Solving Statistical Mysteries - What Does the FDA Want?-Online Webinar

Tuesday, May 09, 2017 at 11:30AM - 2:30PM
Fremont, CA

Event Details

This webinar provides an overview of what it appears the FDA is looking for in the use statistics by taking illustrative examples from warning letters and industry experiences and approaches that have worked in a variety of situations.Use of statistics has been part of the FDA's guidance and regulations for many years. Use of statistical tools is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many.

Objectives Of The Presentation
  • Awareness and understanding of what the FDA is looking for in the use statistics
  • Awareness of mistakes pharma and biotech companies frequently make
  • Most used statistical tools: Control charts, capability and performance indices, design of experiments, graphical methods, etc
  • Understanding of what works and doesn't work
  • Obtain information and ideas on approaches that have worked in a variety of situations
  • Problems to be on the lookout for and useful solutions
  • What are the most useful graphical and data visualization methods
Why Should you Attend
To have a complete understanding of what the FDA is requiring pharma and biotech companies to do regarding the use of statistical thinking and methods, and what statistical concepts, methods and tools can be used to satisfy the FDA requirements.

Areas Covered
Today's Reality: FDA Guidance Regarding:
  • Quality by Design
  • Continued Process Verification
  • Test Method Development
  • FDA Guidance's - Examples of Recommended use of Statistical Thinking and Methods
  • Tools, Methods and Personnel
  • What is the Appropriate Documentation?
  • What's the FDA Looking for?
  • Right Process Measurement, Data, Tools and Methods and Interpretation
  • Useful Standards
  • Understanding of tool usage and interpretation of results
  • Tips, Traps and Recommendations
Who will Benefit
  • Executives and Managers of Pharma and Biotech Companies
  • Process and Manufacturing Engineers
  • Quality Assurance Personnel
  • Regulatory Affairs Professionals
  • Quality Control Lab Personnel
  • Quality Engineers
  • Research and Development Scientists
  • Biologists and Microbiologists & Chemists and Chemical Engineers.

For Registration


Note: Use Promo code WE3PL and get 10% off on registration (Valid till MAY 31st 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont, CA 94536

Starts May 09, 2017 at 11:30AM - 2:30PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896