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Jun
21
Thu
FDA 510k Best Practices
Jun 21 @ 3:00 PM – 4:00 PM

LIVE Seminar Online

FDA 510(k) Requirements, Submission, and Clearance: Best Practices

  • Date: June 15, 2017
  • NOTE: This 510(k) LIVE seminar recurrs tri-monthly (every three month) on 3rd Thursdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes

About the Seminar

FDA 510(k) LIVE WebinarThis presentation will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.  On July 28, 2014, FDA issued the finalized 510(k) guidance integrating a total of 400 comments received in response to the Draft Guidance issued on December 28, 2011.  To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes, prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements in your 510(k) submission for successful clearance.

About the Benefits to Attend

  • Gain and receive great guidance on 510(k) preparation, submission and clearance
  • Get the latest information
  • Learn the critical areas and common mistakes
  • Improve your current practice
  • Recognize what is important
  • Become better aware of and get familiar with the 510(k) process
  • Much more

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Device classification
  3. Who is subject to a 510(k)
  4. FDA guidance for 510(k) program, issued on July 28, 2014
  5. What actions require a 510(k) including three types of 510(k)s
  6. How to identify a predicate(s), if any.
  7. 510(k) program (Refuse to Accept Policy) – Compiled RTA Items Cited by FDA
  8. e-Copy Program
  9. Product type-specific 510(k) contents-recently cleared
  10. What to include and address in 510(k) submissions.
  11. 510(k) contents and format
  12. How to present scientific, technical, and/or clinical data.
  13. How to demonstrate substantial equivalence (SE).
  14. How to increase 510(k) submission quality.
  15. How to respond to FDA’s request of additional information.
  16. How to resolve different opinions between the submitter and FDA reviewer(s), if any.
  17. PASS-IT suggestions/recommendations

About the Intended Attendee(s)

  • Professionals from Regulatory Affairs, R&D, Clinical Affairs, Quality
  • Anyone interested in FDA 510(k) submissions.

About the Seminar Speaker

Dr. David Lim
Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates (ensuring to address the applicable requirements) ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$349 

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Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820
Jun 21 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820

  • Date: June 15, 2017
  • NOTE: This seminar recurrs tri-monthly (every three month) on 3rd Thursdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes

About the Seminar

Seminar with Quality, Effectiveness, Satisfaction and SuccessThis online seminar (webinar) is intended to help you get familiar with how to establish an internal audit program of the quality management systems (QMS) for medical device manufacturers in preparation for an FDA inspection under 21 CFR Part 820 or for those who are subject to ISO 13485.

This webinar is also intended to greatly increase your awareness and familiarity with process-based approaches to internal auditing of quality management system requirements including FDA regulations affecting quality records and FDA’s policy on the reports required by the following regulations.

  • 21 CFR 820.20(c) Management review
  • 21 CFR 820.22 Quality audits, and supplier audit reports
  • 21 CFR 820.50(a) Evaluation of suppliers, contractors, and consultants

At the end of the webinar, you will become familiar with the regulatory requirements for establishing an adequate internal audit program while bringing benefits and opportunities to greatly improve your quality management systems and to further save an enormous amount of resources pursuant to ISO 13485 and 21 CFR Part 820.

The speaker will present the regulatory requirements for medical devices in a CAC-SI manner.  *: CAC-SI refers to current, accurate and complete/comprehensive in a systematic, integrated manner.

About the Areas to Be Discussed

  • Statutes and Regulations
  • Definitions
  • ISO 13485 and 21 CFR Part 820 (QSR)
  • Auditing Strategy, Objectives, Planning, Frequency, Duration and Logistics
  • How to Audit Quality Management Systems
  • Various Audit Approaches
  • Quality Systems and Subsystems in ISO 13485
  • Quality Systems and Subsystems under 21 CFR Part 820
  • Comparative Overview of both ISO 13485 and 21 CFR Part 820
  • FDA Regulations (21 CFR Part 11 and 21 CFR 820.180) and FDA Policy on Audit Reports
  • Good Practices: Speaker’s Suggestions and Recommendations
  • Instructor’s unique regulatory guide to provide practical, actionable and sustainable solutions in an integrated, through (PASS-IT) manner.

