This validation training will discuss FDA impacts and approaches for compliance for use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing.
Areas Covered in the Seminar:

• Tougher FDA and EU MDD Software V&V Expectations.
• Key COTS Software Apps V&V Requirements .
• Problem Areas.
• Product, Equipment/Process, QMS and Apps Software and Part 11 Requirements .
• Realistic Limits of Apps Software V&V .
• Suggested Approaches.
• How to Implement, Execute and Document.
• Proper Risk Allocation of Scarce Resources.

Who Will Benefit:
This webinar will provide valuable assistance to personnel in all regulated companies responsible for software validation under the cGMPs and EU MDD/CE-marking. This information applies to personnel / companies in the FDA-regulated industries, e.g., Devices, Pharmaceutical, Diagnostic, Biologics and Dietary Supplements. The employees who will benefit include:

• Senior management
• Regulatory affairs
• Quality Assurance / QAE
• Production
• Software Implementers
• Engineering
• Sales and Marketing
• All personnel involved in a U.S. FDA- and/or EU ISO 13485/MDD -regulated environment

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In this Laboratory Investigation training learn what constitutes an OOS observation, what are the guidance's process & Steps to be taken in the laboratory in the event of an OOS observation.
Why Should You Attend:
Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic, OOS procedures and investigations are still a topic of FDA Investigator review and findings. An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion.
There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this webinar we will discuss the investigation that goes on within the laboratory. Although the focus will be on the FDA Guidance, the discussion will include suggestions for a process that will meet the FDA expectations.
Areas Covered in the Seminar:

• Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other).
• US.
  • 21CFR211.160
  • FDA Guidance to the Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
• ICH.
  • Q7; 11.1
• Canada.
  • C.02.015

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 Why Should You Attend: 
 
Health related quality of life (HRQOL) research is designed to measure patients’ input into the effects of disease and/or treatment and possibly to distinguish between treatments or devices; however it is fundamentally different than traditional medical assessments. HRQOL is not efficacy or safety, yet it can provide an alternative and valuable medical insight.
This webinar presents an introduction to HRQOL that will crystallize knowledge of underlying concepts, strategies, and processes; it will facilitate the attendees’ ability to be conversant, to assist in planning studies, and to avoid common mistakes. Additionally, it is designed to allow for accurate interpretation of HRQOL results and increase the probability of research success. Also, the FDA regulatory implications for PROs will be discussed.
Areas Covered in the Seminar:

• Defining health-related quality of life (HRQOL).
• FDA Guidance.
• Labeling/Package Insert Issues: US and EU.
• Why do HRQOL research?.
• Generic vs disease-specific instruments.
• Examples of questions and questionnaires.
• Scoring questionnaires.
• Psychometric properties - reliability/reproducibility, validity, and responsiveness.
• When to do HRQOL in the drug development process.
• Monitoring issues.
• Statistical issues.
• Proper placement in the protocol and study report.
• References/Bibliography.

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Learn FDA requirements for 21 CFR Part 11, understand how to implement with the help of SOPs and case studies.
Why Should You Attend:
Though FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just in 2007/2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. Also FDA's computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies. This seminar will give a good understanding of current and future FDA requirements for 21 CFR Part 11 and provide steps, examples and tools for cost-effective implementation. Attendees will receive SOP to define and document scope and control of part 11. Along with it 15 case studies containing step by step description and recommendation for part 11 requirements.
Areas Covered in the Seminar :

• FDA's current inspection and enforcement practices.
• FDA's current interpretation: learning from FDA guidance, and FDA conference presentations and discussions.
• Learning from FDA inspection reports.
• Part 11 and the new EU Annex 11: similarity and differences.
• Strategy for cost-effective implementation of the 'new' Part 11:A six step plan.
• Recommended changes to existing Part 11 programs to reduce costs.
• Justification and documentation for the FDA and your management.
• Going through case studies from laboratories, offices and manufacturing.
• Preparing for Part 11 Inspections.