2014 - Webinar On The FDA Medical Device Approval Process: Preparation of 510(k)s, IDEs, PMAs

This web presentation presents an overview of the requirement to obtain FDA permission to market a Medical Device products.
We will discuss the regulatory requirements and the various FDA submissions, the 4 types of 510(k)s and the contents of each. We will also discuss the contents and requirements for IDEs and PMAs, guidelines for each aspect of research are provided, as well as information on the structuring of submissions and post-approval documents. Attendees will get a better understanding of the FDA Medical Device Approval Process and the underlying scientific and regulatory principles involved. The course enables regulatory affairs professionals to provide the FDA with necessary information and obtain product approval.
Areas Covered in the Session :
Navigate the FDA medical device approval system
Preparing contents of the 4 types of 510(k)s
Preparing contents of an IDE
Preparing contents of a PMA
Non-significant risk devices
Significant risk devices
Who Will Benefit:
Regulatory Affairs Personnel
Quality Personnel
Clinical Personnel
Research Personnel
Manufacturing Personnel
Auditors
Legal Personnel
Personnel who require an understanding of the FDA Medical Device Approval Process
Speaker Profile
Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements.
He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP). In addition to training FDA personnel Mr. Ghignone also consults/trains for Drug, Biologic and Medical Device companies, US Army HIV Research Group, NIH AIDS Group, US Army Surgical Research Group and the Naval Medical Research Group. He is a member of the Regulatory Affairs Professionals Society which elected him the 1984 Professional of the Year. He has served the society as Vice President, President and Chairman of the Board of Directors.
In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. In addition he has been involved in two of the largest clinical trials conducted, the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.
Contact us:
5939 Candlebrook Ct,
Mississauga, ON L5V 2V6,
Canada
Customer Support :
416-915-4458
Email :
support-AT-compliancetrainings.com