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 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.
 
 
 

This GCP training Webinar will discuss the principals of GCP, the regulations pertaining to it and elements necessary for FDA compliance.
Why Should You Attend:
This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining ongoing compliance will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for their clinical studies.
Areas Covered in the Seminar :

• Discuss the FDA's role in Drug Development.
• Principles of GCP.
• Activities that are common to most trials.
• Summarize FDA GCP regulations.
• Recognize how GCP impacts the clinical research process.
• Prepare concise documents and provide.
• Necessary information for clinical studies compliance.
• Maintain ongoing compliance.

In this NDA Approval Process training Webinar learn the guidance and regulations governing FDA's acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials.
Why Should You Attend:
While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such submissions accepted by FDA – mainly in limited therapeutic areas. Given lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, especially generic and 505(b)(2). Due to shortcomings found during site inspections, lack of inspection resources and the general tightening of FDA safety reviews, FDA has started imposing some “unwritten” requirements for the acceptance of such data. This webinar explores these requirements and how you can ensure compliance.
Areas Covered in the Seminar :

• Guidances and regulations that govern the FDA's acceptance of foreign trial data as pivotal data for NDA approval.
• What you can do to ensure compliance.
• Design considerations and requirements for foreign trials.
• Identify which guidances and regulations govern the FDA's acceptance of foreign trial data as pivotal data for NDA approval;.
• Discuss how FDA is implementing these rules and what you can do to assure compliance; and
• Recognize design considerations and requirements for foreign trials.

In this Clinical Trial training learn about clinical trial Vendor Assessment, Project Management, Outsourcing, and Trial Design.
Why Should You Attend:
When it comes to clinical trials, trial Sponsors have now the opportunity to outsource anything from the design phase to medical writing and even submission of marketing applications for the product. It is an undeniable challenge for any sponsor to perform this outsourcing in a cost effective manner, while ensuring that this has been conducted reliably and under compliant circumstances.
Pharmaceutical companies are reducing the internal resources, while conducting more clinical trials than ever before. At the same time, the growing complexity of the design of the trials is becoming critical to the integrity of the trial data as well as the costs relating to its conduct. How would you assure that the right vendor is in charge of your trial? How can you protect your business interests while ensuring the quickest and least costly way to bring your product to the market? As the sponsor what is your responsibility, even if you have outsourced “everything” to your vendor?
Attend this webinar to understand the best practices of vendor pre-assessment, selection and post-assessment including performance assessment and how to manager vendors.
Areas Covered in the Seminar:

• Background of Outsourcing.
• The Current Industry Trends.
• Advantages vs. Weaknesses of Outsourcing.
• Regulatory Expectations.
• Suggested Process For Vendor Pre-assessment & Selection (Incl. Documentation).
• Managing Vendors.
• Performance Assessment for Future Trials (Lessons Learned).
• Identifying & Logging Preferred Vendors.