Capturing Justifications in Change Control-Risk Assessment or Validation

Tuesday, May 23, 2017 at 10:00AM - 1:00PM
Fremont, CA
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Live Session
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$250.00 $8.62 20

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$500.00 $16.34 23

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$625.00 $20.20 30

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$1,250.00 $39.52 12

Event Details

Description
In this webinar, you will learn about analyses which are regarded as compliant and convenient ways to justify and confirm projects such as Change Controls, Risk Assessments, Validations and Investigations.

When there is a need to make some change to an environment and/or resolve a problem, we must think about a project that could implement the necessary change and address the problem. But we can’t just run our project without proper justification. Justifying the project is a great mechanism to confirm that our project really addresses the need and paves the way for improvement. It helps us assure interested parties or stakeholders that the project implements a particular solution to the problem and explains why this solution is best, as compared to other alternative solutions. But how do we do a project justification? Attend this webinar to learn more.

Objectives of the Presentation
  • Plan an investigation, change control, risk assessment or validation relevant to the area of study
  • Undertake the planned investigation, change control, risk assessment or validation using appropriate scientific principles
  • Collect, collate and analyze the results from the investigation, change control, risk assessment or validation
  • Draw conclusions from the investigation, change control, risk assessment or validation
Why should you Attend
As regulations change and become more stringent, one aspect of compliance has not changed, and that is ensuring changes, deviations, validations and risk assessments are done properly and have a proper justification and rationale. It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result.

In this webinar, you will learn efficient and complaint ways to justify the validations, changes or deviations in a manner that will explicitly demonstrate to the reader why the process was performed the way it was.

Areas Covered
  • How to propose a solution to the problem related to the deviation, change control, risk assessment or validation study
  • Determine alternatives or options to the proposed solution
  • Analyze costs, benefits, impacts, and risks of the proposed solution
  • Validate the solution, assess product impact to the market
  • Determine impact to the patient, system or firm as a result of your findings
Who will Benefit
  • Quality Assurance
  • Quality Control Directors
  • Managers, and Specialists
  • Regulatory Affairs
  • Regulatory Compliance Directors
  • Managers, and Specialists
  • Engineering/Development Directors, Managers, and Specialists
  • Industry & Pharma, Med Device, Biologics.


For Registration
http://www.onlinecompliancepanel.com/webinar/CAPTURING-JUSTIFICATIONS-501953/FEBRUARY-2017-ES-EZEVENT

Note: Use Promo code HJQDZ and get 10% off on registration (Valid till FEBRUARY 28th 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.

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Venue Map (from Google Maps)

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

Starts May 23, 2017 at 10:00AM - 1:00PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896