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Successful Change Control Management

 

This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.

$350 
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Areas Covered in the Session :

  • 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 Should Attend:

  • Quality Assurance Teams
  • Quality Control Teams
  • Manufacturing Teams
  • Production Teams
  • Regulatory Teams
  • Management Teams
recording single
for 1 attendees only
recor corp
upto 10 attendees

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Measurement, Analysis, and Improvement for safe and Effective Medical Devices

This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness. This webinar includes strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This webinar will get you started in setting up just such a Quality System. We’ll discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS. In this webinar, we will discuss: – Regulatory Expectations – Common problems and lessons from 483 and warning letters – Red-flags that your QS is not effective – Measurement and metrics – Feedback, Complaint Handling, Internal Audit – Analysis of data – Risk based thinking – Improvement and your CAPA process – Management Review Why You Should Attend: This webinar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You’ll learn to recognize sources of ineffectiveness and inefficiency in your QMS. This webinar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters! The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years’ experience in medical devices. Learning Objectives: Quality System Expectations Characteristics of an effective QMS Characteristics of an efficient QMS Roles, responsibilities, capabilities Red Flags and warning signs Improvement tools and techniques Inspection preparedness and management Best Practices Areas Covered in the Session : Establishing P&PC Change Control Environmental Control Personnel Requirements Contamination Control Buildings Equipment Manufacturing Material Automated Processes Inspection, Measuring, and Test Equipment Process Validation Linkages to the total product life cycle and risk management Process Improvement Who Should Attend: Quality Systems Specialists Document Control Specialists Quality and Compliance Specialists Auditors Auditor Managers Compliance Managers Quality Managers CAPA Specialists Quality and Compliance directors for Medical Device companies General Managers and Executives wanting to use Compliance and Quality as a competitive strength

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ISO 14971:2019 Medical Device Hazards and Risk Management – All you need to know

Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while increasing user benefits. What “risk” is to be analyzed? One of the best tools to achieve and document this is ISO 14971 for devices. Recently ISO 14971 was changed. The 2019 version is replacing the 2014. What does that mean for medical device designers, specification developers, manufacturers, QA and RA? How should the change be managed? Common considerations: Many cGMP activities must be “Risk-Based”. What does that mean; what does it not mean? – An important distinction, which, when neglected, has resulted in several Warning Letters from the US FDA. How does ISO 14971 address risk-based. How is it mandated to be used in software verification and validation. How does it impact CAPA / NCMR / Complaint investigations. Many firms use some product risk management tools, but are not compliant to ISO 14971 in any version, for devices. What changes would be necessary to become compliant? What are Europe and U.S. regulatory expectations? What benefits beside regulatory compliance can be achieved for a company? Why You Should Attend: In this important webinar, see the elements recommended or expected to be in the Risk Management File / Report. Learn how to blend ISO 14971 into a company’s cGMP system, which is a requirement of regulatory agencies. What should be the areas of focus. Make the document a “living” document. Achieve major business benefits by regular use of the Risk Management File / Report in training, marketing, validation, root cause analysis, CAPA activities and failure investigations, as well as the obvious, increased product safety and reduced liability. Areas Covered in the Session : The Changes; Timelines Key Requirements of ISO 14971 Suggested formats Expected sources of information to evaluate What to include How to complete, document, and control Areas of contraversy An often neglected safety feature A “living” useful, cost-saving document Is it being used to its full business benefit? Who Should Attend: Quality Assurance Departments Research and Development Departments Regulatory Affairs Departments Manufacturing Departments Engineering Departments Operations Departments Production Departments Validation Departments Documentation Departments Consultants

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Achieving Compliance with Proper CAPA Systems

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