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« Week of August 1, 2010 »
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Auditing vs. monitoring, defining the purpose, application and process
Start: 08/03/2010 10:00 am
End: 08/03/2010 11:00 am

 Why Should You Attend:
When conducting a clinical trial, the regulatory bodies expect from the sponsor to be in control of the quality of the trial. More specifically the sponsor should monitor (QC) and audit (QA) the trial in order to address this expectation. In addition, monitoring and auditing the trial provides the sponsor with information and insight that perfectly serves the purpose of protecting, as well as improving, the sponsor’s business interests by helping sponsor preventing legal, ethical or financial issues, related to possible error or trial misconduct, proactively from happening.
Areas Covered in the Seminar:

  • Background and Definitions.
  • Roles and Responsibilities.
  • Symbiosis of Monitoring & Auditing.
  • Planning & Conduct of Monitoring & Auditing.
  • Identifying & Handling Possible Fraud And Misconduct.
  • Ensuring A successful Trial Conduct.
  • Continuous Improvement.
  • Past Lessons vs. Future Trials.

 

U.S. FDA cGMP Compliance Audits -- Raising the Bar
Start: 08/03/2010 10:00 am
End: 08/03/2010 11:30 am

This FDA cGMP training webinar will discuss US FDA's approach to cGMP Audits and expectations from companies. It will also evaluate chief concern areas of cGMP compliance audit and anticipatory emphasis changes as per new regulatory climate.
Why Should You Attend :
Recent audits indicate the past ways of doing things will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. Recent headlines indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA. How this is affecting the Agency's approach to audits and their expectations for companies. Pressure on the 510(k) process is only one example. How they drive companies to do much of their work for them. We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate.
Areas Covered in the Seminar :

  • The "target".
  • Avoid complacency from past "good" FDA audits.
  • Avoid complacency from just completed "good" ISO audits.
  • The desired response.
  • How to respond now -- where to shift focus first.
  • Where to direct scarce resources.
  • A risk-based phased approach.
  • Maintain 'the edge'.

Note: Use this Promo Code(101642) to avail Discount of 10% on LIVE Purchase.

4
How Accurate Adverse Event Reporting is the Key to Subject Safety of approved drugs
Start: 08/04/2010 10:00 am
End: 08/04/2010 11:00 am

 In this Clinical compliance training learn how to assess record and manage the adverse events occurring during conduct of clinical research utilizing human subjects and how to avoid the common mistakes.
Why Should You Attend: 
The principal objective in a new drug development program is to assess the benefit / risk ratio. AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge. To obtain 'commonality' in reporting, investigative sites require familiarity with one of the Adverse Event Terminology systems. As codified in 21 CFR 312.64(b), an investigator shall promptly report to the sponsor any adverse event that may reasonably be regarded as caused by, or probably caused by, the drug. Determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment).
 
Areas Covered in the Seminar:

  • The CFR definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more.
  • How to know what an Adverse Event is and when to report it or them.
  • Understanding laboratory AEs and the "Reference Range" concept.
  • Common Mistakes in AE / SAE Reporting.
  • Reporting of Adverse Events - when and to whom and the use of AE Terminology systems
  • The Role of Data safety Monitoring in Protecting Human Volunteers
  • How to record Adverse Events and assess causality - the algorithm

 

5
Food Recalls - Planning and conducting a Food Recall and Crisis Communication
Start: 08/05/2010 10:00 am
End: 08/05/2010 11:00 am

In this Food Recall training learn how to create a crisis response plan, data gathering, investigation phase specifics and how to communicate under different scenarios.
Why Should You Attend :
Reacting is the norm but anticipating and preparing are what's needed. Creating a robust process that will protect both the consumer and the company's reputation requires careful planning and the active involvement of each department. Another crucial element is communication, with the public as well as customers and shareholders. The risk posed by the product is one important element but anticipating the consumer's reaction is key. Whether they respond with disinterest to a serious hazard versus outrage requires a different communication strategy. As well, the messages sent at the outset of the recall will be different than when the regulator gets involved and different again as the recall reaches a conclusion.
The course will describe how to create the most comprehensive Recall Plan (or Crisis Response Plan).Once the process has been documented we will review the Data Gathering / Investigation phase specifically and give examples of microbiological studies (e.g. Listeria monocytogenes) important issues to be remembered. We will discuss what are the best practices of an effective crisis communication. We will discuss the roles and approaches under different crisis scenarios.
Areas Covered in the Seminar :

  • Why should we have a Crisis Response Plan.
  • How to create a flow diagram of the steps in a product recall.
  • Develop list of team members' roles and responsibilities at each step.
  • Understand product recovery vs product recall and its classification.
  • Example of the recent product recall and its trickledown effect.
  • Example of investigation process of a Listeria outbreak.
  • Review the best practice for effective Crisis Communication.
  • Outline the responses / approaches based on a variety of crisis scenarios.
  • Questions and discussion: What do you see your role to be and the others in your company and add suggestions.

