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May
7
Tue
Risk Management for Medical Devices and IVDs Systematic and Holistic Approaches
May 7 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

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

  • Date: May 6, 2019
  • 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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May
9
Thu
Implementing Medical Device Complaint Handling Systems
May 9 @ 3:00 PM – 4:00 PM

LIVE Online Seminar

Implementing Medical Device Complaint Handling Systems

  • Date: May 9, 2019
  • 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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Complaint Handing and Medical Device Reporting
May 9 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Title: Complaint Handling and Medical Device Reporting (MDR)

  • Date: May 9, 2019
  • This seminar recurs tri-monthly on second Thursdays.
  • Time: 01:00 PM PST | 04:00 PM EST
  • Duration: 60 Minutes

Complaint and MDR

About the Seminar

As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US.

FDA frequently cites in 483s upon establishment inspections and subsequently warning letters issued to the firms as follows.

…Your failure to establish and maintain adequate complaint handling or medical device reporting procedures…”

This presentation is intended to help global medical device firms and stakeholders adequately implement US FDA-compliant medical device complaint handling and medical device reporting (MDR) 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 be adequate and compliant. To achieve compliance and to remain compliant with the FDA-compliant complaint handling and medical device reporting, it is imperative that the firms accurately understand, interpret, and implement the requirements for handling all complaints (electronic, written, or ORAL) and medical device reporting to be better sustainable as evident from a recent case.  

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 and medical device reporting systems so that you can ensure your firms adequately establish and maintain the applicable systems in a PASS-IT manner.

About the Areas to Be Discussed

  1. Applicable Laws and Regulations
  2. Definitions
  3. Requirements for Complaint Handling
  4. Requirements for Medical Device Reporting
  5. Applicable Processes and Procedures
  6. Key Elements in the Procedures: Complaint Handling and MDR
  7. What to Do When a Complaint Is Received
  8. What/How/When to Investigate a Complaint
  9. Complaints Investigation and Documentation
  10. Medical Device Reporting
  11. How to Determine Reportable Events
  12. Establishing Reportability Criteria
  13. Additional Documentation Requirements for MDR
  14. Mistakes and How to Avoid Mistakes and 483s
  15. Relationships between Complaint Handling, MDR, and CAPA
  16. Enforcement Case Studies
  17. Improving Our Awareness and Continuous Improvement
  18. Speaker’s PASS-IT suggestions and recommendations

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 | Complaint/MDR 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.

Registration Options

LIVE (one attendee): $199 

Recorded$249 

LIVE (≤ 5 attendees): $599 

LIVE (≥ 6 attendees): $999 

LIVE & Recorded$299 

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May
10
Fri
Good Social Media Practices to Avoid FDA Actions
May 10 @ 1:00 PM – 2:00 PM

LIVE Online Seminar

Establishing FDA-Compliant Social Media Practices to Avoid FDA Actions

SocialMediaCheckList

  • Date: May 10, 2019
    • 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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How to Most Effectively Prepare for the US RAC Exam
May 10 @ 2:00 PM – 3:30 PM

LIVE Online Seminar

How to Most Effectively Prepare for the US RAC Exam

  • Date: May 10, 2019
  • Time: 11:00 AM PST | 02:00 PM EST
  • Duration: 90 Minutes

About the Seminar

The keys of successHaving a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. 

*: RAC stands for Regulatory Affairs Certification. In this case, it refers to the US RAC examination.  

Understanding what and how to study the relevant subjects is one of the first steps and is considered to be the most effective strategy.  An effective preparation of the RAC examination can save a significant amount of your resources (time, energy and money) and beyond (sometimes, saving some level of embarrassment).

This  seminar is intended to help you effectively prepare for the US RAC examination using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive study and understanding in a Systematic, Integrated Manner.

In this 90-min presentation, the speaker will guide you through the details of the contents for you to study (namely, WHAT and HOW) and grasp so that you can be well-prepared for the RAC exam.  

At the end of the presentation, you should be able to come up with your customized, well-guided, actionable strategy to most effectively prepare for and pass the US RAC examination. 

