Customer Complaint Handling - Meeting the Customer and Agency Needs

Instructor: Peter Calcott
Product ID: 702024
  • Duration: 54 Min

recorded version

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Training CD

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Read Frequently Asked Questions

This webinar will provide valuable information on how to manage customer complaints, meeting their expectations and requirements and yet be compliant with the regulations of agencies in the USA, Canada and the EU.

Why Should You Attend:

This webinar will provide valuable information on the requirements for customer complaint handling as defined by the regulations in USA, Canada and the EU as the agencies reinterpret them and begin to more strongly enforce them. It will enable you to see how successful companies can translate these requirements and changing agency stance into workable processes that are compliant with the regulations and yet efficient from a business perspective, meeting their customer needs.

We will show you simple ways to make your complaint handling processes work for you and serve you rather than becoming a business burden or worse a compliance liability. Learn to benchmark your processes against those of successful companies We will also discuss examples of companies that run afoul of the agencies new interpretations resulting in warning letters and how from this information you will be able to assure that you do not suffer the same fate.

Areas Covered in the Webinar:

  • Elements of an effective customer complaint handling program.
  • What regulations govern these complaint handling programs in the light of increased enforcement?
  • How to develop and implement a program that is both compliant and efficient?
  • What a compliant program looks like?
  • How to streamline and benchmark your current system using risk based approaches?
  • Good and bad complaint handling process practices.
  • What the agencies expect from you to convince them you are in compliance and in control?
  • Where companies go wrong and get into regulatory hot water and how to avoid it yourself?

Who Will Benefit:

This Webinar is useful for all companies in pharmaceutical and biotech industries. All staff from following department must attend this course.

  • Quality and Compliance staff
  • Regulatory Affairs professionals
  • Manufacturing management
  • Validation staff
  • Quality Control staff
  • Senior Management and executives

Instructor Profile:

Peter Calcott , Ph.D. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.

He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he is chairman of the BIO RAC committee and a Board member of BayBio.

Topic Background:

Customer complaint handling is an area that is beginning to surface as a major compliance problem based on 2009 and 2010 Warning Letters issued by the FDA. The agencies are taking their regulations and reinterpreting and stepping up their enforcement. As new products are introduced with more complex requirements and the opportunity for home administration, complaints are increasing. This has overburdened the Quality function that must evaluate, investigate and correct them and respond to the customer.

Many companies respond by decreasing the level of investigation and documentation in response to this increase in workload, but it leaves them in a vulnerable position with the agencies. But it need not be like this. With Risk based approaches, it is possible to streamline processes and adequately address each complaint satisfying the customer and the agency.

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