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Applying U.S. FDA Laws and Regulations 2017

Start Date:
Thursday, 2 March, 2017
End Date:
Friday, 3 March, 2017 5:00pm
Psychiatry, Rheumatology, Internal Medicine, Emergency Medicine, Pulmonary Medicine, Physical Medicine, Sports Medicine, Headache / Migraine

Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.Overview: This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries.

In these 2 days, the following essential topics will be covered:Total Product Life Cycle and Your Medical DeviceAn Overview of U.S. FDA Medical Device RegulationRegulations for Design and Product DevelopmentPremarket Notification - 510(k) and Premarket Approval (PMA)Regulations for Production & Process ControlReadiness for FDA Facility InspectionWhy should you attend?The complex network of multilayer laws, regulations and regulatory requirements create confusion and misinterpretation that leads the device manufacturer into Non-compliance state.

Non-compliance to applicable laws and regulations results into severe penalties or regulatory actions form U.S. FDA that could damage image and position of the company. To avoid such undesired circumstances, it is important to see a big picture of TPLC and all applicable U.S. FDA laws and regulation at each phase of their own product life cycle.Areas Covered in the Session:An Overview of U.S. FDA Regulation for Medical DevicesQuality System Regulation 21 CFR 820: Current GMP for Medical devicesPremarket Notification - 510(k) and Premarket Approval (PMA)Post Market Reporting RequirementsFDA Facility InspectionWho will benefit:Regulatory Affairs - VP, Director and ManagersRegulatory Affairs - Associates and SpecialistsCompliance OfficersResearch & Development - Product ManagersQuality Assurance and Quality EngineersAgenda:Day 1 Schedule: Lecture 1:Total Product Life Cycle and Your Medical DeviceUnderstand various definitions of Total Product Life CycleImportance for define TPLC for your own medical devicePractice Exercise: Define TPLC of your own medical deviceBuilding Regulatory Strategy considering TPLCLecture 2:An Overview of U.S.

FDA Medical Device Regulation - Part 1Lecture 3:An Overview of U.S. FDA Medical Device Regulation - Part 2Lecture 4:Regulations for Design and Product DevelopmentResearch & DevelopmentDesign Development and ControlPrototype Product DevelopmentDesign VerificationDesign ValidationDesign Transfer to Manufacturing/ProductionHelpful Hints and SuggestionsDay 2 Schedule: Lecture 1:Premarket Notification - 510(k) and Premarket Approval (PMA)Determine Class of your Medical Device for Regulatory ControlsExemption form Premarket and QS Regulation requirementsPremarket Notification - 510(k)Premarket Approval - PMAInvestigational Device Exemption - IDE for clinical studiesPreparation of Premarket SubmissionsHelpful Hints and SuggestionsLecture 2:Regulations for Production & Process Control - Part 1Purchasing & Supplier ControlsDocument ControlDevice Identification and TraceabilityAcceptance & Nonconforming Product ControlLabeling & Packaging ControlHelpful Hints and SuggestionsLecture 3:Regulations for Production & Process Control - Part 2Corrective Action and Preventive Action (CAPA)Records - Device History Record, Device Master Record, QS RecordComplaint Files including Medical device Reporting (MDR)Post Market Reporting ResponsibilitiesHelpful Hints and SuggestionsLecture 4:Readiness for FDA Facility InspectionFDA Authority & PracticesFDA Compliance Program Policy, Strategies and ApproachPrepare and Stay Focused during InspectionResponding to FDA Form 483 ObservationsResponding to Warning LetterPlanning and Managing Remediation Project & ActivitiesAdditional Regulatory ActionsSpeaker: Subhash R PatelSubhash Patel is an accomplished Regulatory Affairs Professional offering 30 plus year of experience in authoring, preparing and submitting more than 150 successful premarket submissions to U.S.

FDA. He brings his expert knowledge and hands-on experience in developing a robust premarket submission that secures clearance or approval from U.S. FDA. He offers valuable tips and suggestions on "what works and what doesn't" form his own experience. He has presented numbers of technical papers at conferences and conducted plentiful training seminars in various countries.He is a Fellow of world's renowned Regulatory Affairs Professional Society (RAPS) and holds professional recognition as a Regulatory Affairs Certified (RAC) form RAPS.

He also holds professional certification as Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) form American Society for Quality (ASQ). His educational background includes BS degree in Mechanical Engineering and BS degree in Chemistry. He founded MD Reg Consulting, LLC based in New Jersey, USA to serve medical device industry clients in all aspects of global regulatory affairs and specific to their needs.

Location: SFO, CA Date: March 2nd & 3rd, 2017 and Time: 08:30 AM to 5:00 PM Venue: DoubleTree by Hilton Hotel San Francisco AirportAddress: 835 Airport Blvd., Burlingame CA 94010-9949 Price: Price: $1,295.00Until January 20, Early Bird Price: $1,295.00 From January 21 to February 28, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Until January 20, Early Bird Price: $1,295.00 from January 21 to February 28, Regular Price: $1,495.00Register now and save $200. (Early Bird) Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email:


DoubleTree by Hilton Hotel San Francisco Airport 835 Airport Blvd.,
Burlingame CA,

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
Event Manager

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