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

FREE webinar - Wednesday, 14 September 9AM UTC

Out of the box, Author-it revolutionises your authoring environment and gives you so many more delivery options. But, if you dig a little deeper and get your hands dirty, you can really make Author-it work for you; give your output a unique look, effectively manage and manipulate your content, and streamline your publishing processes.

Join the free 'Bend Author-it' webinar where you will see how to do magic tricks with Author-it and bend it to your will.

Topics include:

• Custom Titles pages
• XML hacks
• AfterPublish Macros

Who should attend

This webinar is for anyone who is interested in seeing how to push beyond Author-it's out-of-the box functionality.

Register here

Title: Knowing Your Business Is Good PR
Public relations webinar
URL: http://www.prsa.org/Learning/Seminars/view/740/Knowing_Your_Business_Is_...
CTA: Use Your Business Literacy to Communicate With the CEO, Improve the Outcomes of Your Strategies and Tactics, and More.

APR
Date: Thursday, September 22, 2011
Time: 3 p.m.
2 p.m. Central
1 p.m. Mountain
12 p.m. Pacific
Duration: 60 minutes
Member $50 / Non-Member $75

Title: Digital Media and Today’s Digital News Release
URL: http://www.prsa.org/Learning/Seminars/view/463/Digital_Media_and_Today_s...

Public Relations Webinar ; Discover the best way to get journalists to pick up your story
When: Now On-Demand
Thru: August 31, 2011
Duration: 60 minutes

Member $150 / Non-Member $250

Summary
Corrective & Preventive Action (CAPA) systems have been in existence since the dawn of time. When a negative event occurs, one of the first questions is how and why did it happen? Depending on the impact of the event, there is an analysis or investigation of the event to determine all aspects of the "Why" and the "How". Although quite informal, this is a rudimentary CAPA system.

Details

Sometimes, no matter how well controlled, the input of the process fails to produce the expected output. A deviation or nonconformance has occurred. A deviation is defined as a departure from the expected input, in other words, a procedure was not followed, or a specification requirement was not met. A nonconformance, according to Part 820, means the non-fulfillment of a specified requirement. This requirement, like that of a deviation, indicates a procedure was not followed or a specification requirement was not met. When deviations/nonconformities occur, a system must be in place for evaluating the impact on quality, conducting an investigation to determine root cause, and following up to verify the root cause was properly identified .A Corrective and Preventative Action(CAPA) system must be in place to track these events until closeout of the event is completed.

Medical product problems require a stringent and formal CAPA system. The original GMP regulations for devices & drugs were embedded within the regulations. CAPA systems were first formalized for devices in the "Quality Systems Regulation" and for drugs in ICH Q-10, "Pharmaceutical Quality Systems"

The principles of handling deviations and nonconformities are the same for devices and drugs. For devices, the process is well outlined in the regulations. However, for drugs, the requirements are not so defined.

Why should you attend :

The FDA establishment inspection focuses on nonconformities/deviations and CAPA systems because deviations and nonconformities point toward quality system failures. You and your firm must be prepared. However, the need for a CAPA system is much more than a compliance requirement. Combined with investigations, it is one of the most useful tools for analyzing data leading to quality improvements and efficiencies.

This webinar will explore the Event-Investigation-CAPA (EIC) lifecycle and how you can apply it to your operations. This EIC lifecycle will be explained using graphics to explain regulatory requirements and industry practice, These graphics will serve as a model for establishing an effective and practical CAPA system.

By attending this webinar, you will better understand CAPA systems, learn ways to better use or improve your existing system, and begin development and implementation of a new CAPA system.

Areas Covered in the Session ( Objectives & Overview )

Good Manufacturing Practices And Quality Systems.
What do the GMP's Say About Deviations & Nonconformities and CAPA Systems?
The Importance of Master Records
Classifying Deviations and Nonconformities
Analyzing the Event (Deviation or Nonconformity)
Roles & responsibilities
The Deviation-Nonconformity and CAPA Lifecycle
Event
Discovery
Immediate Actions.
Notification of Event.
Establishing the Investigative Team (What function should take the lead?)
Data Collection.
Establishing the Root Cause
Preparing the Report and Conclusion
Approval of the Report
Close-Out & CAPA Entry
Tracking & Follow-Up.
Determining the Effectiveness.
The Next Step
Documentation and Record Keeping
What Will the Computer Do for You?
Review

Who will benefit :

Quality Control Laboratory Manager, Warehousing, Purchasing Managers and Procurement Managers, Laboratory Analyst, Cost Accounting, IT, Documentation Management

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 derives considerable satisfaction from diagnosing quality systems in order to make them more compliant, efficient, and productive. 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.

