Course "Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA" 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 designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered:
History and background of U.S FDA Laws and Regulations
Classify Your Device
Choose the Correct Premarket Submission for your device
Compile the Appropriate Information for your Premarket Submission
Author and Prepare your Premarket Submission
Submit your Premarket Submission to the FDA
Interact with FDA Staff during Review and Approval
Complete the Establishment Registration and Device Listing
Why should you attend?
The U.S. FDA regulatory 510(k) clearance and Premarket Approval (PMA) process is considered a most stringent and complex. Only a good knowledge of U.S. FDA laws, regulations, and requirements is not sufficient to win a clearance/approval. You are required a proper training on how to set and state regulatory arguments for your device in a most convincing manner to the U.S. FDA reviewer. This 2 days training seminar will walk you through building process of a reader’s friendly but resounding premarket submission and also give you tips and suggestions on how to work effectively with the U.S. FDA officials during review and approval process of your submission.
Areas Covered in the Session:
Food, Drug and Cosmetic Act (FD&C Act)
Title 21 Code of Federal Regulations (CFR) for Medical Devices
Premarket Notification (510k)
Premarket Approval (PMA)
Investigational Exemption Device (IDE)
Points to Consider for preparing a Successful Premarket Submission
Tips and Suggestions on interacting with FDA Officials
Post Market Requirements of Medical Devices
Who Will Benefit:
Marketing Professionals
Research & Development - Product Managers
Quality Assurance and Quality Engineers
Project Managers responsible for United States
Buyers/Purchasing Professionals
Students majoring in Regulatory Affairs
Agenda:
Day 1 Schedule:
Lecture 1:
An overview of U.S. FDA Premarket Regulations
History and background of U.S FDA Laws and Regulations
How to Classify Your Device
Choose the Correct Premarket Submission for your device
Lecture 2:
Premarket Notification 510(k)
Applicable Laws, Regulations and Requirements for 510(k)
Decide Type of 510(k)
Compile the Appropriate Information for 510(k)
Format and Content of your 510(k)
Lecture 3:
Premarket Notification 510(k) - continue
Suggestions on What to Include or Exclude into your 510(k)
Tips on authoring a reader's friendly and convincing 510(k)
Critical Review of your prepared 510(k) for acceptability
Lecture 4:
Premarket Notification 510(k) - continue
Determine risk and contingency plan for potential questions form the reviewer
Points to Consider - Submit your 510(k) to FDA
Interact with FDA staff during review and clearance of your 510(k)
Day 2 Schedule:
Lecture 1:
Premarket Approval (PMA)
Applicable Laws, Regulations and Requirements for PMA
Decide Type of PMA
Compile the Appropriate Information for PMA
Format and Content of your PMA
Suggestions on What to Include or Exclude into your PMA
Tips on authoring a readers friendly and convincing PMA
Lecture 2:
Premarket Approval (PMA) - continue
Critical Review of your prepared PMA for acceptability
Determine risk and contingency plan for potential questions form the reviewer
Points to Consider - Submit your PMA to FDA
Interact with FDA staff during review and clearance of your PMA
Lecture 3:
Investigational Device Exemption (IDE)
Applicable Laws, Regulations and Requirements for IDE
Purpose and Use of Pre-IDE to your advantage
Compile the Appropriate Information for IDE
Format and Content of your IDE
Suggestions on What to Include or Exclude into your IDE
Tips on authoring a reader's friendly and convincing IDE
Lecture 4:
Post Market Requirements for Medical Devices
Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
Mandatory Medical Device Reporting (MDR)
Recalls, Corrections and Removals
Medical Device Tracking
Post Market Surveillance Studies (PSS) mandated under section 522 of the Federal Food, Drug and Cosmetic Act
Post-Approval Studies (PAS) mandated as a condition of approval of a premarket submission � mostly premarket approval (PMA) application
Points to consider - Third Party Inspection by Accredited Persons Program limited to manufacturers who meet certain conditions
Speaker:
Subhash R Patel
Subhash 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: Boston, MA Date: May 5th & 6th, 2016 Time: 08:00 AM to 05:30 PM
Venue: Courtyard Boston Logan Airport
Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA
Price: $1,295.00 (Seminar fee for One Delegate)
Register now and save $200. (Early Bird)
Until March 31, Early Bird Price: $1,295.00 from April 01 to May 03, Regular Price: $1,495.00
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: [email protected]
Website: http://www.globalcompliancepanel.com/
Registration Link - http://bit.ly/preparing-premarket-submissions-Boston
Course "Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA" 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 designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered:
History and background of U.S FDA Laws and Regulations
Classify Your Device
Choose the Correct Premarket Submission for your device
Compile the Appropriate Information for your Premarket Submission
Author and Prepare your Premarket Submission
Submit your Premarket Submission to the FDA
Interact with FDA Staff during Review and Approval
Complete the Establishment Registration and Device Listing
Why should you attend?
