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

Webinars are a low cost way to generate qualified sales leads. Delivered as educational marketing, they also position you as an authority in your field, creating respect and instilling trust in your audience. Bottom line, it gives your sales efforts a running start.

Webinars are a low cost way to generate qualified sales leads. Delivered as educational marketing, they also position you as an authority in your field, creating respect and instilling trust in your audience. Bottom line, it gives your sales efforts a running start.

Webinars are a low cost way to generate qualified sales leads. Delivered as educational marketing, they also position you as an authority in your field, creating respect and instilling trust in your audience. Bottom line, it gives your sales efforts a running start.

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 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.

Go beyond the basics in this advanced-level Webinar that provides in-depth information about getting the most from your webinar delivery initiatives.

Most everyone has attended or delivered at least one webinar in their career. This webinar is for those already using webinars but are either spread too thin to get the maximum ROI from their leads or are looking for advanced techniques and low cost alternatives to delivering professional and timely webinars without having to utilize additional in-house resources and staff.

In this 45 minute webinar, learn how to get the most from your webinars, including:
Effectively using social networks to create a buzz about your programs to deliver more registrants and interact in real-time with participants

Unique ways to qualify the audience before, during and after the webinar (without them knowing)

The most effective methods of following-up with registrants and tips to create an engaging course of action

Tips on using outside vendors to do most of the work and make you look like a hero
All attendees will receive a FREE “Webinar Resource Kit” with examples of polling questions, email invitations, follow-up emails and free webinar promotion sites.

About the Presenter:
Don Cameron, marketing strategist and founder of Interactive Telesis and ConferTel, has helped hundreds of organizations generate non-dues revenue by delivering educational webinars to their members in addition to helping businesses use an educational marketing approach to cost-effectively generate qualified sales leads.

This 6-hr training will focus on important microbial issues with pharmaceutical water systems and provide proven solutions for microbial control. Attendees will learn effective sanitation and validation approaches to successfully control biofilm in water systems.

Description
Why Should You Attend:
This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control. It also details how to validate that control by determining the operations and processes that logically must be evaluated in pharmaceutical water and steam systems during the validation exercise in a manner that will please FDA.

Finally, and perhaps most importantly, attendees will learn how to institute simple sampling, monitoring and microbial control levels that will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes.

In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, responses to microbial excursions, root cause investigations, or regulatory interactions, you cannot afford to miss this invaluable training as well as the tips, tricks, and kernels of wisdom that this all-day webinar will give you.

Duration:

6 hours of instruction, one hour lunch, and short breaks as they fit into the schedule.

Agenda (times Eastern)

10:00am (7am Pacific)-11:30 Module 1: Biofilm: Understanding What Makes Water Systems Have Microbial Problems (1:30)
11:30-1:00pm Module 2: Successful Sanitization and Microbial Control Approaches for Pharmaceutical Water Systems (1:30)
1:00-2:00 Lunch hour
2:00-3:30 Module 3: Logical and Rational Water and Steam System Validation (1:30)
3:30-3:45 Afternoon break
3:45-5:15 Module 4: Reducing Microbial Excursions and Improving Investigation Outcomes (1:30)
5:15-5:30 Q&A
Syllabus:

1. Biofilm: Understanding What Makes Water Systems Have Microbial Problems (1:30)

Interactive discussion that presents the basics of biofilm development and the mechanisms behind its detrimental effects on water systems and why it is so hard to control

Common biofilm examples
Biofilm basics and how it develops
Biofilm organism types in high purity water
Biofilm impact on “active” surfaces
Environmental resistances of biofilm
Biofilm impact on purification unit operations
Debunk a few water system myths
2. Successful Sanitization and Microbial Control Approaches for Pharmaceutical Water Systems (1:30)

Interactive discussion that presents the reasons why sanitizations sometimes fail, the properties of commonly used sanitants, their relative efficacy, and how to use them.

Material and construction limitations
Continuous vs intermittent sanitization
The importance of biofilm removal
How sanitants work (or don’t work)
When to sanitize
Troubleshooting sanitization problems
3. Logical and Rational Water and Steam System Validation (1:30)

Interactive discussion of the fundamentals of water system validation with emphasis on what must be done in advance before validation commences as well as the typical content of each stage in the process, how lab water system validation can (and usually should be) different from manufacturing water systems, and whether using packaged waters is a reasonable alternative to a water system for a small volume user. This module also presents the basics of Pure Steam systems validation and what attributes are appropriate to validate

Why validate a water system?
What you should know and do before you validate
Figuring out what you should validate
Validation elements and phases
Minimum validation expectations
What happens after the honeymoon is over
Is validation ever really over?
Special considerations for lab water systems
Packaged water options
Pure Steam specification & validation considerations
Pure Steam testing & troubleshooting considerations
4. Reducing Microbial Excursions and Improving Investigation Outcomes (1:30)

Interactive discussion of how the use of more thorough sampling directions, appropriately set microbial control levels and specifications, and appropriate test controls and environmental monitoring during testing and sampling will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes.