About the Areas to Be Discussed

  • 1st 45 Minutes
    • Overview of the US RAC Exam
    • Subject Areas
    • Applicable Laws and Regulations
    • Areas in Pharmaceuticals
    • Good Laboratory Practice (GLP)
    • Good Clinical Practice (GCP)
    • Good Manufacturing Practices (cGMPs)
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • FDA Guidance Documents
    • Review of Practice Questions
  • 2nd 45 Minutes
    • Subject Areas for Biologics and Medical Devices
    • Applicable Laws and Regulations for Biologics and Medical Devices
    • Biological Products
    • Licensing Biologics
      General Biological Products Standards
    • Investigational Device Exemption
    • Premarket Notification (510(k))
    • Premarket Approval (PMA)
    • Good Manufacturing Practices (cGMPs) for Medical Devices
    • FDA Guidance Documents
    • Review of Practice Questions

NOTE:  Your attendance of this seminar will save you a significant amount of time, energy and efforts while preparing for your successful RAC examination.  

About the Intended Attendee(s)

  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Anyone interested in the topic

About the Seminar Speaker

DavidLimUpdated_Cropped1
Dr. David Lim, Ph.D., RAC, ASQ-CQA

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 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. 

Recent Testimonials

  • I want to thank you for an excellent seminar on US RAC Prep. – RA Professional with 15 Years Experience in Pharmaceutical Industry
  • I found the presentation slides to be quite thorough and extremely useful. – Regulatory Affairs Manager
  • The seminar was very helpful. – RA Professional
  • I found it very helpful for my preparation – Sr. RA Professional.
  • David Lim’s seminar helped me develop a strategy for pasting the US exam. I took the exam in the early part of Nov 2015 and left the exam with confidence his program thoroughly prepared me for the exam’s tricks, and nuances. – RA Professional in Pharmaceutical Industry
  • I just received my RAC-US in December, and I am very happy. This would not have been possible without your help and support. Thank you very, very much. – Regulatory Consultant
  • I would like to let you know that I passed the RAC (US) exam. I am very thankful for your kind advice and for your PowerPoint presentation during my exam preparation. They were very helpful. I am planning to make a full time career in regulatory affairs. – Associate Director/Regulatory Affairs Professional
  • Excellent slides, you put together a lot of very useful information! – Director of Business Development

Registration Options

Date: Recently Recorded Version

  • Recorded$299 

Date:  April 12, 2019

Time: 09:00 AM PST | 12:00 PM EST

Duration: 90 Minutes

LIVE (one attendee): $299 

Recorded$349 

LIVE (≤ 4 attendees): $499 

LIVE (≥ 5 attendees): $799 

LIVE & Recorded$399 


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LIVE 510k Webinar
May 10 @ 2:00 PM – 3:00 PM

LIVE Online Seminar

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

  • Date: April 12, 2019
  • 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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Developing and Implementing a Global Regulatory Plan and Strategy
May 10 @ 4:00 PM – 5:00 PM

LIVE Online Seminar

Developing and Implementing a Global Regulatory Plan and Strategy

  • Date: May 10, 2019
  • NOTE: This seminar recurrs bi-monthly (every other month) on 2nd Fridays.
  • 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 MinutesCompass

About the Seminar

Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued.  Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy 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 regulatory plan and strategy.  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. Applicable Laws and Regulations in EU, Canada, and US
  2. Questions and Issues to Identify and Address
  3. Interfacing:  Roles and Benefits
  4. Alignments between Functional Departments/Groups
  5. What Is Critical When Implementing Global Regulatory Intelligence Program
  6. Mapping Regulatory Requirements and Pathways
  7. When/How to Prevent Costly Mistakes
  8. Best Approaches: What to Integrate
  9. Practical, Actionable, and Strategic Solutions (PASS)
  10. Speaker’s Experience and Actual Cases

About the Intended Attendee(s)

  • Regulatory Affairs
  • Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
  • 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 served as a member of the advisory board for inspection insider published by the 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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May
13
Mon
510k Drafting Seminars
May 13 @ 3:00 PM – 4:00 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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FDA Inspection Preparation and Readiness
May 13 @ 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: May 13, 2019
  • 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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May
14
Tue
510k Drafting Seminars
May 14 @ 3:00 PM – 4:00 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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