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Start: 08/10/2010 10:00 am
End: 08/10/2010 11:30 am
This FDA Compliance training will discussion on major changes in FDA enforcement and how the regulated industry should respond to any FDA inspection activity.
Why Should You Attend:
In the first major changes in FDA enforcement in 20 years the US FDA has increased its level of regulatory oversight of regulated industries.From a new Commissioner to additional inspection and pre-market resources the FDA is increasing oversight. While FDA insists that it continues to support innovation in medical products, its primary publicity is in enforcement with an active program to improve its image through increased publicity of enforcement activities and public information on recalls and product risks.
Areas Covered in the Seminar :
- Pressures on FDA.
- FDA Re-organization.
- FDA changes in focus.
- New Enforcement Resources.
- What industry should expect of FDA.
- FDA expectations for responses to FDA-483 observations.
- FDA expectations for responses to Warning Letters.
Note: Use this Promo Code(102040) to avail Discount of 10% on LIVE Purchase.
Start: 08/10/2010 10:00 am
End: 08/10/2010 10:00 am
In this GCP Webinar training, learn how to proactively predict and manage Protocol Deviation/Violation/Exception. Understand the guidance for implementation of “Protocol Not Followed” (PNF).
Why Should You Attend:
As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of “Protocol Not Followed” (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of “Protocol Not Followed” (PNF) are not addressed in the CFR or other regulatory rules. The various terms used to describe PNF (violation, deviation, and exception) are open to different interpretations by the parties involved.
Areas Covered in the Seminar:
- How to define and manage Protocol Deviation/Violation/Exception.
- Proactive approaches to predict and prevent clinical trial protocol violations.
- Industry and FDA perspectives on Protocol Deviation/Violation/Exception.
- Discuss the current lack of unified definition for protocol deviation/violation/ exception.
- Define the term “Protocol Not Followed” (PNF).
- Explain the guidelines for the implementation of PNF to include capturing, reporting, and documentation.
- Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs.
Start: 08/10/2010 11:00 am
End: 08/10/2010 12:00 pm
In this webinar you get to learn what APM is all about and focus on what best practices can be adopted to determine the next stage for the legacy application and the data it has. The session would also delve into the details of retiring or decommissioning the legacy applications and maintain the data from compliance and eDiscovery point of view.
If you are interested do register. Webinar is scheduled on Tuesday, Aug 10, 11:00 am - 12:00 pm (PST).
Start: 08/10/2010 7:12 pm
Join us for this live video webinar on how to grow your business by using video. Social media expert and founder of Help A Reporter Out (HARO) Peter Shankman will share his secrets on how to:
- tell your story in a compelling way on video
- leverage social media videos to get
the word out
- get press attention for your video
We'll be showing plenty of examples and also be giving two selected business videos a 'video makeover'.
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Start: 08/11/2010 10:00 am
End: 08/11/2010 11:30 am
Understanding of Laboratory control system as mentioned in System Based Inspection Guidances and how to use Laboratory control system to evaluate your laboratory.
Why Should You Attend:
Recent FDA 483 Inspection Reports and Warning Letters include many observations that demonstrate that there is a focus on compliance in the laboratory. FDA Investigators evaluate compliance to the CGMPs based on inspectional guidance outlined in two Compliance Policy Guides that provide the basis for system based inspections. One of the six systems defined in these inspectional guidances is the Laboratory Control System. The Laboratory Control System, as defined in these guidances establish the current FDA interpretation of programs that should be in place.
In this webinar we will discuss the Laboratory Control System, as identified in the System Based Inspection guidances. Discussion will be based on the five components of any system: Men, Materials, Machines, Methods, and Measurements, and how the inspectional guidance relates to each of these components.
Areas Covered in the Seminar:
- Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other).
- US- 21CFR211.160 , CPGM 7356.002 , CPGM 7345.848.
- Why the FDA uses a Systems approach to inspections.
- The six systems.
- The Laboratory Control System.
- Procedures, Records and Practices – The basics for all programs.
- Laboratory Control System Components.
- Using the Laboratory Control System to evaluate your laboratory.
Note: Use this Promo Code(102134) to avail Discount of 10% on LIVE Purchase.
Start: 08/11/2010 11:00 am
Generate Revenue with Webinars
~Discover a New Way to Earn Profit
Whether you are looking to earn non-dues revenue or create an additional income source, offering paid webinars is an easy way to profit from your knowledge. This webinar explores ways to best convert your valuable, industry-specific knowledge into something tangible – and profit from it.
What You Will Learn:
• Various types of revenue generating webinars
• Tips to create value from content
• Marketing techniques to attract audiences
• Components required to offer CEU credits
Who Should Attend:
• Professionals who wish to leverage their industry knowledge for profit
• Association Executives who are looking to earn non-dues revenue
• Anyone who has access to content that is valuable to others
All Attendees will receive: a copy of "Costs of Putting Together a Webinar”
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.
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Start: 08/12/2010 9:00 am
End: 08/12/2010 10:30 am
Detailed review the QSR and ISO requirements for supplier evaluation and assessment, and cost efficient options to many of the common practices.
Description:
Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this.Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in complliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.
Areas Covered in the Seminar :
- QSR and ISO 13485 requirements for supplier selection and assessment
- How to qualify new suppliers in a cost efficient manner
- How to assess current suppliers in a cost efficient manner
- How to perform supplier-related corrective action
- Minimum documentation requirements for supplier qualification, assessment, and related corrective action
Note: Use this Promo Code(102165) to avail Discount of 10% on LIVE Purchase.
Start: 08/12/2010 10:00 am
End: 08/12/2010 11:30 am
This EO sterilization training Webinar will discuss how to modify EO sterilization process for complicated medical products which are sensitive to moisture, temperature, vacuum changes.
Why Should You Attend:
Medical products have become more complicated with many containing computer chips, batteries, antibiotics, or other items/materials that make sterilization a significant challenge. These products that present difficult challenges to the EO sterilization process may include those products that have sensitivity to temperature, have moisture limitations, are sensitive to vacuum changes (either level or rate), retain EO, have batteries, or a combination of these factors. Developing a sterilization process presents a challenge but in virtually all cases a process can be developed that meets the requirement to have a sterile functional product.
Areas Covered in the Seminar :
- How to limit moisture exposure.
- Running a low temperature process.
- How to address vacuum sensitivity.
- Parameter inter-relationships.
- How to reduce EO residuals.
- Testing outside of the sterilization facility.
- Considerations for validation and routine processing.
Note: Use this Promo Code(102165) to avail Discount of 10% on LIVE Purchase.
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