Time:14:00 GMT

Global food and beverage manufacturers are on high alert. Business challenges facing companies today include increased regulatory reporting requirements, concerns over food safety and accurate nutritional label content, as well as poor raw material data traceability, and cumbersome collaboration across the global supply chain.

Many leading food and beverage manufacturers successfully implement Product Lifecycle Management (PLM) for Process integrated product development tools and automated supplier collaboration capabilities. The case study by Tyson Foods demonstrates the advantages of these solutions.

Rapid growth presented the company with a maze of challenges to overcome. Discover firsthand how Tyson Foods leveraged PLM to achieve the following benefits:

•Accelerated time to market

•Improved collaboration and reduced cycle times

•Empowered decision-making by improving visibility

•Shortened time needed to complete audits

•Minimised risk by bolstering supply chain contingency planning

•Decreased ingredient and packaging costs

The webinar will be followed with a live Q&A session, this is your chance to get your questions answered. Make the most of it, register today!

The Speakers:
Kimberly Glenn, Director of Research and Development, Tyson Foods. Kim started her career at Hudson Foods developing products for national account customers and wholesale clubs. With the acquisition of Hudson in 1997, she came to Tyson Foods to develop items for the school foodservice and hospitality arenas. In 2004, she took on the challenge of serving as business lead for a product data management implementation program. Since early 2007, Kim has served as Director of R&D responsible for Regulatory Labelling and Specifications, Nutrition Services, Sensory Insights group, and the Product Data Management software suite.

Wes Frierson is the Director of Product Strategy for Oracle's PLM for Process solution. In the past, Wes worked in Product Development and Consulting roles helping to develop and deploy the product around the world. Wes has extensive experience in the Consumer Goods and Retail industries, having worked with industry leaders such as Heinz, Coca-Cola, Tyson, and McDonald's.

Peter Verstrate, Senior Manager, Kalypso. Peter brings over 20 years experience in the FMCG industry holding senior management positions in product development, quality management, production and sourcing. Prior to joining Kalypso, Peter worked for Campofrio Food Group, Smithfield Food, Sara Lee and Ahold. He holds an MSc in food technology from Wageningen University.

Technical Requirements
- PC headset
- PC speakers
- Broadband Connection

Intended audience: Directors of Supply Chain, Operations, Innovation, Research and Development, and Quality in the Food & Beverage and Retail sectors.

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.

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?

In this NDA Approval Process training Webinar learn the guidance and regulations governing FDA's acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials.
Why Should You Attend:
While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such submissions accepted by FDA – mainly in limited therapeutic areas. Given lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, especially generic and 505(b)(2). Due to shortcomings found during site inspections, lack of inspection resources and the general tightening of FDA safety reviews, FDA has started imposing some “unwritten” requirements for the acceptance of such data. This webinar explores these requirements and how you can ensure compliance.
Areas Covered in the Seminar :

• Guidances and regulations that govern the FDA's acceptance of foreign trial data as pivotal data for NDA approval.
• What you can do to ensure compliance.
• Design considerations and requirements for foreign trials.
• Identify which guidances and regulations govern the FDA's acceptance of foreign trial data as pivotal data for NDA approval;.
• Discuss how FDA is implementing these rules and what you can do to assure compliance; and
• Recognize design considerations and requirements for foreign trials.

The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.

The key to a successful audit is being able to communicate how your quality systems assure this state of control.

However, the arrival of an investigator for an inspection can still be an intimidating experience. The inspection can be less traumatic if the site and its personnel are properly prepared for the inspection and the investigator. During this hour presentation, you will find out how to prepare for the inspection and minimize stress, disorder, and any misinterpretation by the investigator during the inspection with careful planning of activities and effective resource development will support a successful inspection.

Why you should attend:

* Recognize the purpose of the inspection
* Learn how to properly communicate with the inspector
* Anticipate what information the investigator can and will request
* Know how to keep the inspection from being an “emotional” event.
* Know what is expected of you and your company
* Learn what not to say or do during an inspection.
* Recognize your audit responsibilities and vulnerabilities
* Identify the internal support system of a successful inspection
* Realize what steps you/your company should take to prepare for a successful inspection

Areas Covered in the Session:

* Expectations of an audit
* Why the FDA conducts inspections
* Pre-planning and preparation activities
* What to do when the investigator arrives
* What documents to have ready and on hand
* Assignments and responsibilities for the inspection
* A review of Inspection Do's and Don'ts
* The Opening and Close-out Sessions
* Actions to take after the inspection is over

Who Will Benefit:

* Site Quality Operations Managers
* Quality Assurance personnel
* Plant Managers
* Manufacturing Superintendents and Managers
* Individuals whose job knowledge and/or expertise may be required during an audit (Subject Matter Experts)

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.

Performance-based agency compensation is certainly about paying only for positive results. But it is also about forming long-term, mutually beneficial client-agency relationships built around common goals.

Date & Time-

September 28, 2010 at 11:00 AM PDT

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

What’s the worst place in an airplane? The middle seat! Why? You’re literally stuck in a rotten place, possibly for a long time, and you can’t do anything about it. Or can you?

Doug Lipp, respected author, speaker and former head of training at Disney University uses the middle seat as a metaphor for what happens to all of us in life ... we get stuck in uncomfortable places. How do you deal with unfortunate situations? When in a situation that you “can’t control,” what options do you actually have?

This entertaining and thought-provoking webinar will address such topics as:

* Creative Problem Solving
* Work-Life Balance
* Customer Service
* Product Development

Join us for this fun-filled, insightful webinar as Doug addresses everything from life-on-the-road horror stories to dealing with organizational change.

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.