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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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FDA Medical Device Changes and the 510(k)

FDB3561

Faculty: John E. Lincoln

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Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach

This training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation. The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do. Areas Covered in the Session : Understand what a supplier and vendor audit is Understand the background and basics of supplier and vendor auditing Understand proper auditor conduct Communication Dress Punctuality Difficult situations Learn the necessary skills for conducting audits Understand how to prepare and plan for a supplier and vendor audit Understand and know how to properly perform an audit Opening meeting Touring the facility Questions Observations Close out meeting Learn proper questioning techniques Understand proper audit observation classification Learn to write an audit report Understand conducting a follow up audit Learn how to become lead auditor certified ASQ Certification ISO Certification Who Should Attend: Senior Quality Managers Quality Professionals Regulatory Professionals Compliance Professionals Production Supervisors Validation Engineers Manufacturing Engineers Production Engineers Design Engineers Process Owners Quality Engineers Quality Auditors Document Control Specialists