Areas Covered in the Webinar:
Concept of quality management system
All clauses in ISO 13485
Auditable clauses of ISO 13485
All parts of the FDA’s QSR
Who is responsible for complying with QSR
Differences between ISO 13485 and QSR
Role of management in quality
Exclusions from specific parts of the regulation or standard
Internal audit requirement
Who Will Benefit:
Medical device manufacturers
R&D teams for medical devices
Personnel involved in the packaging of medical devices and packaging engineers
Inventory control personnel in a medical device company
Quality personnel and quality engineers
Suppliers to medical device companies
Areas Covered in the Webinar:
Verification & validation types.
Consequences of poor verification & validation.
Why verification & validation makes good business sense?
To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle
To demonstrate the requirements of ISO 14971, how they reflect FDA concerns
To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements
To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers
To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012
To provide attendees with the Dos and Don'ts for an effective and efficient risk management system.
The FDA inspection is one of the critical measures of your quality system and your organization as a whole. Since a perfect quality system is usually not implemented, the preparation for and management of an FDA inspection is critically important. A well-established quality system provides a solid foundation for passing FDA inspections; however, if you don’t proactively examine your quality system from the perspective of a FDA inspector, you can still have difficulties.
Use coupon code 232082 and get 10% off on registration.
You will be able to answer the following questions with this course without saying, “I don’t know?”
What are the FDA’s import legal requirements and policy?
How do you deal with the FDA and the U.S. Customs and Border Patrol procedures?
What happens when your product is detained?
What happens if a foreign manufacturer is in trouble with the FDA?
How do you inter-act with the FDA to work out problems?
Why are import and export rules different or does it even matter?
Seminar Instructor Casper Uldriks is an "Ex-FDA Official" who has spent 32 years in FDA and his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.
Upon completing this course participants will understand:
Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
When to file for a new device, a change in the intended use or a change in the technology of a cleared device
What is contained in a traditional, abbreviated and special 510(k) submission package
The submission package, user fees and making an eCopy
What is substantial equivalence and what’s required to show substantial equivalence
What’s required on the labeling and IFU
Which performance tests should be conducted and how to present the data to the FDA
The requirements for a risk management plan and report
Understand the FDA’s Refuse to Accept Policy
What is required in a submission for software controlled devices
How and when to use third party reviews
When clinical data may be required.
Understand FDA rules and policies regarding manufacturing and labeling of low risk OTC drugs not covered by approved New Drug Applications.
Learn the definitions of drug, cosmetic, dietary supplement.
Understand how labeling other than labels and advertising can define a product and cause it to be misbranded or considered a new drug.
Differentiate cosmetic “puffery" claims from claims that FDA would likely consider drug claims.
Understand the differences between allopathic (conventional) drugs and homeopathic drugs.
Recognize ways to manufacture low health risk products at minimum cost, yet still meet the intent and basic requirements of GMP regulations.
Learn how to minimize the regulatory risk of a Warning Letter or other FDA action.
This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years’ experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions.
Understand how to comply with complicated Compliant Handling, MDR and Recall requirements.
Firms MDR reporting and FDA's handling of reports.
Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA.
Who will Benefit:
This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.
Use coupon code NB5SQH8N and get 10% off on registration.