About the Intended Attendee(s)

  • Professionals from Quality, Regulatory Affairs, R&D, and Clinical Affairs
  • Marketing Professionals
  • Compliance Professionals
  • Legal Counsel
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

David Lim Photo.JPGDr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. Dr. Lim also developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of Advisory Board for Inspection Insider published by FDA News.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

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Jul
2
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Jul 2 all-day

[RECORDED] How to Format Succinct and Comprehensive 510ks and PMAs

The following two products are recorded versions of two day LIVE online seminars.

0823-PMA and 510k Seminars

Day One: How to Format Succinct and Comprehensive 510ks

Product Code “GCS-128R-510k Seminar”

  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality
  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Day Two: How to Format Succinct and Comprehensive PMAs

Product Code “GCS-128R-PMA Seminar”

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality
  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Purchase Options

Option 1: you may send your “request to purchase” by email to Global Compliance Seminar

Option 2: you may request an invoice by email to  Global Compliance Seminar

Option 3: you may purchase online below using a credit card or PayPal. 

510(k) Seminar (RECORDED): $499

PMA Seminar (RECORDED): $599

510(k) and PMA Seminars (Access to Both): $799

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Fundamentals of Regulatory Affairs in Drugs
Jul 2 @ 1:00 PM – 2:00 PM

LIVE Online Seminar Programs in Regulatory Affairs

webinar-orangeFundamentals of Regulatory Affairs in Drugs (“Drug Program“)

Course Description

  1. Each class consists of 60-minutes of online seminar (LIVE or recorded)
  2. There are four classes for each program.
  3. The Drug Program begins on the First Mondays of January, March, May, July, September, November.
    • LIVE | 10:00 AM PST | 01:00 PM | Flexible Scheduling | 60 Minutes 
  4. The Device Program begins on the First Mondays of February, April, June, August, October, December.
    • LIVE | 10:00 AM PST | 01:00 PM EST | | Flexible Scheduling  | 60 Minutes
  5. Price for each program.
    • $799 for one attendee
    • $1,599 for up to three (3) attendees
    • $999 for recorded seminars (access to one attendee for 6 months) for either devices or drugs.
  6. Instructor:  Dr. David Lim, President and Principal of REGULATORY DOCTOR

About the Instructor

David Lim Photo.JPGDr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.  Dr. Lim serves as a Member of the Advisory Board for “Inspection Insider” published by the FDA News as well as for “International Journal of Vaccines and Immunizations.”

Four (4) Online Classes for Drugs

  1. US Laws and Regulations Governing Drugs
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Drug Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational New Drug Application (IND): Content and Format
  4. New Drug Application (NDA): Content and Format

Four (4) Online Classes for Medical Devices

  1. US Laws and Regulations Governing Medical Devices including In Vitro Diagnostic (Medical) Devices (IVDs)
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Medical Device Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational Device Exemption (IDE): Content and Format
  4. Premarket Notification (510(k)) and Premarket Approval (PMA) Application

Registration Options

NOTE: upon registration, you will receive an email to schedule your online classes based on your availability and convenience.

Option 1: you may send your “request to purchase” by email to Global Compliance Seminar

Option 2: you may request an invoice by email to  Global Compliance Seminar

Option 3: you may purchase online below using a credit card or PayPal.

