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

The Content Trends Survey results are interesting and relevant to all those involved in content development. Attend this webinar to find out what the results are and what they mean to you. Find out what the industry trends, needs, and wants are in this one hour webinar.

We asked about the following topics:

• New tools requirements/issues
• Current and near future publishing output needs
• Localization
• Staffing sizes
• Information about industry and current role in the company

This webinar will be recorded for later viewing. If you cannot attend because of the time or date, sign up anyway. You should get a link to the recording about 24 hours after the webinar is over.

This environmental monitoring training will review the best practices for setting environmental monitoring alert and action levels for viable and non-viable data including product bioburden. In addition this webinar will address the responses/actions that should be taken when an excursion in the alert or action level occurs.

Description
Why Should You Attend:
Medical products are manufactured in environments that are designed to control the level of viable and non-viable particulate and these environments must be monitored to establish that the control measures are continuing to perform acceptably including the impact to product bioburden. You need to establish appropriate limits for ongoing monitoring so it is critical that you know how to set these limits. But once these limits have been set it is also critical for you to know what actions need to be taken to determine if there is product impact or other implications to the manufacturing process when the monitoring results exceed these defined limits.

This presentation will review best practices for setting bioburden/environmental monitoring limits and the various items that should be included in an investigation to determine the cause of a limit excursion for both viable and non-viable excursions. It will provide guidance on how to determine the who, what, when, where so that you can figure out the how and why. It will also provide guidance on how to write your investigation story so that manufacturing and regulatory bodies will be able to follow the investigation coming to the same how and why that you did.

Areas Covered in the Seminar:

Best practices for monitoring and establishing limits.
Product bioburden
Viable particulate
Non-viable particulate
Do I really need to investigate if the alert limits are exceeded?
Investigating an alert limit excursion.
In the environment
On the product
Who to investigate.
What to investigate.
When - what is the appropriate timeline to investigate.
Where should you look.
Documenting the investigation story.
Who will benefit:

This webinar will provide valuable information to all companies that manufacture medical devices in environments that are controlled and monitored for viable or non-viable contamination.

QA personnel
Manufacturing Supervisors
R&D
Instructor Profile:
Gerry O’Dell, is President of Gerry O’Dell Consulting, a consulting firm based in the United States with clients around the world. Gerry O’Dell consults to medical device and pharmaceutical companies related to all the major sterilization methodologies, microbiology, environmental control, laboratory compliance, failure investigation, etc. Her varied background includes extensive knowledge in sterilization technology, laboratory management, microbiological testing (including pyrogens), decontamination of returned goods, and compliance.

Prior to starting Gerry O’Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. Before becoming a part of Johnson & Johnson Medical, Gerry was Manager of Sterilization Services at Critikon, Inc where she started as a Lab Technician. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over twenty-five years of experience in the medical device industry.

Gerry is a member of the Association for the Advancement of Medical Instrumentation (AAMI) and actively participates in the Sterilization Standards Committee activities. She is currently Co-Chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and a member of the U.S. Sub-TAG for ISO/TC 198/WG 1. She is also a member of the Sterilization Residuals, Radiation Sterilization, Sterility Assurance Level (SAL), Compatibility of Materials Subject to Sterilization, and Microbiological Methods Working Groups; actively participating in the development of several standards and guidance documents. Gerry is a Registered Microbiologist with the National Registry of Microbiologists in the area of Consumer Products & Quality Assurance. She is also a member of the American Society for Microbiology (ASM), American Society for Testing & Materials (ASTM), and PDA.

How to Work Less & Earn more Income by Outsourcing all your Time Consuming Work to Virtual Assistants!

Date: Thursday, April 14, 2011
Time: 3:00 PM - 4:00 PM EST

Learn Everything You Need to Know about Finding, Training & Working with Virtual Assistants!

