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Dec
3
Mon
Fundamentals of Regulatory Affairs in Medical Devices
Dec 3 @ 1:00 PM – 2:00 PM

LIVE Online Seminar Programs in Regulatory Affairs

webinar-orangeThe Fundamentals of Regulatory Affairs in 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 or $1,999 for up to five (5) 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.

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 

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The Fundamentals of Regulatory Affairs
Dec 3 @ 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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Dec
4
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Dec 4 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Risk Management for Medical Devices and IVDs: Systematic and Holistic Approaches

  • Date: June 6, 2017
  • NOTE: This LIVE seminar recurrs bi-monthly (every other month) on 1st Tuesdays.
  • Your payment would apply for the next upcoming LIVE online seminar unless indicated otherwise after registration.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to discuss systematic and holistic approaches for medical device risk management including in vitro diagnostic medical devices (IVDs) applicable to medical device and IVD manufacturers and stakeholders.This seminar is further intended to discuss the impact of ISO 14971 on the risk management and risk-based decision making processes including its application to ISO 13485. This seminar will help attendees understand risk management tools, methods and processes applicable to the firms.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy.In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for medical devices including IVDs.

About the Areas to Be Discussed

  1. Applicable statute(s), regulations, and definitions
  2. Risk management policy
  3. Risk management plan
  4. Risk identification, analysis and evaluation
  5. Risk analysis (severity, probability and detectability)
  6. Risk control measures
  7. Risk mitigation
  8. Risk management tools and methods
  9. ISO 14971:2007 and EN ISO 14971:2012
  10. ISO 13485:2003 and EN ISO 13485:2012
  11. Risk analysis and design control
  12. Risk analysis versus FMEA
  13. Risk analysis versus usability
  14. How to integrate risk management into the device design and development
  15. Doing risk management right without wasting resources
  16. Practical aspects (value) of risk management
  17. Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
  18. Risk management for IVDs
  19. Risk analysis versus IEC 60601-1
  20. Relationship between risk management, complaint handling, MDR and CAPA

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

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 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 

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Dec
5
Wed
FDA Pre-Submission and 510k Best Practices
Dec 5 @ 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 

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Dec
10
Mon
Overview of the EMA Marketing Authorization Applications for Medicinal Products
Dec 10 @ 11:00 AM – 12:00 PM

LIVE Seminar Online

Overview of the EMA Marketing Authorization Applications (MAAs) for Medicinal Products for Human Use in EU

  • Date: December 11, 2017 or email us to schedule a date and time
  • 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

510(k) Success Path

About the Seminar

This seminar is intended to present an overview of the regulatory process for marketing authorization applications (MAAs) for medicinal products for human use to the European Medicines Agency (EMA).

The speaker will present European Union (EU)’s legislation and regulations governing medicinal products.  In particular, the regulatory requirements to obtain an MAA for medicinal products for human use will be presented in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details of the process and requirements to obtain an MAA in the European Union.

About the Areas to Be Discussed

  1. Applicable laws and regulations
  2. Definitions
  3. Marketing authorization application (MAA) process: centralized, mutual recognition agreements and decentralized.
  4. Pre-submission regulatory guidance for various product types
  5. Pre-submission procedural guidance
  6. Good manufacturing practices
  7. Quality by design
  8. Application templates
  9. Good practices for MAA preparation and submission
  10. Speaker’s practical, actionable and sustainable solutions
  11. Much more

About the Intended Attendee(s)

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

About the Seminar Speaker

David Lim Photo.JPG

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) 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 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. Dr. Lim also contributes to FDA Guidance.net, providing FDA guidance information for free to the FDA regulated industry.

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 (≤ 5 attendees): $599 
  • LIVE (≥ 6 attendees): $999 
  • LIVE & Recorded$299 
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Quality Risk Management for Drugs Biologics and Biosimilars-Systematic and Holistic Approaches
Dec 10 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Quality Risk Management for Drugs and Biologics: Systematic and Holistic Approaches

  • Date: June 12, 2017
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Mondays.
  • Time: 12:00 PM PST | 03:00 PM EST
  • Duration: 60 Minutes

510(k) Success Path

About the Seminar

This seminar is intended to discuss systematic and holistic approaches of quality risk management (QRM) for pharmaceutical industry (drugs, biosimilars, and biologics).

This seminar is further intended to discuss how quality risk management can be effectively integrated into a quality system (QS) in the pharmaceutical industry.

This seminar will help attendees understand risk management principles, risk management tools, methods and processes applicable to the pharmaceutical industry.  In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy integrated into the quality system.

In this 60-min presentation, the speaker will guide you through the details of how to implement the systematic and holistic risk management for drugs, biosimilars and biologics.