LIVE (one attendee for drugs): $799 

LIVE (≤ 5 attendees for drugs): $1599 

LIVE (one attendee for devices): $799  

LIVE (≤ 5 attendees for devices): $1599 

RECORDED for drugs: $999  

RECORDED  for devices: $999 

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The Fundamentals of Regulatory Affairs
Jul 2 @ 1:00 PM – 2:00 PM

Two LIVE Online Programs in Regulatory Affairs

webinar-orangeThe Fundamentals of Regulatory Affairs for Drugs (“Drug Program“) and Medical Devices (“Device Program“)

Course Description

  1. Each class consists of 60-minutes of online seminar (LIVE or recorded)
  2. There are four classes for each program.
  3. The Drug Program begins on the First Mondays of January, March, May, July, September, November.
    • LIVE | 10:00 AM PST | 01:00 PM | Flexible Scheduling | 60 Minutes 
  4. The Device Program begins on the First Mondays of February, April, June, August, October, December.
    • LIVE | 10:00 AM PST | 01:00 PM EST | | Flexible Scheduling  | 60 Minutes
  5. Price for each program.
    • $799 for one attendee
    • $1,599 for up to three (3) attendees
    • $1,999 for more than four (4) attendees
    • $999 for recorded seminars (access to one attendee for 6 months) for either devices or drugs.
  6. Instructor:  Dr. David Lim, President and Principal of REGULATORY DOCTOR

About the Instructor

David Lim Photo.JPG
Dr. David Lim | Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Drug Program: Four (4) Online Classes

  1. US Laws and Regulations Governing Drugs
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Drug Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational New Drug Application (IND): Content and Format
  4. New Drug Application (NDA): Content and Format

Device Program: Four (4) Online Classes

  1. US Laws and Regulations Governing Medical Devices including In Vitro Diagnostic (Medical) Devices (IVDs)
    • FDA Guidance Documents and FDA-(Non)-Recognized Standards
  2. Medical Device Development, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  3. Investigational Device Exemption (IDE): Content and Format
  4. Premarket Notification (510(k)) and Premarket Approval (PMA) Application

Registration Options

NOTE: upon registration, you will receive an email to schedule your online classes based on your availability and convenience.

LIVE (one attendee for drugs): $799 

LIVE (up to 3 attendees for drugs): $1599 

LIVE (more than 4 attendees for drugs): $1999 

LIVE (one attendee for devices): $799  

LIVE (up to 3 attendees for devices): $1599 

LIVE (more than 4 attendees for devices): $1999 

RECORDED for drugs: $999  

RECORDED  for devices: $999 

The Fundamentals of Regulatory Affairs in Drugs or Medical Devices
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Implementing Global Medical Device Adverse Event Reporting Systems
Jul 2 @ 2:00 PM – 3:00 PM

LIVE Seminar Online

Implementing Global Medical Device Adverse Event Reporting (AER) Systems in EU, Canada and US

  • Date: July 10, 2017
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 60 Minutes

Globe

About the Seminar

This presentation is intended to greatly help global medical device firms implement the global medical device adverse event (AER) reporting systems in EU, Canada, and US.  Even if similar or relevant procedures have been implemented in your firms, it is time to ensure the relevant requirements are under check. To achieve compliance and remain compliant with the global adverse event reporting requirements, it is critical to accurately interpret and understand what requirements apply and how to meet the said requirements.

In this 60-min presentation, the speaker will guide you through the details of the required elements in implementing the global medical device adverse event reporting systems in EU, Canada and US.

About the Areas to Be Discussed

  1. Applicable laws and regulations in EU, Canada, and US
  2. Definitions
  3. Guidance documents-relevant and applicable
  4. Adverse event reporting requirements in EU, Canada, and US
  5. Surveillance and vigilance systems in EU
  6. Mandatory medical device problem reporting requirements in Canada
  7. Mandatory medical device reporting (MDR) requirements in US
  8. Reporting template forms to review
  9. Speaker’s practical tips and cases

About the Intended Attendee(s)

  • Complaint Managers
  • Regulatory Affairs
  • Quality
  • Clinical Affairs
  • R&D engineers and scientists, managers, directors, VPs
  • Compliance and Legal Affairs
  • CRO
  • Auditors and Consultants
  • Senior Management
  • Anyone Interested in Medical Device Complaint Handling Systems

