GlobalCompliancePanel, 1300 Veterans Blvd. - South San Francisco, California 94080 USA
2014-10-30
Summary of the workshop: This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved. Participants will learn what a Combination Product is, learn about mode of action and primary mode of action, how to prepare a Request for Designation submission, Combination Product user fees, GMP for Combination Products and how to interact with the FDA Office of Combination products. They will also learn about submissions for post-approval modifications for a Combination product. This course provides the participant the ability to understand the entire FDA Combination Product Process and how to navigate through the FDA Combination Product Process to get your Combination Product onto the US marketplace. Learning Objectives from this Workshop: Learn about the FDA Office of Combination products Learn what a Combination Product is Learn the FDA Combination Product Process How to navigate the FDA Combination Product system Mode of action and primary mode of action How to prepare a Request for Designation User Fees for Combination products GMPs for Combination products Post-Approval Modifications Meet your Expert: 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. RAC Credits: 12 Date: October 30th & 31st, 2014 Event Details: http://bit.ly/CombinationProducts Location: San Francisco, CA Venue: Courtyard San Francisco Airport/Oyster Point Waterfront Venue Address: 1300 Veterans Blvd. - South San Francisco, California 94080 USA Venue Link: http://www.marriott.com/hotels/travel/sfoop-courtyard-san-francisco-airport-oyster-point-waterfront/ Registration: Open Enrolment Price: $1295.00 Delivery: Face-to-Face event Until September 26, Early Bird Price: $1,295.00 From September 27 to October 28, Regular Price: $1,495.00 Audience: Regulatory Affairs Personnel, Research Personnel, Quality Personnel, Clinical Personnel, Manufacturing Personnel, Personnel who require an understanding of the FDA Combination Product Process. Course Web Site: https://www.globalcompliancepanel.com/control/~product_id=900080SEMINAR/combination_products_US_marketplace Organizer:
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management.
Our Achievements: Over 300 Experts that are Renowned in their Respective Areas Successfully Trained more than 20,000 Compliance Professionals A Most Comprehensive Portal for Trainings, Industry Updates and Professional Growth Having more than 2000 Online Courses Successfully Completed more than 170 Seminars in US and Globally Provider: GlobalCompliancePanel John Robinson 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: www.globalcompliancepanel.com
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