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 FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.
 
Areas Covered in the seminar:

• Outline of FDA regulations as applied to software.
• Review of FDA software validation requirements.
• Why validation makes good business sense.
• The 6 Most Common Problems in FDA Software Validation & Verification.
• Strategies on how to avoid the most common problems.
• Advice on successful validation project staffing.

Who will benefit:
This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:

• System owners - responsible for keeping individual systems in validation
• QA / QC managers, executives and personnel
• IT / IS managers and personnel
• Validation specialists
• Software quality reviewers
• Consultants

 
Note : Use this promocode(111087) to get 10% Discount,Valid till Dec 20th.
 
 
 

 This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests.
 
Areas Covered in the Seminar:

• Quality Assurance vs. Quality Assessment: Why the Change?
• The Three Phases of Testing.
• Quality Assessment Systems That Work.
• Quality Control: Principles and Practice.
• QC for Waived Testing: Is Minimum Enough?
• QC Formulas and Their Use.
• Why QC and QA are linked processes.
• Measurement indicators for QA.

Who Will Benefit:
This webinar will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests.All automated non-waived systems fall under these regulations. Employees who would benefit include:

• Chemistry and special chemistry supervisors and techs.
• Hematology and coagulation supervisors and techs.
• Blood bank supervisors and techs.
• Microbiology (automated) supervisors and techs
• Medical Technologists (MT)
• Medical Laboratory Technicians (MLT)
• Laboratory Directors
• Multiple Clinical Competency Technicians (MCCT)
• Clinical Lab Scientists (CLS)
• Point of Care (POC) Coordinators

 
Note : Use this promocode(111087) to get 10% Discount,Valid till Dec 20th.
 
 
 

 This OSHA webinar will specifically evaluate the topic from the viewpoint of a California facility identifying and explaining requirements of the California Fire and Building Codes as well as California OSHA.
 
 
Learning Objectives:
At the conclusion of the module, students should be able to:

• Define a flammable liquid.
• Understand in general terms the Code and regulation limitations on use and storage of flammable liquids in their processes.
• Gain familiarity with key topics such as electrical area classification, ventilation, and listing of containers.
• Gain familiarity with generally accepted industry practices to properly use flammable liquids in their processes.

Areas Covered in the Seminar:
Flammable/Combustible Liquid Classification (California Fire Code (CFC))

• Flammable Liquid Storage and Use Allowances (CFC and California Building Code (CBC)).
• Flammable Liquid Storage and Use Area Requirements (CBC, CFC, California Mechanical Code (CMC)).
• Flammable Liquid Storage and Use Area Classifications (California Electrical Code (CEC)).
• Overview of applicable national standards such as UL listings and NEMA ratings.

Who Will Benefit:

• Staff working with flammable liquids
• Engineers designing and implementing processes using flammable liquids
• Safety staff seeking an increased familiarity with compliance issues associated with flammable liquids
• Managers or Supervisors of areas using process flammable liquids

 
Note : Use this promocode(111087) to get 10% Discount,Valid till Dec 20th.
 
 
 

 This OSHA inspection webinar will cover aspects of an OSHA inspection from how establishments are targeted, how to limit the scope of an inspection or investigation, how not to self-incriminate, and when and how to appeal.
 
Areas Covered in the Seminar:
The following general topics will be covered within the 10 Mistakes agenda:

• The OSHA jurisdiction that will inspect an establishment. About half of the states are under federal OSHA jurisdiction, and the remainder subject to independent state OSHA programs.
• Understanding the “probable cause” for the inspection is the key to limiting the scope of an inspection
• Understanding “consensual inspection” is the key to exercising the employer’s rights during an inspection.
• Effective safety program document management can avoid smoking guns.
• A late or ineffective appeal (not knowing defenses) can exacerbate the outcome of an inspection.

Handout Materials:
Webinar will include examples of forms, documents, photographs, and links to sources of standards and other inspection-related information.
Who Will Benefit: 
This webinar is designed to be sufficiently basic that non-safety professionals and lawyers, like managers, HR personnel, facility managers, and others assigned to handle safety and health matters and OSHA inspections.

• Safety professionals
• Consultants
• Insurance loss control advisors
• Attorneys not practicing OSHA law will find tricks of the trade and strategies revealed in the webinar

 
Note : Use this promocode(111087) to get 10% Discount,Valid till Dec 20th.
 