About the Seminar Speaker

David Lim Photo.JPGDr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules, guidance, and regulatory requirements applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by the FDA News. Dr. Lim also contributes to FDA Doctor and FDA Guidance Net.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

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Jul
3
Tue
Understanding Pain Management and Opioids
Jul 3 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Understanding Pain Management and Opioids: FDA Regulations, Generics and Recent Approvals

  • Date: April 3, 2018
  • NOTE: This seminar recurrs tri-monthly (every three month) on 1st Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes

About the Seminar

Pain Management OpioidsThe United States Food and Drug Administration (FDA) recently expressed deep concerns over the growing epidemic of opioid dependence, overuse and abuse on families and communities.

Opioids as prescription drugs are used to reduce chronic pain.  Opioids offer both great benefits and also serious risks, potentially causing serious harm (addiction, overdose and even death) when misused or abused.

This seminar is intended to help industry and professionals to better understand FDA roles and regulation governing controlled substances (opioids) used for pain management. This seminar is also intended to help industry get better familiar with FDA’s recent activity and regulatory expectations  for drugs (opioids) including generic opioids and recent approvals for pain management.

In this 60-min presentation, the speaker will guide you through the details of FDA roles, regulations, generic opioids and recent FDA approvals for chronic pain management.

About the Areas to Be Discussed

  • FDA Laws and Regulations
  • Definitions
  • Learn About Controlled Substances
  • Regulation of Abuse-Deterrent Opioid Medications
  • Opioid Misuse & Abuse
  • Prevention of Opioid Abuse and Appropriate Pain Management
  • New Labeling Requirements
  • FDA Approved Generic Opioids
  • Recent FDA Approvals for Pain Management Drugs
  • Best Practices

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Medical Doctors and Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the advisory board for inspection insider at FDA News.

Registration Options

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $799 

LIVE (≥ 5 attendees): $999 

LIVE & Recorded$399 

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Jul
4
Wed
FDA Pre-Submission and 510k Best Practices
Jul 4 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

FDA Pre-submission and 510(k); Best Practices

  • Date: November 2, 2016
  • NOTE: This 510(k) LIVE seminar recurrs monthly on 1st Wednesdays.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes.

FDA 510ks

About the Seminar

This presentation will walk you through how to prepare and submit a pre-submission package as well as a traditional premarket notification [510(k)] for successful clearance from US FDA.  The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes including pre-submission (Q-submission), prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements (“Best Practices: Dos and Don’ts”) in your Q-submission as well as 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s pre-submission, 510(k) preparation and submission for successful clearance in an efficient and effective manner.

About the Areas to Be Discussed

  • Statute(s) And Regulations
  • Definitions
  • Device Classification And Predicates
  • 510(k) Program
  • When 510(k)s Are Required
  • Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
  • Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
  • Substantial Equivalence: Factors to Consider and Special Considerations
  • Addressing e-Copy And RTA Policy Requirements
  • Applicable Standards and Guidance
  • 510(k) Contents And Format
  • Common Pitfalls and How to Prevent Them
  • What to Ensure While Preparing Your Q-Submission and a 510(k) Application
  • Responding to FDA’s Request of Additional Information.
  • Resolving Different Opinions and Interpretations
  • Best Practices for a Q-submission
  • Best Practices for a 510(k) Preparation, Submission and Clearance
  • Speaker’s PASS-IT Suggestions: Best Practices

About the Benefits to Attend

  • Gain and receive great guidance on 510(k) preparation, submission and clearance
  • Get updated with the latest information and tips
  • Learn the critical areas and common mistakes
  • Improve your current practice
  • Recognize what is important
  • Become better aware of and get familiar with the 510(k) process
  • Much more

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Marketing
  • Consultants
  • Legal Counsel
  • Compliance Officers
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

DavidLimUpdated_Cropped1
FDA 510(k) Consultant Speaker

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the Advisory Board for Inspection Insider at FDA News.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

Share
Jul
12
Thu
FDA 510k Requirements, Submission, and Clearance
Jul 12 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

FDA 510(k): Requirements, Submission, and Clearance

  • Date: September 10, 2015
    • NOTE: This 510(k) LIVE seminar recurrs bi-monthly on second Thursdays.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

FDA 510(k) LIVE WebinarThis presentation will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes, prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements in your 510(k) submission for successful clearance.