About the Areas to Be Discussed

  1. Applicable statute(s), Regulations, and Definitions
  2. Risk Management (RM) Process – Systematic and Integrated
  3. RM Principles
  4. Risk Management Tools and Methods (PHA, HAZOP, HACCP, FTA, FMEA, FMECA)
  5. Risk Ranking
  6. How to Facilitate Quality Risk Management
  7. Common Mistakes and How to Prevent Common Pitfalls
  8. Risk Control Measures
  9. Risk Communication – How
  10. RM Applications for Operations, R&D, Materials, Facilities, Utilities, Equipment, Manufacturing, Labeling and Packaging, Laboratory Studies and Quality Control.
  11. Doing RM Right Without Wasting Resources
  12. Practical Aspects (Value) of Risk Management
  13. Relationship with Other Quality Subsystems
  14. Implementing RM in an Efficient and Effective Manner.
  15. Speaker’s Practical Guide

About the Intended Attendee(s)

  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Quality
  • Senior Management
  • Consultants
  • Contractors
  • Anyone Interested in the Risk Management

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 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 

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FDA Inspection Preparation and Readiness
Dec 10 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

FDA Inspection Preparation and Readiness: the Top 20 Most Common GMP Deficiencies for Device Manufacturers

  • Date: June 12, 2017
  • NOTE: This seminar recurrs bi-monthly (every other 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 | 2:00 PM EST
  • Duration: 60 Minutes

About the Seminar

This seminar is intended to discuss FDA inspection practices and the most common deficiencies for medical device manufacturers including in vitro diagnostic device manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past seven (8) years.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.

This presentation will provide great opportunities to become familiar with the FDA inspection practices and the most common top twenty (20) deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.

The speaker will share his PASS-IT recommendation/suggestions.

About the Areas to Be Discussed

  1. Applicable Laws and Regulation
  2. FDA Manuals and Inspection Guides
  3. Hosting an FDA Inspection
  4. Field Management Directives
  5. Inspection Types and Categories
  6. Inspection Classification
  7. FDA Forms 482 and 483
  8. Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device Manufacturers
  9. How to Identify Gaps between FDA Expectations and Firms’ Current Level of Compliance
  10. What/How to Prepare for and Manage an FDA Inspection
  11. How to Communicate Before, During and After inspection: Dos and Don’ts
  12. Common Mistakes and How to Prevent Them
  13. How to Most Effectively Use Close Out Meeting
  14. Responding to 483s, If Issued
  15. How to Communicate with Emotional Intelligence
  16. Employee Training
  17. Actual FDA Inspection Case Studies (Reports)
  18. Speaker’s PASS-IT Suggestions/Recommendations
  19. Conclusion

About the Intended Attendee(s)

  • Quality
  • Manufacturing
  • Regulatory Affairs
  • R&D
  • Clinical Affairs
  • Senior Management
  • Consultants
  • Contractors
  • Compliance Officers
  • Anyone Interested in the FDA Inspection

About the Seminar Speaker

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 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 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.

Registration Options

LIVE (one attendee): $249 

Recorded$299 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$349 

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PMA Drafting Seminars
Dec 10 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

PMA Drafting Seminars

  • Date: Starting on April 9, 2018
  • NOTE: This seminar recurrs bi-monthly (every other month)
  • February, April, June, August, October and December
  • Time: 2nd Mondays at 11:00 AM EST OR 2:00 PM EST OR by scheduling at your convenience
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Duration: 90 Minutes

PMA Drafting Seminars

Learning LIVE How To Draft a PMA Like a Pro

I.   Scope

This PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

II.   About the Seminar 

  • PMA drafting track runs for eight weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
    • One class per week
    •  PMA drafting: second Mondays at 11 AM or 03 PM EST (90 minutes)
      • For PMA drafting: seminar begins bi-monthly.
    • Flexible scheduling – it can be adjusted on a needed basis..

III.   About the PMA Drafting Track

  • PMA drafting track is comprised of eight (8) LIVE webinars.
  • PMA format and contents
  • PMA submission quality issues
  • Substantive review of previous PMA materials disclosed by FDA
  • Each LIVE webinar runs for 60 minutes.

IV.   Cost

  • PMA drafting track is $2,499.
  • It is payable upon registration.

V.  About the 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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.

