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 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.

This webinar will discuss multiple Quality Control Tools used in manufacture of pharmaceutical and biotech products, their purpose, advantages and disadvantages. You will learn how to implement cGMP compliance related to Quality Systems Operations.

Description
Why Should You Attend:

There are a number of Quality Control Tools which have been used in a multitude of global industries. The incorporation of Quality Control Tools in support of the Pharmaceutical Quality System offers manufacturers an effective way to evaluate their operations and achieve a state of control. Failures in achieving the latter frequently result in issuance of observations by regulatory authorities and may lead to additional regulatory actions.

The FDA employs a systems-based approach to inspection, including evaluations of the quality system and the five manufacturing systems, to ensure that the drug, biologics and medical device manufacturers are in a “state of control” and in compliance with regulatory requirements.

The US FDA published a guideline for industry entitled, “Quality Systems Approach to Pharmaceutical cGMP Regulations”. The guideline was published for the purpose of aiding “manufacturers, implementing modern quality systems and risk management approaches” to meet cGMP regulatory requirements. Within the guideline, FDA described a comprehensive quality systems model incorporating the following elements: Management Responsibilities, Resources, Manufacturing Operations and Evaluation Activities. The last element, “Evaluation Activities” focuses upon the topics of data analysis and trending, internal audits, risk assessment, corrective action, preventive action and process improvement.

This webinar will discuss multiple Quality Control Tools (e.g., Graphs, Pareto Chart, Ishikawa/Fishbone Diagram, Control Chart, 5 Why 2 H, Reverse Fishbone) including their purpose, advantages and disadvantages. The application of Quality Control Tools in the performance of data analysis and trending (i.e., stability data, environmental monitoring, rejects, training metrics, etc.) will be described. We will also discuss recent regulatory authority observations associated with the lack of cGMP compliance related to Quality Systems Operations.

Areas Covered in the Seminar:

Understanding the purpose of Quality Control Tools.
Advantages and disadvantages of using Quality Control Tools.
Discuss and provide examples of proactive Quality System “Evaluation Activities”.
How to incorporate Quality Control Tools for a more effective Quality System.
Key cGMP Issues regarding lack of proactive “Evaluation Activities” as cited in Regulatory Authority Inspection observations.
Who Will Benefit:

This webinar will provide information to regulated industry including pharmaceutical, biotechnology & medical devices, responsible for the manufacture of cGMP products. Those functional roles that would derive the most benefit from this webinar include:

QA Managers/Directors
QC Managers/Directors
Quality Systems Personnel
Operations or Manufacturing Managers/Directors
Instructor Profile:

Felicia Ford-Rice, is a Principal Consultant with PAREXEL Consulting, a division of PAREXEL International, specializing in Strategic Compliance. Felicia has over twenty years experience working in Research and Development, Regulatory Affairs and Quality Assurance roles for Academia, the US Government, Vaccine and Pharmaceutical manufacturers. In previous roles she has led the creation of the following quality system elements: deviation/CAPA, investigation, effectiveness checks, management review processes, product disposition/ release, aseptic processing support, change control, product complaints, product recalls, quality agreements, EM trending, APRs, controlled documentation management, internal/external audits, supplier qualification, MRB, CRO/CMO oversight, regulatory authority inspection readiness, anti-counterfeiting communications. Felicia has also trained and directed the GMP, GLP, GCP and regulatory inspection readiness training of multidisciplinary staff, taught graduate courses on Regulatory Affairs and Quality Assurance topics for Northeastern University. She has authored technical reports, co-authored or contributed to abstracts and scientific papers published in peer review journals and presented at scientific symposia. Felicia has also served on the SCDM Editorial Board, and the PDA Annual Meeting Program Planning Committee and currently supports the HBA Membership and Marketing Committees. She is a member of PDA, RAPS, DIA, and HBA and holds a RAC Certification.

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.

This food safety webinar will provide a detailed overview of pathogenic E. coli, their sources and dissemination routes, in addition to means of detection and control

Description
Why Should You Attend:

Recently a further strain of EHEC, E. coli O26, has been classed as an adulterant with consideration of other strains being added to the list.

Pathogenic E. coli can be categorized into 6 main groups with Enterohaemorrhagic E. coli (EHEC), such as the O157:H7 strain being the most significant. There are 73,000 cases of E. coli O157:H7 reported annually within the US each year. E. coli O157:H7 was identified as a food-borne pathogen in 1982 and since this time further EHEC strains have been implicated in food-borne illness. Previously, only E. coli O157:H7 was classed as an adulterant which essentially means that if the strain is found, the food product must be recalled then destroyed or diverted for further processing. The presence of E. coli O157:H7 in ground beef has led to some of the largest recalls in history and hence places a large financial burden on the industry.

Given that the pathogenic E. coli poised to become an even more significant pathogen to the food industry in the near future, this webinar will provide a detailed overview of pathogenic E. coli, their sources and dissemination routes, in addition to means of detection and control.