About the Benefits to Attend

  • Gain and receive great guidance on 510(k) preparation, submission and clearance
  • Get the latest information
  • Learn the critical areas and common mistakes
  • Improve your current practice
  • Recognize what is important
  • Become better aware of and get familiar with the 510(k) process
  • Much more

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Device classification
  3. Who is subject to a 510(k)
  4. What actions require a 510(k) including three types of 510(k)s
  5. How to identify a predicate(s), if any.
  6. 510(k) program (Refuse to Accept Policy) – Compiled RTA Items Cited by FDA
  7. e-Copy Program
  8. Product type-specific 510(k) contents-recently cleared
  9. What to include and address in 510(k) submissions.
  10. 510(k) contents and format
  11. How to present scientific, technical, and/or clinical data.
  12. How to demonstrate substantial equivalence (SE).
  13. How to increase 510(k) submission quality.
  14. How to respond to FDA’s request of additional information.
  15. How to resolve different opinions between the submitter and FDA reviewer(s), if any.
  16. PASS-IT suggestions/recommendations

About the Intended Attendee(s)

  • Professionals from Regulatory Affairs, R&D, Clinical Affairs, Quality
  • Anyone interested in FDA 510(k) submissions.

About the Seminar Speaker

David Lim Photo.JPGDr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates (ensuring to address the applicable requirements) ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

Option 1: you may send your “request to purchase” by email to Global Compliance Seminar

Option 2: you may request an invoice by email to  Global Compliance Seminar

Option 3: you may purchase online below using a credit card or PayPal. 

LIVE (one attendee): $199 

Recorded: $249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded: $299 

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Jul
13
Fri
LIVE 510k Webinar
Jul 13 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

FDA 510(k): Preparation, Submission, and Clearance

  • Date: November 11, 2016
  • NOTE: This 510(k) LIVE seminar recurrs monthly on 2nd Fridays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 60 Minutes.

FDA 510ks

About the Seminar

This presentation will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).  In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).

Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes, prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.

In this 60-min presentation, the speaker will guide you through the details of the required elements in your 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s 510(k) preparation, submission and clearance in an efficient and effective manner.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Device classification
  3. Who is subject to a 510(k)
  4. What actions require a 510(k) including three types of 510(k)s
  5. How to identify a predicate(s)
  6. 510(k) preparation compliant with eCopy and revised RTA policy (effective as of October 1, 2015)
  7. 510(k) content and format
  8. Writing a cover letter: importance
  9. What to include and address in 510(k) submissions
  10. FDA de novo process – current good practices
  11. How to present scientific, technical, and/or clinical data
  12. How to demonstrate substantial equivalence (SE)
  13. How to increase 510(k) submission quality
  14. How to respond to FDA’s request of additional information
  15. How to resolve different opinions between the submitter and FDA reviewer(s)
  16. Speaker’s PASS-IT suggestions/recommendations

About the Benefits to Attend

  • Gain and receive great guidance on 510(k) preparation, submission and clearance
  • Get updated with the latest information and tips
  • Learn the critical areas and common mistakes
  • Improve your current practice
  • Recognize what is important
  • Become better aware of and get familiar with the 510(k) process
  • Much more

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Marketing
  • Consultants
  • Legal Counsel
  • Compliance Officers
  • Senior Management
  • Anyone interested in the topic.

About the Seminar Speaker

DavidLimUpdated_Cropped1
FDA 510(k) Consultant Speaker

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded: $299 

Share