Guest Speaker: Michele Donatich, Director of Quality Systems, Cardinal Health

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Complaint Handling affects directly 2 of the most important stakeholders of a life science company:  your customer and the FDA. So it’s no surprise that the consequences of complaint handling non-compliance for today’s Life Sciences manufacturers are costly and significant:

• Complaint handling processes that do not meet FDA regulations can result in warning letters, restrictions, fines, recalls, litigation, and potential shutdown. Complaint handling systems have come under intense scrutiny by the FDA in recent years and in 2005, the FDA cited medical device firms for deficiencies in their complaint handling procedures more frequently than in any other area
  
• Complaint handling is a critical aspect of customer service and failure to respond to a complaint will decrease customer satisfaction and therefore customer retention

Ineffective complaint handling can lead to damaging a company’s brand reputation, its products' position in the market, as well as its ability to market and profitably sell those products.

To overcome those challenges, companies need to implement a corporate-wide complaint handling system, engaging all parts of the organization, to improve complaint information capture and on-time regulatory submissions. Streamlined investigations, CAPA implementation effectiveness, and increased visibility of complaints across the enterprise are crucial success factors.

Join Pilgrim Software and Michele Donatich, Director of Quality Assurance, Cardinal Health to learn:

• What are the essential elements for an automated complaint handling system
• How to engage the entire organization, from field reporters to plant engineers, in an effective complaint handling program
• How to set up a closed-loop process for complaint investigations and FDA reporting
• How Cardinal Health is addressing these challenges by implementing Pilgrim’s solutions

Discover how an effective complaint handling solution can keep you in compliance, lead to improved product quality and higher customer satisfaction while reducing costs.

Who should attend this Webinar?
RA/QA, IT, Operations

About Cardinal Health

Cardinal Health, Inc., a company with its roots in drug distribution, has transformed itself into the undisputed leader of products and services that improve the quality and efficiency for the entire health care spectrum – including drug researchers and developers, health care administrators, pharmacists, nurses, physicians, and surgeons. Cardinal Health products
and services focus on improving people’s lives.

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