Webinar On Annual Reports for Approved PMAs

Compliance Trainings, Online
2014-11-07

This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for level of detail the applicant should provide in the PMA annual report. Also addressed are the steps FDA staff generally takes when reviewing annual reports and the actions FDA may recommend after the annual report review. Also covered in this webinar are other reports – post-approval study reports.

A must attend webinar for those personnel that require an understanding of the FDA’s requirements for PMA annual reports.

Areas Covered in the Session :

Contents of a PMA Annual Report

Detail Required in an PMA Annual Report

FDA Review of PMA Annual Reports

Actions FDA May Recommend After PMA Annual Report Review

Post-Approval Study Reports

Interactive Q&A Session

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Laboratory Personnel

Manufacturing Personnel

Legal Personnel

Clinical Research Associates

Personnel who require a general understanding of the FDA’s Requirements for PMA Annual Reports

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1402

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

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