Who: Param Singh, vice president of clinical trial management solutions, BioPharm Systems

Adrian Hampshire, managing director, EMEA, BioPharm Systems

Paul Dobrowolskyj, senior consultant, Oracle Health Sciences

What: Webinar: "Business and Operational Risks in Clinical and Safety: Applying Appropriate Technology and Approaches to Mitigate Risk"

All business processes are subject to some level of risk. Key to the long term viability of any company is the critical need to identify the risks, quantify them, minimize them, and have a clear plan for dealing with any residual risks.

Organizations try to mitigate risks by implementing systems that support the company's business processes. Commercial software systems that are available from vendors such as Oracle include many capabilities which, if implemented properly, greatly reduce the risks in the business process.

The implementation of complex systems is, in itself, a risky process. Organizations like BioPharm Systems have been able to use their wide range of experience to develop pre-configured and pre-validated solutions that help reduce the risks during the implementation of a clinical trial management system (CTMS) and a safety system.

This one and a half-hour webinar will provide an overview of business risks related to clinical and safety systems and will illustrate how the risks inherent in implementing complex CTMS and safety systems can be significantly reduced.

When: Thursday, November 17, 2011 @:

7:00 a.m. US Pacific time
8:00 a.m. US Mountain time
9:00 a.m. US Central time
10:00 a.m. US Eastern time
15:00 UK time
16:00 Central European time

Webinar Information: To register for this complimentary webinar, go to: https://cc.readytalk.com/r/bf2hph6dutcu

This webinar will help you understand the current quality and regulatory paradigm by comparing and analyzing ICH-Q10 Pharmaceutical Quality System and the FDA’s Quality Systems Approach (FQSA) to Pharmaceutical GMPs.

Description
Why Should You Attend:

The ICH and FDA guidance documents on Pharmaceutical cGMPs stress the importance of management's responsibility to meet customer needs by encompassing quality improvement through quality by design (QbD), risk management, process control, and user feedback and experience.

This new paradigm forces industry leaders as well as the FDA to rethink their roles in this dynamic regulatory-business environment. Here, quality principles trump the dictates of compliance. If your company fails to respond to this new calling, it may not be able to compete effectively in the marketplace. These quality concepts are based on well-known and tested quality principles that have been shown to be effective. While the "new quality" is gaining, the virtues of compliance are declining.

Attend this 4-hour webinar and learn how you can successfully implement the Quality Systems Approach in your operations. Understand how you can be an active and positive force in driving this paradigm change at your organization.

Areas Covered in the Seminar:

The current quality and regulatory paradigm.
The FD&C Act established the requirements for safety and effectiveness.
Current regulations have failed to ensure safety and effectiveness objectives.
Definition for commonly used terms.
Understanding the battle between compliance and quality.
Cross-functional relationships and their role in achieving quality effectiveness.
The Quality Constitution paves the way to cooperation and teamwork.
Transforming Juran’s Quality Loop/Spiral to the Regulatory Loop.
The Pharmaceutical Lifecycle.
The What, Where, Why, When, and How of FDA Enforcement Status.
Dissecting and Analyzing the FDA’s Quality Systems Approach (FQSA) and ICH-Q10.
Background.
Comparison of Scope.
Comparison of Purpose and Objectives.
Comparison of Contents.
Overview of Similarities between FQSA and ICH-Q10.
Overview of Differences between FQSA and ICH-Q10.
Comparisons to FDA, ISO, ICH, GHTF, and other regional regulations.
Summary Overview of Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulation and ICH Q10-Pharmaceutical Quality System.
Understanding and Applying the Common Quality System Concepts Embodied in These Standards.
People, Leadership, and Management Responsibility.
The Importance of Resource Management.
Building and Organizing the Quality System.
Achieving a State of Control.
Knowledge Management.
Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System.
Documenting Policies, Procedures, and the Quality Manual.
Achieving Product Realisation (Realization).
Lifecycles Defined.
Importance of Design To Establish the Master Records.
Risk starts with Design.
Technology Transfer.
Facilities and Equipment.
Material Controls.
Control of Outsourcing.
Process Control’s Dependency on Change Control.
Evaluation & Monitoring Activities.
Maintaining the Quality System Through Management Review and Internal Auditing.
Corrective and Preventative Action.
Technology Transfer.
Continual Improvement.
Six System Inspection Model.
Question & Answer, & Discussion.
Learning Objectives:

Discuss the current quality vs. compliance paradigm.
Explain & discuss the background , purpose and ,objectives for the Food & Drug Administration' s issuance of “The Quality Systems Approach To Pharmaceutical Good Manufacturing Practices” guidance and the ICH's issuance of ICH-Q10, Pharmaceutical Quality Systems.
Translate the terminology used in these guidances into practical and well understood, quality practices and concepts . Such terms as Quality by Design (QbD), Product Realization, Risk Management, Continual Improvement, Management Review, CAPA, will be studied and discussed.
Discuss the organization and content between the documents so that similarities and differences may be studied in order to implement these concepts effectively, efficiently, and without duplication.
Provide established tools that may be used to implement these quality practices discussed in these guidances.
Explain quality and regulatory phases as they relate to the pharmaceutical lifecycle.
The Enforcement What, How, When, and Where of these guidances.
Who Will Benefit:

Because these guidance documents focus on management's responsibility to organize for quality and manage resources, all functions are impacted directly or indirectly. Therefore , all departments would benefit from the seminar. Below is a list of functions that would benefit from attending:

Quality Organization-all levels
All functions of Senior Management
Research and Development
Production (Improve operations by applying these concepts)
Regulatory Affairs
Senior & Junior Management
Purchasing & Finance
Engineering and Maintenance
Instructor Profile:

Howard, enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight.