To Register For Webinar Go To:
http://www.HireYourVirtualAssistant.com/webinar

-- What You Will Learn during the Webinar: --

1) The Mindset behind Outsourcing and Automation
2) The Benefits of Outsourcing and Automation
3) How to find the Right Virtual Assistants
4) Hiring and creating your Virtual Team
5) How to Set up the Systems and Processes ready for automation
6) How to Manage your Virtual Assistants
7) How; Outsourcing + Automation + Virtual Assistants = Your Freedom!
8) What Income Producing Activities to Focus on and what to Delegate to you Virtual Assistant
9) How Determine How Much Your Time is Worth
10) How to Make Money By Delegating task to Virtual Assistants
11) You will also get to Ask Question Live and Get Answers

-- Bonus: Just for Attending the Webinar You will get: --

1) My Special Offer
2) My Free eBook titled of my EBook "The Entrepreneur's Guide to Running a Business in the Cloud"

Intended audience:
Entrepreneurs, CEOs, Small Business Owners, Managers

In this Bioanalytical methods validation understand the Clear, Consistent and compliant approaches for instrumental, ligand binding, and cell based methods.

Description
Why should you Attend:
Bioanalytical method validation includes various procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use. It is essential to employ well-characterized and fully validated bioanalytical methods to yield reliable results which can be satisfactorily interpreted.

This webinar will discuss the best practices of Bioanalytical method validation, including components of a validation, how to include critical reagents comparison, selectivity experiments, assessment of stability. Concept of plate and experiment separation. Importance of communication between the development and the validation labs, accuracy of transfer documents (SOPs). Predicate rules, support of clinical and non clinical sample analysis.

Understand - Is validation a regulated activity? When to pull the trigger for validation? Is a stable label internal standard always the best choice? Importance of suitability testing. Value of including critical reagents testing and suppliers. The limits of an assay and where they come from.

Areas Covered in the Seminar:

FDA regulations and guidelines.
Learning from the Crystal City FDA/Industry conference report.
Phased approach for validation during drug development
Logistics of validation
Development of a master plan and SOP for validation
Preparation and use of reference standards and equipment
Defining parameters and acceptance limits
Defining validation experiments
Documenting and archiving raw and source data
Considerations for Microbiological and Ligand-binding Assays
Working with QC samples for quantitative results
To revalidate or not after method changes
Transferring and using the method to routine
Using computers for automated method validation
Documentation for the FDA and other agencies
Who Will Benefit:

Managers and analysts in bioanalytical laboratories
Managers and analysts in forensic and toxicological laboratories
QA managers and personnel
Validation specialists
Training departments
Documentation department
Consultants
Bioanalytical scientists
Pharmacokinetic specialists
Biotech R&D staff
Clinical research associates
Regulatory staff
Outsourcing Professionals
Biopharmaceutical Consultants
Instructor Profile:
Edward O’Connor, PhD, is a consultant supporting Bioanalytical method development, validation and application to non clinical and clinical sample analysis. His background includes directing these efforts at a number of CROs including Tandem Labs, TherImmune, Covance, Oread and Mason Research. In addition, Dr. O’Connor directed, or managed validation efforts and samples analysis at Elusys, Biogen and MedImmune.

This exciting hour-long event led by Paul Trotter, visionary CEO of , examines how the role of business content development and management is changing in large and small businesses around the world.

The past 10 years of content development have seen seismic shifts in who creates content, and how and where it is created. Business has gone from silo-ed, generic content developed as an afterthought to a world wide web of users who expect more and faster. Regardless of the tools used, companies must meet the content demands of customers and reduce the costs of developing and managing business content.

This webinar covers key future trends in content development. Among them:
* Centralized authoring
* Cloud computing
* Dynamic customized online content
* Community engagement

Authors, managers, directors, or vice presidents involved in content development, management, support, or budgeting should attend this event.

Paul Trotter has spent nearly 20 years on the leading edge of the business of content development and management. He brings his years of experience in the industry to this webinar, showing attendees what they need to know now and what they need to prepare for the future.
The webinar will be recorded and made available on the Internet. Those signed up will receive a link to the recording the next business day.

Are you familiar with the major export documents that can help you complete a successful transaction? Join me in a presentation discussing Export Documents and Shipping.

At the end of this webinar you should be able to:

• Identify the common documents used in an export transaction.
• Learn the difference between Schedule “B” and Harmonized Tariff System (HTS).
• Identify export key shipping costs.
• Understand the basics of Incoterms-2010.