VI. Registration Options

  • LIVE (one attendee): $2,499 
  • Recorded$2,999 
  • LIVE (≤ 3 attendees): $6,999 
  • LIVE (≥ 4 attendees): $8,999 
  • LIVE & Recorded$3,499 
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Dec
11
Tue
510k Drafting Seminars
Dec 11 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Learning LIVE How To Draft a 510(k) Like a PRO

  • Date: recommended to contact us to schedule the 510(k) seminar (online)
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Mondays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 11:00 AM ET | 03:00 PM ET or flexible scheduling is available for your convenience
  • Duration: 60 Minutes

510k

Scope

This 510(k) or PMA drafting LIVE online seminars (“Seminar”) are specifically designed to help regulatory affairs and other professionals draft a premarket notification [510(k)] submission or premarket approval (PMA) application in an efficient and effective manner. This seminar is intended to greatly help you identify applicable regulatory requirements, become better articulate and address regulatory questions and requirements in a timely and effective manner.

This seminar will also be very helpful to those who are willing to learn and develop necessary skills, knowledge, and expertise in understanding regulatory questions including how to most effectively address those questions.

About the Seminar 

  • 510(k) drafting track runs for five weeks as a small group (2-5 people or a group).
  • Each class is scheduled during the weekdays.  Curriculum may be subject to slight change on a needed basis.
  • One class per week
  • For 510(k) drafting: seminar begins bi-monthly or by scheduling 
  • Flexible scheduling – it can be adjusted on a needed basis.
  • 510(k) drafting:  second Mondays at 11 AM or 03 PM EST (60 minutes) – January, March, May, July, September and November

NOTE:

About the 510(k) Drafting Track

510(k) drafting track is comprised of five (5) LIVE webinars.

  1. 510(k) format and contents
  2. Guidances and standards
  3. Pre-submission/Q-subs; FDA-cleared 510(k)s
  4. FDA-cleared 510(k)s
  5. Technical issues and practical tips

Each 510(k) LIVE webinar runs for 60 minutes.

Cost

  • 510(k) drafting track is $1,499.
  • It is payable upon signing.

About the 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 immediate use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first 510(k) and PMA drafting 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 FDA News.

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): $1,499 

Recorded$1,999 

LIVE (≤ 3 attendees): $3,999 

LIVE (≥ 4 attendees): $5,999 

LIVE & Recorded$2,499 

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Establishing an FDA-Compliant UDI System
Dec 11 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Establishing an FDA-Compliant UDI System

  • Date: June 13, 2017
  • NOTE: This seminar recurrs tri-monthly (every three month) on 2nd Tuesdays.
  • Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
  • Time: 10:00 AM PST | 01:00 PM EST
  • Duration: 60 Minutes

About the Seminar

FDA UDI-LabelThis seminar is intended to help you effectively implement a unique device identification (UDI) system (UDI system) based on the final rules issued on September 20, 2013 and published in federal register on September 24, 2013. This final rule is effective 90 days after date of publication in the federal register.  Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement.  The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself.

The speaker will present how to implement the UDI system requirements in a CAC-SI manner.

*: CAC-SI refers to current, accurate and comprehensive in a systematic, integrated manner.

In this 60-min presentation, the speaker will guide you through the details.  You will have opportunities to bring great value and benefits to your firm’s implementation of a UDI system in an efficient and effective manner.

About the Areas to Be Discussed

  • Applicable Statute(S), Regulations and Enforcement Authority
  • Definitions
  • UDI Development History
  • UDI Final Rules: Technical Requirements and Changes Made
  • When to Use a UDI and When to Discontinue Its Use
  • UDI System Requirements including Technical Standards
  • Requirements for a Unique Device Identifier
  • FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
  • UDI Rules: Applicability
  • UDI Rules: Exceptions and Alternatives
  • Devices at a Retail Store
  • Devices Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and Hospitals
  • Devices Labeled Prior to Compliance Dates
  • Devices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)
  • Class I Devices: cGMPs Exempted
  • When to Request Exceptions and Modifications
  • Which Devices Not Required to Have a Production Identifier
  • Direct Marking Requirements and Revised Changes
  • Requirements for Stand-Alone Software
  • Use and Discontinuation of a UDI and When to Use a New UDI
  • Compliance Dates for the Applicable Requirements Over Seven (7) Years
  • Device Identifier Formats including Dates
  • Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
  • Impact of the Final Rules to Many Business Areas/Processes
  • Changes in Device Design, Documentation and Manufacturing Processes
  • Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
  • Conclusion

About the Intended Attendee(s)

  • R&D Scientists, Managers, Directors, and VPs
  • Regulatory Affairs and Compliance Professionals
  • Clinical Affairs Professionals
  • Quality Professionals
  • Consultants
  • Legal and Compliance Officers
  • Marketing Professionals
  • Senior Management
  • Anyone Interested in the Subject

About the Seminar Speaker

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 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.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 4 attendees): $699 

LIVE (≥ 5 attendees): $899 

LIVE & Recorded$299 

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