 
 

 The OSHA training webinar teaches the basics in practices and procedures that are designed to protect employees from the un-expected start-up of machinery or equipment.
 
Learning Objectives:

• Recognize the need for Lockout / Tagout.
• Training Requirements.
• Site Specific written procedures.
• Auditing requirements.

Areas Covered in the Seminar:

• Why you should care about Lockout / Tagout.
• Program development.
• Types of energy sources.
• How do you control hazardous energy?.
• Periodic inspections.
• What OSHA expects, and training requirements.

Who Will Benefit:

• Managers
• Supervisors
• All persons responsible for lockout/tagout compliance

 
Note : Use this promocode(111087) to get 10% Discount,Valid till Dec 20th.
 
 
 

 Learn about different statistical sampling strategies and the risk management strategies while auditing.
 
Areas Covered in the seminar:

• Common sampling strategies.
• Risk based selection of sample size.
• Binomial distribution.
• Poisson distribution.
• Confidence intervals around estimates.
• How to justify a sampling plan.
• When is auditing not necessary.

Who will benefit: 
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• QA managers and personnel
• Consultants
• Quality system auditors

 
Note : Use this promocode(111087) to get 10% Discount,Valid till Dec 20th.
 
 
 

 In this Riskability Integration training understand how to integrate Strategy and HR in EGRCM and get acquainted with the procedures that leverage impact of good governance and compliance mandates for adding value.
Areas Covered in the Seminar:

• The development of Corporate Governance as the first mandate for Risk Management.
• Specific mechanisms by which corporate governance impacts the various types of economic crime such as; accounting fraud, insider trading and self-dealing, affecting business operation.
• Detection of crimes like money laundering, bribery, corruption, tax fraud and terrorist financing.
• Corporate culture of ethics and compliance like whistle blowing.
• The functions of EGRCM, internal controls and audit.
• Transparency of information flows to the board and stakeholders.
• A properly functioning audit committee.

Who Will Benefit:

• Governance, Risk, Compliance (GRC) staff
• CFO, Treasurers
• Chief Risk Officers,Chief Legal Counsel,Chief Compliance Officer
• VPs of Risk Management, VP of Finance, Controllers
• Director, Internal audit
• Director, Operational Risk
• Manager, Enterprise Risk Management
• Risk analysts
• IT governance directors/managers
• IT risk directors/managers
• IT compliance directors/managers
• IT Audit directors/managers

 
Note : Use this promocode(111087) to get 10% Discount,Valid till Dec 20th.
 
 
 

 In this Incoterms® 2010 training understand the major revisions of Incoterms, definitions and responsibilities for insurance and the advantages and disadvantages of each term and the cost associated with it.
 
Areas Covered in the Seminar:

• New major revisions to Incoterms.
• Definition of the 11 Incoterms.
• Review of the different groups of terms.
• Transfer of Risk from the Seller to the Buyer.
• Responsibility for Insurance.
• Costs Associated with Each Term.
• Advantages and disadvantages of each term.

Who Will Benefit:

• Exporters
• Importers
• Sales and Marketing Managers
• Purchasing Managers
• Forwarders
• Customs Brokers
• Carriers
• Credit Professionals
• Insurers
• Trade Consultants
• International Bankers
• Attorneys and Legal Staff

 
Note : Use this promocode(111087) to get 10% Discount,Valid till Dec 20th.
 
 
 

 This import compliance webinar will discuss how to create and maintain an import compliance program.
Areas Covered in the Seminar:

• Overview of the Customs Regulations.
• Basic Import Operations
• Broker Management & how to partner with your broker.
• Introduction to Classification.
• Trade Preference Programs, NAFTA, IFTA, GSP.
• Special Duty Provisions U.S. Goods Returned (9801), Goods Returned for Repair (9802).
• Basic valuation.
• Country of Origin and Marking.
• Mandatory Recordkeeping.
• Import Compliance Risk Management.
• How to avoid enforcement action and CBP Focus Assessment or Quick Response Audit.

Who Will Benefit:

• Importers
• Sales and Marketing Managers
• Purchasing Managers
• Forwarders
• Customs Brokers
• Carriers
• Controllers
• Risk Management
• Trade Consultants
• Attorneys and Legal Staff
• Tax Manager
• Logistic Managers
• Supply Chain Managers

 
Note : Use this promocode(111087) to get 10% Discount,Valid till Dec 20th.