KK PD Partners in Diagnostics

- Training Workshops -

Taking You Beyond The

Standards.

Our Training Approach:

We believe that even the most challenging subjects can be interesting, if they are approached in the right way. In our workshops we use real, practical examples, interactive sessions and other techniques to bring the subjects to life. The goal of our training workshops are to give the participants not only knowledge, but also tools that they can use to improve their day to day work. These workshops have been developed for a broad range of disciplines throughout the organization, these include R&D scientists, manufacturing teams, quality assurance and product support professionals.

Risk Management (ISO14971):

Risk management is an integral part of the design and life cycle management

of your products and is required by various regulatory bodies. In most

organizations, the process of risk management is simply a checklist that is

completed as part of the development project. We will demonstrate in this

training that the application of effective risk management can serve the

company and its customers in many unforeseen ways. We will explore risk

analysis and apply it as a tool that can shorten and improve the development

process, drive up customer satisfaction and reduce costs as well as regulatory

exposure through the development of safe and effective products. This one

day workshop is aimed at individuals involved in the design, development,

manufacturing and quality assurance of your products.

Performance Evaluation (BS EN13612):

Performance evaluation is often the final part of the development process and

a great opportunity to gain experience and knowledge of your products

performance. Poor execution of performance evaluations can lead to delays in

the launch of products, frustration amongst the evaluation team and often

leads to additional work needed to complete regulatory submissions,

publications and other promotional activities. In this one-day workshop, we

will break down and review the entire process of a performance evaluation.

This will help you and your organization to plan and execute successful

evaluations in the future.

Customer Complaint Handling (ISO13485/ISO9000):

Customer complaints represent one of the single biggest risks to a company

from both a customer satisfaction and a regulatory standpoint. Complaint

handling is a highly complex process that involves many departments

throughout the company and the complaint files themselves are always subject

to intense regulatory scrutiny. In this two day workshop we will guide you

through the classification, management and documentation of complaints and

will explore some simple tools that are effective in both investigating

complaints and identifying their root cause. We will also provide simple and

practical advice on classifying and communicating incident reports, product

recalls and corrections.

Contact Us:

For further information on our training workshop and our prices, please

contact us at info@kkpd.net or call us at +49 171 446 1594.

KKPD GbR Janine Kukula & Paul Kenny

Steinerweg 1a

81241 Munich

www.kkpd.net