Process Validation for Medical Device Compliance - Online Webinar

Wednesday, May 24, 2017 at 9:30AM - 12:30PM
Fremont, CA

Event Details

The FDA finds inadequacies in process validation with Medical Device firms frequently. In fact, the fourth most frequently-cited Form 483 observation for medical device firms is for Process Validation. Find out how you can avoid these observations and emerge from your FDA audit with zero observations! Medical device validation can be confusing, but this webinar will clear many of the misconceptions related to process validation for medical device companies and helps you to bring your validation program to ship-shape!

Objectives Of The Presentation
  • The attendee will receive an overview of validation, the key elements (DQ/URS, IQ/OQ/PQ and PV) and understand how these validation elements relate to one another
  • The attendee will relate the requirements of process validation back to specified parts of Code of Federal Regulations, to assure compliance with the law
  • The attendee will learn the medical device validation guidance requirements and the apparent discrepancy with pharmaceutical validation
  • The attendee will be able to distinguish Validation from Verification
  • The attendee will understand key differences between the major elements of medical device validation and pharmaceutical validation practices
  • The attendee will learn how to maintain a continual validation state for devices and compare/contrast continual validation with the pharmaceutical notion of continuous process verification
  • The attendee will understand other validation elements that support Process Validation to contribute to an overall comprehensive medical device validation program
Why Should you Attend
The requirements for process validation for medical devices can be confusing, because the correspondence between medical device validation and pharmaceutical validation actions seem to contradict with one another. This webinar will point out the similarities and differences to put your process validation in ship-shape, so you can pass a validation audit for a medical device manufacturing facility.

Areas Covered
  • IQ/OQ/PQ
  • Process Validation
  • Characterization vs. Engineering Studies vs. OQ
  • Difference between GHTF guidance and ASTM E2500 approaches to process validation
  • The importance of sound statistical techniques
  • Leveraging pharmaceutical guidance to demonstrate that your process maintains a validated state
  • Other validation topics
Who will Benefit
  • Engineers
  • R&D personnel
  • Quality Assurance personnel (Technicians, Managers, Directors)
  • Statisticians
  • Manufacturing Engineers
  • Process Engineers
  • Quality Managers
  • Quality Engineers
  • Regulatory Professionals
  • Production Managers
  • Risk Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners
For Registration

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 24, 2017 at 9:30AM - 12:30PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896