Application retirement is a major paradigm shift toward holistically managing the enterprise application portfolio which allow companies to retire seldom-used applications to significantly cut hardware, storage and software maintenance costs in addition to indirect expenditures such as power, space, etc. Enterprises across a variety of industries are looking for ways to reduce IT expenditures

In this seminar we will talk about new innovations that will simplify and streamline the application retirement process, allowing for measurable ROI and reduced TCO. This seminar will also show you how to compute the ROI by adopting a process-oriented approach to retire legacy applications.

One of the most common reasons noted by the FDA for recalls of medical device is improper validation.

It is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your organization How do we get there? After we have a clear understanding of the regulatory intent of validation, the key for a robust process validation is the use of six sigma techniques and risk management. The rigor of a validation should be tied to the individual risk assessments of your products Critical Quality Attributes laid out in your design controls. Using the GHTF Process Validation Guidance document as a backdrop, this seminar will provide a review of the fundamentals of validation, provide guidance on using a risk classification scheme to define the rigor of testing and provide a guidance on the use of Six Sigma tools to create and sustain a state of validated control.

Why you should attend:

* Did you know that poor or ineffective Process Validation was one of the top citations noted in recent FDA warning letters and 483s?
* Do you know that poor or ineffective Process Validation also creates lower process yields and negatively impacts company profitability?
* Do you know how to create robust and complaint processes?

Areas Covered in the Session:

* Review the regulatory basis for process validation.
* Understand the difference between Validation and Verification.
* Review IQ, OQ, PQ
* Create a robust validation plan using six sigma techniques while maintaining compliance with QSR 820, ISO 13485, and GHTF.
* Creating risk classification scheme to help define the rigor of your validation.
* Using risk management at the Qualification stage to assist in revalidation and change control activities while in production.
* Using Risk Management to Maintain a state of control after initial validation is complete.

In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements.

One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory requirements. The changes reinforce the need for control over outsourced processes and recommend using the methods found in the ISO 9001 Purchasing clause. These changes also include suppliers who are part of the same parent organization, such as a separate department or division. To help clarify the requirements, ISO issued a guidance document on Outsourced Processes. The presentation explains the changes to ISO 9001, and recommendations in the guidance document. We take a practical implementation approach, showing how to evaluate and select outsource suppliers, especially service suppliers. We develop methods for written supplier agreements, which define controls and expectations. A critical element for success is monitoring and measuring of the delivered service. This presentation incorporates supplier scorecards as the most effective tools for this purpose. This webinar explains the changes in ISO 9001:2008 related to outsourced processes. While the literature says this new version only contains clarifications, this clarification can have a big impact on a Quality Management System. We look to ISO’s guidance document on outsourced process to ensure we understand the intent.

Why you should attend: ISO 9001:2008 clarifies the concept of an outsourced process and expects that you will manage any outsourced process using the purchasing methods in Clause 7.4. The new definition of an outsourced process includes the cases where you obtain a service from your parent company or from a sister division. This broadens the definition to bring in “suppliers” that are not traditional external companies.

Moving the management of outsourced processes to purchasing brings in the concepts of supplier evaluation, selection, and monitoring/measuring. This broader definition includes cases without monetary transactions! You will also learn about the ISO guidance document that explains the change in the standard. In addition, the new concepts mean that you may have a new set of questions (and requests for records) from your ISO 9001 registrar. If your Quality Management System (QMS), through its documented procedures, cannot answer these question quickly, and without hesitation, then you, and your team need to attend this webinar!

* Do you know all the processes required for your quality management system?
* Do you know who performs each process, i.e., can you identify the process owner by job title and name?
* Can you list the QMS processes that you have outsourced?
* Do you have records of the requirements for this supplier, potential supplier evaluation, and your selection criteria?
* Can you show how you monitor and measure the QMS process the supplier provides?
* Do you have records monitoring, measuring, and feedback for the supplier performing the outsourced process?

Historically, companies have viewed billing strictly from an operations perspective -- get invoices and statements out the door as efficiently and cost-effectively as possible. But did you realize there are strategic considerations to the billing function as well - ranging from enhanced customer retention, brand loyalty and cross-selling opportunities along with improved cash flow, dispute management and customer service? From this perspective, it's not just about bills going out; it's also about cash coming in.

Here’s your FREE pass to join an expert panel for an interactive discussion on the operational and strategic benefits of billing. Hear from a panel of experts on how companies are leveraging new billing processes not only to improve their operations but also to support their strategic objectives.

Panel includes: Tracy Garrett, Shared Services A/R Manager, Oldcastle APG
- Rob Hollenbach, Director Shared Services, IDEXX Laborato
- Megan Locke, Credit Supervisor, Chiquita Brands Int'l
- Mitch Rose, VP Marketing, Billtrust

Key topics will include:

- Paper and electronic bill delivery channels
- Advanced electronic bill delivery channels
- Key factors to consider when outsourcing invoice and statement delivery
- Advanced technology for online invoice presentment and payment
- Operational and strategic benefits of outsourced billing

Legal professionals have to balance the desire for an effective presentation with the need to be more conscious about costs related to the litigation. There is also pressure to be on the cutting edge of courtroom presentation technology. Time and cost constraints also affect the selection and development of demonstrative evidence. The economics of preparing for and trying cases is changing. Our methodology will help in better organizing the visual support of a case by managing expenses at every step of the discovery and trial preparation stage. Participants will learn about the range of methods that are available for presenting the exhibits and supporting visuals that will effectively convey the intended message, help carry the theme of the case, and impact the jury so that the intended message will be carried into the jury room.

In this one hour webinar, you will learn how to:
1. Look at the case from a visual perspective
2. Better understand how to develop a theme and convert it to an effective message
3. Use a “reverse engineering” approach to developing visual support
4. Find the right balance of media mix and budget

As a bonus, you will receive:
Stephen is off ering participants a full case triage review at no charge. This is a $275.00 value. This includes a review of all liability and damages material, photographs, radiology, expert reports, etc. The participant will receive a written report analyzing the case from a demonstrative perspective, including suggestions for visual support, noting any missing material, and a proposal for the most effective way of presenting the case at mediation, settlement conference or trial.