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GMPs for Medical Devices and Key Medical Device Observations

Duration : 60 Minutes

Charles H. Paul,

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults Read more

On-going training concerning Good Manufacturing Practices is a requirement for all staff involved in the manufacturer of medical devices.  Regulations are complicated, and today more than ever before, because of global regulatory requirements, companies must be familiar with and comply with the regulations governing the products they make, for each country in which they sell. 

This 60-minute overview of GMPs for medical devices will touch upon several topics that are timely and pertinent to the medical device industry.  New regulations, proposed regulations and/or proposed changes to existing regulations will be reviewed and discussed.  This webinar will also review the key medical device observations with an emphasis upon where organizations should focus their regulatory efforts for the coming year.  With the new EU MDR changes coming this year, it is critical to a complete treatment of this subject to overview the impact of this regulation and the changes this new regulation will impose upon EU medical device business.

Course Objective:

• Review Governing Regulations FDA CFR Part 820 – Review of Subparts A through O
• Discuss the relationship between FDA CFR Part 820 to ISO 13485
• Discuss new FDA proposed regulations and rule changes
• Understand the potential impact of key FDA regulatory observations
• Review the new EU Medical Device Regulation
• Review the topic of design controls and understand their importance to medical device regulatory compliance
• Discuss the regulatory implications of mobile applications on the medical device industry
• Discuss the regulatory implications that impact combination products
• List and describe the elements of risk-based compliance and how it is executed across the enterprise
• Explain how to best demonstrate inspection readiness
• Explain the purpose and function of internal audits, and when and how they are performed
• Explain how cGMPs relate to and impact third-party relationships

Course Outline:

• Proposed/new regulations and rule changes
• Hot Topics – key regulatory observations
• Importance of design controls
• Mobile applications
• Combination Products
• Governing Regulations FDA CFR Part 820 – Review of Subparts A through O
• Relationship of FDA CFR Part 820 to ISO 13485
• EU Medical Device Regulation
• Compliance and Enforcement

What You Get:

• Training Materials
• Live Q&A Session with the Speaker
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

This webinar will be beneficial to anyone involved in the manufacturer of medical devices from the production floor through management and quality assurance to regulatory.

• Quality Assurance
• Regulatory Compliance
• Research & Development
• Regulatory Affairs
• Product Development Professionals
• Production Department
• QA/QC analysts
• Quality Control
• Quality Assurance scientists
• Quality Auditors / Internal Auditors
• Consultants
• Quality Unit managers and supervisors
• Manufacturing
• Training Managers and Directors

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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