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Jan
26
Fri
Developing and Implementing an Effective SOP in Healthcare Industry
Jan 26 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

Developing and Implementing an Effective SOP in Healthcare Industry

  • Date: January 27, 2017
  • NOTE: This seminar recurrs tri-monthly (every three month) on 4th Fridays.
  • 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

Writing Effective SOPsAbout the Seminar

In healthcare business environments, it is critical to define, document and implement an effective standard operating procedure (SOP) to ensure relevant business practices are done in a consistent, reliable, and effective manner – each and every time.  Implementing an effective SOP has been under-valued by business owners for various reasons (e.g., due to perception for no need).

Effective SOPs can significantly help healthcare business owners save an enormous amount of time, energy, financial resources and beyond.

This webinar is intended to help you develop and implement guidelines for developing and implementing an effective SOP using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive (e.g., SOP) in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your practical and actionable SOP.  At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.

About the Areas to Be Discussed

  1. SOPs: Definitions and Why?
  2. When are SOPs needed?
  3. Who should develop an SOP?
  4. Requirements in the SOPs
  5. Writing an effective SOP
  6. Contents and format of SOPs
  7. How to implement SOPs
  8. Training employees with the SOPs
  9. Practical, Actionable, and Sustainable Solutions (PASS)
  10. Speaker’s Experience and Actual Cases

About the Intended Attendee(s)

  • Healthcare Business Owners
  • Recruiters
  • Consultants
  • Regulatory Affairs Professionals
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • 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): $199 

Recorded$249 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$299 

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Feb
5
Mon
How to Format Succinct and Comprehensive 510ks and PMAs
Feb 5 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 Medical Devices
Feb 5 @ 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
Feb 5 @ 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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Feb
6
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
Feb 6 @ 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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Feb
7
Wed
FDA Pre-Submission and 510k Best Practices
Feb 7 @ 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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Feb
8
Thu
Establishing an FDA-Compliant UDI System
Feb 8 @ 12:00 PM – 1:00 PM

LIVE Online Seminar

Establishing an FDA-Compliant UDI System

  • Date: October 8, 2015
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd 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 MinutesGUDID Attributes UDI Labels

About the Seminar

This 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

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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Implementing Medical Device Complaint Handling Systems
Feb 8 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing Medical Device Complaint Handling Systems

  • Date: April 13, 2017
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd 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

0937-Complaint HandlingThis presentation is intended to help global medical device firms and stakeholders adequately implement FDA-compliant medical device complaint handling systems.  Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check.

To achieve compliance and to remain compliant with the FDA-compliant complaint handling systems, it is imperative that the firms accurately interpret, understand, and implement the requirements for handling all complaints (electronic, written, or ORAL).

In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling systems in your firms.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations
  2. Definitions
  3. Regulatory Requirements and Compliance
  4. Applicable Processes and Procedures
  5. What to Do When a Complaint Is Received
  6. What/How/When to Investigate a Complaint
  7. Complaint Investigation: Contents of Records
  8. Adjudicating Complains
  9. Implementing Interactive Systems (Complaints, MDR, and CAPA)
  10. Numerous Case Studies
  11. Speaker’s PASS-IT suggestions and recommendations
  12. Conclusion

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

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, 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 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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Feb
9
Fri
Good Social Media Practices to Avoid FDA Actions
Feb 9 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Establishing FDA-Compliant Social Media Practices to Avoid FDA Actions

SocialMediaCheckList

  • Date: December 9, 2016
    • NOTE: This seminar recurrs bi-monthly on second Fridays.
    • Time: 09:00 AM PST | 12:00 PM EST
  • Duration: 60 Minutes.

About the Seminar

This seminar is intended to help you adequately implement good social media practices to avoid FDA enforcement actions for potential misbranding of your prescription drugs (humans and animals), biologics, and medical devices including other healthcare products (dietary supplements, cosmetics and OTCs).

On June 27, 2014, FDA issued an untitled letter to a pharmaceutical company concerning the firm’s sponsored link on the internet search engine.  FDA states:

The sponsored link provides evidence that the drug is intended for a new use for which it lacks approval, and for which its labeling does not provide adequate directions for use, which renders the drug misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or otherwise makes its distribution violative.

The U.S. Food and Drug Administration (FDA) reviewed the firm’s sponsored link on the Google as part of the FDA’s routine monitoring and surveillance program by the Office of Prescription Drug Promotion (OPDP). It is imperative that firms ensure their compliance to the applicable laws and regulations when they provide drug or device information to the public through social media.

In this presentation, the speaker will discuss what to consider and how to establish your good social media practices while ensuring your compliance to the laws and regulation to avoid potential FDA enforcement actions.

This 60 min seminar presentation will provide you a great opportunity to understand FDA’s perspective on social media practices covered in FDA’s recent guidances. You will learn about the various considerations that pharmaceutical and medical device firms need to consider when establishing procedures for social media practices.

About the Areas to Be Discussed

  • Applicable Laws and Regulations
  • Definitions
  • FDA’s Current Thinking and Perspectives
  • FDA’s Three (3) Social Media Guidances Issued in December, 2011 and June, 2014
  • Best Social Media Practices
  • FDA Enforcements: Recent Cases
  • Advertising and Promotion on Social Media – Twitter, Facebook, YouTube, WordPress and Blogger
  • PASS-IT Recommendations: Dos and Don’ts

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 premarket notification 510(k) and premarket approval (PMA) 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

  • Option 2: you may request an invoice by email to  Global Compliance Seminar
  • Option 3: you may purchase below using a credit card or PayPal below. 

LIVE (one attendee): $199 

Recorded: $249 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded: $299 

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LIVE 510k Webinar
Feb 9 @ 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 

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