In this hour long event, learn more about the power of Author-it.

This demo shows you what Author-it does. We cover Author-it terms and concepts, importing existing content, creating new content, creating deliverables, and publishing to PDF, HTML, and more.

Ask questions from the presenter to understand how these tasks might be used in your company. At the end of the hour, you'll see how Author-it can help you be more productive in your content development workflow.

Author-it Software Corporation (ASC) is a world leader in enterprise software for authoring, content management, publishing, and localization.
Its flagship product, Author-it, is an end-to-end content management solution capable of publishing content to multiple deliverables.
Since its release in 1997, ASC has produced five major versions of Author-it, resulting in a robust product built on proven technologies.
Author-it is used in over 50 countries, by over 3500 clients and chosen by Fortune 100 organizations for worldwide deployments, making it one of the world's most popular content management tools.
ASC has offices in San Jose and Newport Beach, California, Dubai, United Arab Emirates, Sydney, Australia and Auckland, New Zealand.
Visit us on www.author-it.com.

This hour long tool-neutral webinar covers identifying your business and workflow needs and how to prioritize them. This should help you understand your workplace and workflow needs when you start evaluating tools.

This demo shows you what's new in Author-it 5.5. Even if you don't know anything about Author-it, the workflow enhancements you see will amaze you.

Author-it Software Corporation (ASC) is a world leader in enterprise software for authoring, content management, publishing, and localization.
Its flagship product, Author-it, is an end-to-end content management solution capable of publishing content to multiple deliverables.
Since its release in 1997, ASC has produced five major versions of Author-it, resulting in a robust product built on proven technologies. Author-it is used in over 50 countries, by over 3500 clients and chosen by Fortune 100 organizations for worldwide deployments, making it one of the world's most popular content management tools.
ASC has offices in San Jose and Newport Beach, California, Dubai, United Arab Emirates, Sydney, Australia and Auckland, New Zealand.

Visit us on www.author-it.com.

"Trust Your Heart: Transform Your Ideas into Income" will inspire you to take your own dreams of owning a profitable business and turn them into reality.

Title: Trust Your Heart: Transform Your Ideas into Income
Series: The Story Behind The Story
Speaker: Marnie Pehrson
Panelists: Dr. Joseph Peck
Date: Tuesday, May 24, 2011
Start Time: 3 pm EDT (Eastern Time), Noon PDT, 9 pm U.K.
Duration: 60 minutes
Cost: Free

http://budurl.com/trustyourheart1

Marnie Pehrson is a best-selling author, speaker and online publicist who helps spiritually-minded entrepreneurs find their place in the world and deliver their messages online. She is the creator of the longest running content directory, IdeaMarketers.com, where you can promote your articles, press releases, information products, videos, audios and expertise. Marnie is also a wife and mother of 6 and the author of 20 fiction and nonfiction titles. If there's truth or talent to be highlighted, Marnie's your girl. Her mission is to help you live yours.

During this webinar, Marnie will share some amazing stories to encourage you to Trust Your Heart to Transform Your Ideas into Income. This includes:

- Her life story
- How IdeaMarketers.com was birthed, how that works, and some of the greatest fruit
- How "Trust Your Heart: Transform Your Ideas into Income" was birthed and how this ties into her mission to you live your mission

Marnie says, "You Have a Message! Let's Get It Out There!"

http://budurl.com/trustyourheart1

This webinar will cover the basics on how to maintain a good Design History File that will help a manufacturer during a regulatory compliance audit

Description
Why Should You Attend:

A Design History File (DHF) is a requirement of QSR 21 CFR Part 820. It is a certainty that in an audit from a regulatory body, information from the DHF will need to be provided. Manufacturer's would be well prepared for audits by regulatory agencies if they know the strengths and weaknesses of their DHF, and remediate as needed, prior to the agency showing up at their doorstep. Virtually every section of the design control requirements specifies information which should be found in the DHF. Manufacturer's need to be aware of what gaps exists between the actual DHF and the FDA's expectation.

This webinar will cover the basics on how to maintain a good design history file that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to take to ensure that the DHF is completed as the design and development process progresses. Additionally, the DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control audit.

Areas Covered in the Seminar:

DHF structures that work well for audits.
Documents that should and should not go into a DHF.
When does a DHF need to be created.
What to look for when auditing a DHF.
How to address issues with the DHF.
The usefulness of the DHF in continuing to maintain the product after launch.
DHF ownership when third parties are involved.
Who Will Benefit:

This webinar will provide valuable assistance to medical device companies in managing their Design History Files. The employees who will benefit include:

R&D Engineers
Quality Engineers
Regulatory Affairs
Quality System auditors
Engineering managers and personnel
Instructor Profile:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry; Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.