Note: Use this Promo Code(101776) to avail Discount of 10% on LIVE Purchase.

Validate COTS Software in one-third the time
Start: 08/05/2010 10:00 am
End: 08/05/2010 11:00 am

Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.
Why Should You Attend:
This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach is detailed so that the specific documents for a validation project are understood. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the cost. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.
Areas Covered in the Seminar :

  • Learn which documents the FDA expects to audit.
  • Proven techniques that reduce software costs and implementation times.
  • Increase corporate productivity and individual workforce member productivity.
  • Efficiently create validation documentation.
  • Decrease resource requirements.
  • Make documentation more manageable and understandable.
  • Avoid 483s and Warning Letters.
  • How to implement a computer system to gain maximum productivity.
  • Use resources effectively to perform effective validation while avoiding doing too much.
  • How to link requirements, specifications, risk management, and testing.
  • Document a computer system validation project using easy to understand fill-in-the-blank templates.
  • Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).
Best Practices in Call Center Scheduling
Start: 08/05/2010 10:00 am
End: 08/05/2010 11:00 am

Monet Software will host a webinar on Thursday, August 5, 2010 at 10 AM PST with the topic “Best Practices in Call Center Scheduling”. The webinar is based on the premise that optimal call center performance starts with an optimal schedule. Industry expert, Chuck Ciarlo who successfully owned and operated multiple call centers, will talk about the following topics:

- Schedule optimization: How to properly handle call, non-call activities and exceptions, breaks, lunches, training, etc.

- Forecasting: How to deal with call volume fluctuations and adjust schedules

- Schedule adherence: How to set goals, measure adherence and keep agents motivated to adhere to schedules.

Those interested in attending this complimentary webinar can register prior to the event at http://www.monetsoftware.com/Why-Monet/Webinars/.

6
How to conduct a software risk assessment that is meaningful
Start: 08/06/2010 10:00 am
End: 08/06/2010 11:00 am

Get detailed understanding of how to perform risk assessment as part of 10 step risk based approach to CSV.
Why Should You Attend:
Learn how to perform risk assessment as part of the 10-step risk-based approach to computer system validation. Minimize project time using fill-in-the-blank templates. Ensure compliance with QA, FDA, and clients. What makes this session unique are the real life examples that make application of the techniques understandable in the context of any validation project.
Areas Covered in the Seminar :

  • How to use the risk-based approach to reduce validation time and lower costs.
  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
  • Reduce testing by writing test cases that trace to elements of risk management.
  • Avoid 483s and Warning Letters.
  • Interactive real life examples.
  • How to identify risk and establish mitigations.
  • Determine risk in a process to reduce the testing effort.

Note: Use this Promo Code(101902) to avail Discount of 10% on LIVE Purchase.

Reducing Ethylene Oxide (EO) Sterilization costs while maintaining regulatory compliance
Start: 08/06/2010 10:00 am
End: 08/06/2010 11:00 am

In this Ethylene Oxide (EO) Sterilization training learn how to evaluate your sterilization process for cost reduction, and will learn how to implement such changes without jeopardizing product safety and regulatory compliance.
Why Should You Attend:
Many medical device manufacturer companies are not taking the advantage of latest sterilization technologies and knowledge to effectively reduce the sterilization process cost. This is due mainly to: lack of knowledge of latest technologies fear of getting out of regulatory compliance believes that changes to the sterilization process are too complex or risky.
The application of vanguard sterilization technologies will allow you to reduce sterilization costs with programs such as : reducing or eliminating preconditioning, reducing or eliminating aeration, BI elimination, EO gas consumption reduction and chamber utilization maximization. In this seminar you will acquire the knowledge to evaluate your sterilization process for cost reduction, and will learn how to implement such changes without jeopardizing product safety and regulatory compliance. Analyzing the microbiological and EO residues aspects of your cycle with a different approach will result in re-engineering it for cost reduction and avoidance while complying with EN/ISO11135.
Areas Covered in the Seminar :

  • Introduction.
  • Factors Influencing Lethality and Aeration.
  • Finding Opportunities for Cycle Optimization.
    • Negotiate cost reduction
    • Initial Validation Evaluation
      • Microbiological Method
      • Cycle Parameters Evaluation
      • EO residues dissipation curves
      • Product Evaluation
  • Cycle/Process Re-engineering
    • BI Incubation reduction
    • Parametric Release
    • PCD/Packaging/Pallet modification
    • Lethality curve development
    • Aeration modification
  • References.

Note: Use this Promo Code(101902) to avail Discount of 10% on LIVE Purchase.

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