This webinar will benefit:

• Those with a product suitable for export, but no previous exporting experience.
• Those with some export experience, but are seeking to expand their exporting knowledge.
• Entrepreneurs and trade consultants.
• Professional organizations - trade and industry associations, Chamber of Commerce’s.
• Government agencies - foreign trade agencies, business development centers.

No password, no dial in required use of web browser only. You may e-mail your questions in advance to stcintL@stcinternational.us

Event Date: Friday, April 5, 2011

Event Link: http://my.dimdim.com/stcintL

Time: 11:00 AM PST - 12:00 AM MST - 1:00 PM CST - 2:00 PM EST

For future webinar schedules please go to http://www.stcinternational.us

Export 101 Webinars

Export 101: Practice and Fundamentals
Export 101: Export Documents and Shipping
Export 101: Export Payments and Financing
Export 101: Export Marketing

Import 101 Webinars

Import 101: Importing into the U.S.
Import 101: Import Payments and Financing
Import 101: Import Documents and Shipping
Import 101: Marketing Imported Products

Are you familiar with international payment methods and financing options that are available for you when importing a product? What are the potential risks? Join me on this 3nd of a series of 4 Importing 101 webinars.

At the end of this webinar you should be able to:

• Identify international payment methods and risks associated with each payment method..
• Learn when to use documentary collection and its advantages.
• Identify letter of credit steps and discrepancies.
• Understand public and private financing options.
This webinar will benefit:
• Those with a product suitable for import, but no previous import experience.
• Those with some import experience, but are seeking to expand their importing knowledge.
• Entrepreneurs and trade consultants.
• Professional organizations - trade and industry associations, Chamber of Commerce’s.
• Government agencies - foreign trade agencies, business development centers.

No password, no dial in required use of web browser only. You may e-mail your questions in advance to stcintL@stcinternational.us

Event Date: Friday, March 22, 2011

Event Link: http://my.dimdim.com/stcintL

Time: 11:00 AM PST - 12:00 AM MST - 1:00 PM CST - 2:00 PM EST

For future webinar schedules please go to http://www.stcinternational.us

Import 101 Webinars

Import 101: Importing into the U.S.
Import 101: Import Payments and Financing
Import 101: Import Documents and Shipping
Import 101: Marketing Imported Products

Export 101 Webinars

Export 101: Practice and Fundamentals
Export 101: Export Documents and Shipping
Export 101: Export Payments and Financing
Export 101: Export Marketing

Are you familiar with the payment options that are available for you when importing a product? What financing facilities are available for importers? Join me on this 3nd of a series of 4 Importing 101 webinars.

Free Import Payment Methods and Financing

At the end of this webinar you should be able to:

• Identify international payment methods and risk associated with each method
• Learn when to use documentary collection and its advantages.
• Identify letter of credit steps and discrepancies.
• Understand public and private financing options.

This webinar will benefit:

• Those with a product suitable for import, but no previous import experience.
• Those with some import experience, but are seeking to expand their importing knowledge.
• Entrepreneurs and trade consultants.
• Professional organizations - trade and industry associations, Chamber of Commerce’s.
• Government agencies - foreign trade agencies, business development centers.

No password, no dial in required use of web browser only. You may e-mail your questions in advance to stcintL@stcinternational.us

Event Date: Friday, March 22, 2011

Event Link: http://my.dimdim.com/stcintL

Time: 11:00 AM PST - 12:00 AM MST - 1:00 PM CST - 2:00 PM EST

For future schedules please go to http://www.stcinternational.us

In this hour long event, learn more about the power of Author-it Localization Manager. Author-it Localization Manager reduces localization costs by helping you send the right content to translation. Don't pay for translation you don't need or, worse, only send part of the content that needed to be translated.

Author-it Localization Manager uses XML to seamlessly integrate with existing localization processes and translation memory tools. Author-it Localization Manager maximizes reuse by using content directly from its single source database. This reduces repeated translations, so translators only work on new and modified content.

* Integration with leading Translation Memory tools
* Substantially reduce post-translation desktop publishing
* XML-enabled technologies
* Word count audit facilities
* Automatic and manual approval facilities

Benchmarked projects show substantial savings in localization costs and translation word counts.