What are excursions?
Water system dilemma: process control or quality control (utility or raw material), or both
Intended roles of Alert/Action Levels and Specifications
Investigation, necessary and often fruitless
Excursion responses and impact
Criticality of valves, hoses, & outlet flushing
Diagnosing the source of the problem
Minimizing unnecessary excursion responses through best practices
Who Will Benefit:

Engineers responsible for water system design and fabrication
Maintenance personnel responsible for water system maintenance and sanitization
Microbiological personnel involved in collecting and testing water system samples
Validation personnel involved in writing and executing water system validation protocols
Quality Assurance professionals involved in deviation investigations and oversight/approval of all other water system activities as well as those involved in defending water system issues to regulatory investigators who may or may not be water experts themselves
Regulatory Affairs professionals involved in describing water and water systems in regulatory filings and also those involved with regulatory inspections
Managers and supervisors of all these disciplines who need to understand what makes water systems unique design, control, monitoring, validation, and investigative challenges.
Instructor Profile:
T.C. Soli, Ph.D. is President of Soli Pharma Solutions, Inc, with lecturing, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 31 years of pharmaceutical experience as a consultant and with DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has authored many articles and chapters in books and industry guides published by USP, PDA and ISP

In this Food safety training learn about Food preservation, traditional heat treatment, emerging food processing technologies, sterilization, shelf stable products, low acid foods, US FDA and USDA regulations, Health Canada, new regulatory terms and definitions, novel foods, high hydrostatic pressure, microwave heating, irradiation.

Description
Why Should You Attend:
Sterilisation unit operation is directed towards achieving shelf stability or commercial sterility through microorganisms removal or inactivation including spores. Traditionally, the food industry used heat to sterilize foods. In current times, where the role of the consumer has become leading and necessary, food production systems are no longer supply-driven but become more demand-driven. As a result of consumer demands for foods that are fresher, more natural, or minimally processed and additive-free, new physical methods of treatment are emerging for shelf-life extension and are under broad development.

Essential terms and definitions of sterilization process in the production of low acid foods (LAF) will be presented. In addition, general approaches for the establishment of sterilization process using traditional thermal and emerging techniques will be discussed.

Buy : Alternative Food Preservation: Pasteurization

Learning Objectives:

Learn about new technologies that can be used for sterilisation and requirements for process design.
Assist to make the right choices to satisfy modern society requirements for safe and healthy products.
Understand the new regulatory terms and definitions.
Understand the specific emerging technologies that are the best fit for different categories of foods.
Areas Covered in the Seminar:

Food preservation technologies.
Food safety.
Low acid foods.
Traditional thermal technologies .
Advanced thermal technologies.
Regulatory terms and definitions.
Sterilization definition and techniques.
Emerging food processing technologies.
High pressure.
Microwave heating.
Packaging.
Process required microbial log reduction.
Food Safety Objective.
Safe process design.
Who Will Benefit:

Quality Assurance Managers
Production Managers
Laboratory Managers
Food Safety Personnel
HACCP Coordinators
Government Food Inspectors
Sanitation Managers
Corporate and Plant Microbiologists
Processing Engineers
Operations Supervisors and Managers
Food Technologists
Instructor Profile:
Dr. Tatiana Koutchma, is a Research Scientist in Food Processing in Agriculture and Agri-Food Canada (AAFC), Guelph Food Research Center where she leads research in food safety engineering. Before she joined the AAFC, she was an Associate Professor at the National Centre for Food Safety and Technology (NCFST) at the Illinois Institute of Technology in Chicago where she had taught courses in food processing and engineering. She received her doctoral degree in Food Process Engineering at Moscow State University of Food Production. Since 1990, she has worked in academia and government research programs, collaborating with leading food companies. Her main research focus is application of emerging processing technologies like UV light, microwave heating and high hydrostatic pressure for improved food safety, security, shelf life and product acceptability. She also initiated a research program on UV pasteurization of fresh juices and other liquid ingredients.

Dr. Koutchma is a member of the Editorial Board of the Journal of Food Processing, Food, and Bioprocess Technology; a member of the Innovative Technologies Board of PepsiCo; is an invited speaker at international symposiums and congresses; and, chairs conferences and society sections. Since 1998, she has published over 50 manuscripts and book chapters on a wide range of food processing related topics. In 2009 she completed a book on the application of UV technology for foods called “Ultraviolet Light in Food Technology: Principles and Applications”.

This webinar addresses new test methods for quantifying migration of Printing inks on food packaging materials into the packaged food and how they affect food safety law compliance.

Description
Why Should You Attend:

Packaged food worth millions of Euros has been recalled in Europe over the past four years as a result of the transfer of printing ink chemicals from the printed layer of packaging material into the packaged product. EU authorities have responded with new regulations and procedures intended to prevent such contamination. The US is likely to follow.

In the US, users and producers of food packaging are responsible for insuring that no chemicals from printing inks migrate into the packaged product. With basic testing protocols for demonstrating that chemicals from these inks do not migrate into packaged food now established through this European initiative, food packages must deal with a new scientific standard for meeting their no-migrate standard.

This webinar will present the methods and guidelines for surrogate food simulants in force now in Europe, with an eye towards their use in compliance with US food safety law.

Areas Covered in the Seminar:

Food processing facility inspections.
Indirect food additives.
Migration into food.
Migration testing and modeling.
Food simulants for migration experiments.
Packaging material traceability.
Product recall response.
Good manufacturing practices.
Surface-print ink offset mechanisms.
Who Will Benefit:

Personnel responsible for HACCP, food safety procedures, FDA compliance, product traceability and safety audits at food processing facilities
Members of the Institute of Food Technologists and American Society for Quality involved in food safety and quality assurance
Packaging engineers at companies using or supplying food packaging material
Instructor Profile:

Tom Dunn, has over thirty years experience in designing food packaging materials and operating food packaging facilities in compliance with local, state, Federal, and International safety regulations. He is past Chairman of the Flexible Packaging Association Technical Committee and the Flexible Packaging Groups of the Society of Plastics Engineers and the Technical Association of the Pulp and Paper industry.

He was an active member of the UV/EB curing industry’s committee that submitted its Food Contact Notification Application to the US FDA.

His undergraduate and Master’s degrees are from Yale University.