The U.S. FDA regulatory 510(k) clearance and Premarket Approval (PMA) process is considered a most stringent and complex. Only a good knowledge of U.S. FDA laws, regulations, and requirements is not sufficient to win a clearance/approval. You are required a proper training on how to set and state regulatory arguments for your device in a most convincing manner to the U.S. FDA reviewer. This 2 days training seminar will walk you through building process of a reader’s friendly but resounding premarket submission and also give you tips and suggestions on how to work effectively with the U.S. FDA officials during review and approval process of your submission.
Areas Covered in the Session:
Food, Drug and Cosmetic Act (FD&C Act)
Title 21 Code of Federal Regulations (CFR) for Medical Devices
Premarket Notification (510k)
Premarket Approval (PMA)
Investigational Exemption Device (IDE)
Points to Consider for preparing a Successful Premarket Submission
Tips and Suggestions on interacting with FDA Officials
Post Market Requirements of Medical Devices
Who Will Benefit:
Marketing Professionals
Research & Development - Product Managers
Quality Assurance and Quality Engineers
Project Managers responsible for United States
Buyers/Purchasing Professionals
Students majoring in Regulatory Affairs
Agenda:
Day 1 Schedule:
Lecture 1:
An overview of U.S. FDA Premarket Regulations
History and background of U.S FDA Laws and Regulations
How to Classify Your Device
Choose the Correct Premarket Submission for your device
Lecture 2:
Premarket Notification 510(k)
Applicable Laws, Regulations and Requirements for 510(k)
Decide Type of 510(k)
Compile the Appropriate Information for 510(k)
Format and Content of your 510(k)
Lecture 3:
Premarket Notification 510(k) - continue
Suggestions on What to Include or Exclude into your 510(k)
Tips on authoring a reader's friendly and convincing 510(k)
Critical Review of your prepared 510(k) for acceptability
Lecture 4:
Premarket Notification 510(k) - continue
Determine risk and contingency plan for potential questions form the reviewer
Points to Consider - Submit your 510(k) to FDA
Interact with FDA staff during review and clearance of your 510(k)
Day 2 Schedule:
Lecture 1:
Premarket Approval (PMA)
Applicable Laws, Regulations and Requirements for PMA
Decide Type of PMA
Compile the Appropriate Information for PMA
Format and Content of your PMA
Suggestions on What to Include or Exclude into your PMA
Tips on authoring a readers friendly and convincing PMA
Lecture 2:
Premarket Approval (PMA) - continue
Critical Review of your prepared PMA for acceptability
Determine risk and contingency plan for potential questions form the reviewer
Points to Consider - Submit your PMA to FDA
Interact with FDA staff during review and clearance of your PMA
Lecture 3:
Investigational Device Exemption (IDE)
Applicable Laws, Regulations and Requirements for IDE
Purpose and Use of Pre-IDE to your advantage
Compile the Appropriate Information for IDE
Format and Content of your IDE
Suggestions on What to Include or Exclude into your IDE
Tips on authoring a reader's friendly and convincing IDE
Lecture 4:
Post Market Requirements for Medical Devices
Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
Mandatory Medical Device Reporting (MDR)
Recalls, Corrections and Removals
Medical Device Tracking
Post Market Surveillance Studies (PSS) mandated under section 522 of the Federal Food, Drug and Cosmetic Act
Post-Approval Studies (PAS) mandated as a condition of approval of a premarket submission � mostly premarket approval (PMA) application
Points to consider - Third Party Inspection by Accredited Persons Program limited to manufacturers who meet certain conditions
Speaker:
Subhash R Patel
Subhash 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: Boston, MA Date: May 5th & 6th, 2016 Time: 08:00 AM to 05:30 PM
Venue: Courtyard Boston Logan Airport
Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA
Price: $1,295.00 (Seminar fee for One Delegate)
Register now and save $200. (Early Bird)
Until March 31, Early Bird Price: $1,295.00 from April 01 to May 03, Regular Price: $1,495.00
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: [email protected]
Website: http://www.globalcompliancepanel.com/
Registration Link - http://bit.ly/preparing-premarket-submissions-Boston
Course "Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA" 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 designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered:
History and background of U.S FDA Laws and Regulations
Classify Your Device
Choose the Correct Premarket Submission for your device
Compile the Appropriate Information for your Premarket Submission
Author and Prepare your Premarket Submission
Submit your Premarket Submission to the FDA
Interact with FDA Staff during Review and Approval
Complete the Establishment Registration and Device Listing
Why should you attend?
