Implementing a Change Control Quality System Successfully-OnlineWebinar

Friday, Apr 21, 2017 at 11:30AM - 2:30PM
Fremont, CA

Event Details

This web training session is designed to help attendees understand the fundamental change control steps and processes. The expert trainer will focus on change proposals, assessments, execution and final implementation of a change control quality system. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.

Objectives Of The Presentation
  • Identify what constitutes a change
  • Learn how to properly categorize a change
  • Demonstrate how to write/execute a Change control proposal, assessment and close out
  • Discuss the establishment of a change control board
Why Should you Attend
Change Control is a critical element of the Quality Management System. Changes to processes, equipment, facilities, materials/components, suppliers, test methods, specifications, etc; must be properly managed to prevent unintended consequences, and to comply with regulatory requirements. Improper change control can result in significant compliance and product quality problems.

During this course, the speaker will explain the regulatory basis for change controls, the steps in designing a change control system, and the types of documents or processes that are subject to change control. After completion of this course, you will be able to implement immediate steps in executing a change control form.

Areas Covered
  • Overview of Change Control Regulatory Requirements
    • What is Change Control? / Why Change Control?
    • Types of Changes Subject to Change Control
    • Like for Like
    • Specification changes
    • Facility Changes
    • Equipment Changes
    • Emergency Changes
  • Change Control Proposal
  • Proper documentation
  • Elements to be included
  • Change Assessment (Risk, Impact) and Approval to Execute
    • Impact to products
    • Impact to facility
    • Impact to Regulatory Filings
    • Change Control Board Development
    • Areas of Responsibilities for Board Members
    • Establishing Action Items
    • Establishing Deadlines
    • Final Implementation of Change
      • How to close out a change
    • Effectiveness of the change
    • Change Control Documentation
      • Hard copy systems
      • Electronic systems
Who will Benefit
  • Pharmaceutical professionals involved in the manufacture of products
  • All levels of management
  • Quality professionals
  • Compliance Officials
  • Quality Assurance Personnel
  • Regulatory Affairs
  • R&D and Engineering Staff
  • Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)
  • Supply Chain Managers
For Registration

Note: Use Promo code DE5YU and get 10% off on registration (Valid till APRIL 30th 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 April 21, 2017 at 11:30AM - 2:30PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896