recent Voluntary Recalls (March ’22) and Recalls (March ’20) Final Guidance

Understand the Critical Steps to Initiate a Recall and Design an Effective Withdrawal Strategy

Learn the Key Factors to Determine Product Recall or Removal Justification

Prepare Impactful Product Recall and Removals Communication Strategies

Effective Strategies to Ensure Product Recall Tracking and Reporting Accuracy

Implement an Effective CAPA Management System

Use Risk Assessment and Mitigation for Recall Decision Making

Global Recalls – Prepare a Contingency Plan for a Large-Scale Event

Write Regulatory Compliant and Effective Public Notices and Cross-Functional Internal Communications

Strategies for Product Disposal, Effectiveness Checks and Concluding a Product Recall

Identify, Report, and Risk Assessment of Invisible Defects

Venue

The Cambria Hotel, Center City Philadelphia

219 s Broad St, Philadelphia PA, 19107

Register Here

Who Should Attend

Quality Assurance/Quality Control
Regulatory Affairs
Quality Risk Management
Corporate Risk Management
Legal and Compliance Officers
Operations, Production, and Manufacturing Directors and Managers
General/Corporate Counsel

Medical Affairs
Medical Communications
Media and Public Relations
Complaint Handling Management
Recall Management
Quality Engineers
Process Engineers
Supply Chain

SPECIAL PRICING: $1,295 IN-PERSON, $995 VIRTUAL

VALIDATION UNIVERSITY

March 28 – 30, 2023

55 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe

Facility Commissioning & Equipment Qualification

Process Validation

Cleaning Validation

Computer System Validation

Personnel In The Following Environments Should Attend:

Venue

Register Here

SPECIAL PRICING (1)

FACULTY

SPECIAL PRICING FOR CAI: $1,295 IN-PERSON, $995 VIRTUAL

Product Complaints

Venue

Register Here

SPECIAL PRICING (1)

Who Should Attend

Faculty