We will also review the regulations around pathogenic E. coli and future trends.

Areas Covered in the Seminar:

Evolution of different pathogen Escherichia coli.
Mode-of-illness and virulence factors.
Sources and epidemiology.
Food-borne illness outbreaks linked to pathogenic E. coli.
The emergence of non-O157 EHEC.
Diagnostics for pathogenic E. coli.
Regulations around pathogenic E. coli.
Learning Objectives:

Evolution of pathogenic E. coli including E. coli O157:H7 and other relevant EHEC strains
Mode by which different E. coli types cause illness
Sources and routes of dissemination
Diagnostic tests for pathogenic E. coli detection
Interventions to control pathogenic E. coli
Future trends
Who Will Benefit:

QA and QC Managers
Production Managers
Food Scientists and Technologists
Laboratory Managers
Food Safety Personnel
HACCP Coordinators
Government food inspectors
Sanitation Managers
Corporate and Plant Microbiologists
Processing Engineers
Operations Supervisors and Managers
Instructor Profile:
Dr. Keith Warriner, is currently an Associate Professor within the Department of Food Science at University of Guelph, Canada. Dr. Warriner received his BSc in Food Science from the University of Nottingham, UK and PhD in Microbial Physiology from the University College of Wales Aberystwyth, UK. He later went on to work on biosensors within the University of Manchester, UK and subsequently returned to the University of Nottingham to become a Research Fellow in Food Microbiology. He joined the Faculty of the University of Guelph in 2002.

During the last fifteen years in the field of microbiology and food safety research, Dr. Warriner has published more than 100 papers, book chapters, patents, and conference abstracts. He has broad research areas encompassing development of decontamination technologies, biosensors for biohazard detection, and more fundamental research on the interaction of human pathogens with plants. One notable research accomplishment was the development of a decontamination treatment for sanitizing seeds destined for sprout production and a further process based on Advanced Oxidation Process for inactivating pathogens on fresh produce. Current research in the area is focused on developing biocontrol strategies based on using a combination of antagonistic bacteria and bacteriophage to reduce levels of human pathogens at the primary production stage.

This food safety webinar addresses components of Good Manufacturing Practices that packaging material suppliers should follow for adherence to both regulatory and voluntary standards protocols

Description
Why Should You Attend:

Food safety concerns in the supply chain arte driving global requirements for good manufacturing practices (both legal and contractual) in the way packaging material suppliers manufacture and market their products. Packaging suppliers must be ready to address both procedural and material changes in their operations and food processors must know what retailers will require of them in the case of a food safety alert.

Food packaging producers for products sold in both the US and European Union are legally obligated to use “good manufacturing practices” (gmp) in producing their products. Additionally, contractual requirements for certifications to international food safety standards are compelling virtually all food packaging material suppliers to develop, document and practice formal gmp procedures in their facilities. Recent EU initiatives have spelled out expectations for gmp compliance much more clearly than have US regulations.

This webinar addresses the components of gmp programs for adherence to both regulatory and voluntary standards protocols. Attention is given to ancillary components such as training, record keeping, internal auditing and corrective actions. Users of food packaging materials will learn what to expect of suppliers as part of their own gmp programs, and producers will understand how to protect themselves and their supply chain from ruinous disruptions.

Areas Covered in the Seminar:

Food processing facility inspections.
Sanitation standards for producing food packaging materials.
Compliance expectations, legal and contractual.
EU and US regulatory standards.
Packaging material traceability.
Product recall response.
Third-party certification standards for packaging.
Training, record keeping, internal audits, corrective actions.
Learning objectives:

The webinar provides clear direction on legal and (evolving) contractual expectations for facilities manufacturing food packaging materials and packaging material users who wish to audit suppliers. Special attention is given to traceability of materials used to manufacture the packaging and required record keeping .

Free handouts:

Checklist of basic gmp procedures at food packaging material producers for producers to observe and users to use for auditing.

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.

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

Please join Wall Street Network (WSN) and learn how WSN Insight, our Knowledge Management Application for SharePoint, can boost efficiency and provide a simple collaborative platform for any corporate environment.

This game-changing tool will allow you to leverage the intelligence and innovation of your staff like never before!

Date: 4/20/2011 Time: 11:00 AM

How to Grow Your Business by Outsourcing Time Consuming Work to Virtual Assistants

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

To Invite Your Friends Go To:
https://webinar.spreadable.com/

Date: Thursday, March 24, 2011
Time: 3:00 PM - 4:00 PM EDT

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

-- 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

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

1) My Special Offer
2) You will also get to Ask Question Live and Get Answers

Learn best practices for forecasting and scheduling and improve the performance of your call center.

Optimal call center performance starts with an accurate schedule. Chuck Ciarlo who successfully owned and operated multiple call centers, will talk about:

- Scheduling of call and non-call activities
- Scheduling full/part time and flexible shifts
- Improving schedule adherence
- Scheduling multiple channels (phone, email, etc.)

Register now to reserve your spot.