He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

This CLIA Webinar training will feature an in-depth look at CLIA Waived Testing. It will present the rules and regulations as well as the pros and cons of testing using Waived methods.

Description
Why Should You Attend:
Waived testing is an exciting way to leap into the world of laboratory testing. With over a hundred tests to choose from, every speciality can find testing that will benefit the patients. We will explore the process to become a Waived lab and the many benefits of doing so. We will look at the rules and regulations set forth by CLIA under CMS and how to best meet them. We also will explore the many tests available and how they can benefit your patients. Waived labs make up the majority of laboratory testing taking place in this country and more tests are being added to the Waived category all the time. With less regulatory oversight, ease of use and great re-imbursement, Waived testing is hard to beat. We will also look at the future of Waived testing and where it is headed.

Areas Covered in the seminar:

Waived testing history and origins.
Waived testing CLIA rules and regulations.
Waived tests available and how they fit into your practice.
How to apply for Waived testing and the State's role.
The future of Waived testing and how it affects you
Waived testing pitfalls to avoid.
Who will benefit:

This webinar is designed for any Physician’s office, group practice or small research facility interested in beginning testing of human specimens.
Family Practice, Internal Medicine, Endocrine, Cardiology, ER, Pediatrics or other medical specialty offices
Urgent Care Centers, Walk-in Clinics
Doctors
Nurses
Medical Assistants
Medical Lab Technicians
Instructor Profile:
Barry Craig, Owner and CEO of Laboratory Consulting, LLC. I have 20 years experience in laboratory management with a concentration on physician office labs. I was the POL & Clinic Coordinator for a major Birmingham Health System until 01/01/10. I managed 22, COLA accredited POL’s, half waived, half non-waived. I write the “Ask the Expert” column in Physician Office Resource magazine answering lab related questions monthly. I also have been published in ADVANCE for Administrators of the Laboratory magazine. I taught a class on Lab Consulting at the COLA symposium in Sept, 2009.

Find out how you can be a franchisee with America's #1 Home Buyer!

HomeVestors of America, better known as the "We Buy Ugly Houses" company holds their webinar every Monday evening at 7PM EST presented by our corporate staff in Dallas, Texas. This is an opportunity for you to learn more about the franchise and ask questions.

Here are the instructions to access the webinar, please follow both steps:

Monday, 7PM EST.

Log-in instructions:
Login: www.Readytalk.com
Participant login: 5328013

Dial-in instructions:
1-507-726-3300
Passcode: 11059#

In order to be considered for a franchise, you would be required to complete the "Request for Franchise Consideration" here:
http://www.homevestorsfranchise.com/request_for_franchise_consideration....

Here is a link to the HomeVestors Franchise website: http://www.homevestorsfranchise.com/index.html

And, here is the Power Point presentation that has been converted to video: http://www.youtube.com/watch?v=jjzU7qMQOgo

Sincerely,

Rob Caldwell
Development Agent

HomeVestors of America®
Caldwell Real Estate, LLC
139 Chapel Point Road
Lake Lure, NC 28746
Home Office: 828-625-5836
Cell: 828-989-3785
Fax: 866-705-6393

The franchising information contained in this website is for information purposes only and is not intended as an offer to sell, or the solicitation of an offer to buy, a franchise. We offer franchises only through our Uniform Franchise Offering Circular. Currently, the following states regulate the offer and sale of franchises: California, Hawaii, Illinois, Indiana, Maryland, Michigan, Minnesota, New York, North Dakota, Oregon, Rhode Island, South Dakota, Virginia, Washington, and Wisconsin. If you are a resident of one of these states, we will not offer you a franchise unless and until we have complied with applicable presale registration and disclosure requirements in your jurisdiction.

HomeVestors is a franchise. Each franchise office is independently owned and operated. All HomeVestors' franchise programs are subject to change due to market conditions or availability of funds. Financing programs are not guaranteed by the franchise agreement.

In the current economic and political climate, many organizations face a host of energy-related challenges. With a well-crafted energy management strategy, organizations can reduce operational expenses, comply with impending regulations and appeal to environmentally-conscious patrons­ all without affecting product and service levels.

In this educational webcast, the experts at LPB Energy Management will share best practices to reduce cost and consumption up to 30% by:

Eliminating the “data divide” between groups who receive and pay utility bills and those accountable for lowering cost and consumption.
Maximizing rate reduction opportunities through energy procurement, invoice audit and demand response programs.
Minimizing consumption and provide analysis and reporting to measure program success.