The U.S. FDA regulatory 510(k) clearance and Premarket Approval (PMA) process is considered a most stringent and complex. Only a good knowledge of U.S. FDA laws, regulations, and requirements is not sufficient to win a clearance/approval. You are required a proper training on how to set and state regulatory arguments for your device in a most convincing manner to the U.S. FDA reviewer. This 2 days training seminar will walk you through building process of a reader’s friendly but resounding premarket submission and also give you tips and suggestions on how to work effectively with the U.S. FDA officials during review and approval process of your submission.
Areas Covered in the Session:
Food, Drug and Cosmetic Act (FD&C Act)
Title 21 Code of Federal Regulations (CFR) for Medical Devices
Premarket Notification (510k)
Premarket Approval (PMA)
Investigational Exemption Device (IDE)
Points to Consider for preparing a Successful Premarket Submission
Tips and Suggestions on interacting with FDA Officials
Post Market Requirements of Medical Devices
Who Will Benefit:
Marketing Professionals
Research & Development - Product Managers
Quality Assurance and Quality Engineers
Project Managers responsible for United States
Buyers/Purchasing Professionals
Students majoring in Regulatory Affairs
Agenda:
Day 1 Schedule:
Lecture 1:
An overview of U.S. FDA Premarket Regulations
History and background of U.S FDA Laws and Regulations
How to Classify Your Device
Choose the Correct Premarket Submission for your device
Lecture 2:
Premarket Notification 510(k)
Applicable Laws, Regulations and Requirements for 510(k)
Decide Type of 510(k)
Compile the Appropriate Information for 510(k)
Format and Content of your 510(k)
Lecture 3:
Premarket Notification 510(k) - continue
Suggestions on What to Include or Exclude into your 510(k)
Tips on authoring a reader's friendly and convincing 510(k)
Critical Review of your prepared 510(k) for acceptability
Lecture 4:
Premarket Notification 510(k) - continue
Determine risk and contingency plan for potential questions form the reviewer
Points to Consider - Submit your 510(k) to FDA
Interact with FDA staff during review and clearance of your 510(k)
Day 2 Schedule:
Lecture 1:
Premarket Approval (PMA)
Applicable Laws, Regulations and Requirements for PMA
Decide Type of PMA
Compile the Appropriate Information for PMA
Format and Content of your PMA
Suggestions on What to Include or Exclude into your PMA
Tips on authoring a readers friendly and convincing PMA
Lecture 2:
Premarket Approval (PMA) - continue
Critical Review of your prepared PMA for acceptability
Determine risk and contingency plan for potential questions form the reviewer
Points to Consider - Submit your PMA to FDA
Interact with FDA staff during review and clearance of your PMA
Lecture 3:
Investigational Device Exemption (IDE)
Applicable Laws, Regulations and Requirements for IDE
Purpose and Use of Pre-IDE to your advantage
Compile the Appropriate Information for IDE
Format and Content of your IDE
Suggestions on What to Include or Exclude into your IDE
Tips on authoring a reader's friendly and convincing IDE
Lecture 4:
Post Market Requirements for Medical Devices
Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
Mandatory Medical Device Reporting (MDR)
Recalls, Corrections and Removals
Medical Device Tracking
Post Market Surveillance Studies (PSS) mandated under section 522 of the Federal Food, Drug and Cosmetic Act
Post-Approval Studies (PAS) mandated as a condition of approval of a premarket submission � mostly premarket approval (PMA) application
Points to consider - Third Party Inspection by Accredited Persons Program limited to manufacturers who meet certain conditions
Speaker:
Subhash R Patel
Subhash 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: Boston, MA Date: May 5th & 6th, 2016 Time: 08:00 AM to 05:30 PM
Venue: Courtyard Boston Logan Airport
Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA
Price: $1,295.00 (Seminar fee for One Delegate)
Register now and save $200. (Early Bird)
Until March 31, Early Bird Price: $1,295.00 from April 01 to May 03, Regular Price: $1,495.00
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: [email protected]
Website: http://www.globalcompliancepanel.com/
Registration Link - http://bit.ly/preparing-premarket-submissions-Boston