Developing and Selecting Methods for Evaluating Product Characteristics

Wednesday, May 10, 2017 at 11:30AM - 2:30PM
Fremont, CA

Event Details

The goal of this presentation is to provide information on what is expected for stability studies at different program stages. This will include discussions of what items are required vs. nice to have at each stage, as well as discussing how best to develop and select methods for use in evaluating product characteristics during real time and accelerated storage.

Objectives Of The Presentation
  • Developing phase appropriate methods
  • Applying forced degradation to confirm stability indicating nature of methods
  • Fit for use and assay qualification studies - when are they necessary and how is the data applied?
  • Stability study design and execution
  • When/how should extended characterization methods be applied to stability studies?
  • Evaluation of stability data
Why Should you Attend
  • To gain a better understanding of assay development practices, especially as they relate to stability studies
  • To understand agency expectations for stability programs at different clinical stages
Areas Covered
  • Assay development
    • General principles
    • Forced degradation studies
  • Assay qualification study design and execution
    • What is a complete study?
    • What are the GMP requirements?
  • Stability study design and execution
    • What timepoints and which assays at each timepoint
    • Implementation of extended characterization methods into stability studies
    • Evaluation of stability data
Who will Benefit
  • Stability program leads
  • Analytical development scientists
  • Regulatory / CMC leads
  • Quality control managers
  • Stability coordinators
  • Laboratory directors
  • Stability department personnel
  • R&D laboratory personnel
  • R&D laboratory supervisors and management
  • QC laboratory personnel and management
  • Protein formulation group personnel and management
  • Regulatory affairs personnel & Regulatory affairs management.

For Registration


Note: Use Promo code PTY2D and get 10% off on registration (Valid till MARCH 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 10, 2017 at 11:30AM - 2:30PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896