Dr. David Lim
Dr. David Lim
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics 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 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 pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.
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Medical Device Laws and Regulations in Asia – China, India, Japan and Korea
This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, India, Japan, and Korea. The medical devices are currently one of the fastest growing industries. The current knowledge and accurate... -
Opioids and Pain Management – FDA Regulations, Generics and Recent Approvals
The United States Food and Drug Administration (FDA) recently expressed deep concerns over the growing epidemic of opioid dependence, overuse and abuse on families and communities. Opioids as prescription drugs are used to reduce chronic pain. Opioids offer both... -
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
To achieve and remain compliant with the adequate use of the Excel spreadsheet in FDA-regulated environments, it is critical that laboratory personnel and managers including IT professionals understand and accurately interpret the applicable requirements. This is necessary to ensure... -
Establishing FDA-Compliant Social Media Practices to Avoid FDA Actions
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... -
Big Data in FDA-Regulated Industry – Best Practices for Systematic Use
In recent years, big data and information is available in public domain. Adequate use of such big data in FDA-regulated industry has become critically important to exercise best practices. In this presentation, the speaker will provide a great opportunity... -
Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo
This seminar presentation will provide great opportunities to get familiar with the “Best Practices” on how to obtain FDA’s constructive feedback on regulatory questions prior to preparing for and submitting a 510(k) and de novo request. In particular, the... -
FDA Off-Label Promotion Guidelines
The United States Food and Drug Administration (FDA) regulates labeling and advertisement for prescription drugs and medical devices among other things. The advertising for nonprescription or over-the-counter (OTC) drugs falls under the jurisdiction of another federal agency. In pharmaceutical... -
FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs
The United States Food and Drug Administration (FDA) can approve small molecule drugs and some biologics under the regulatory pathway 505(b)2. The 505(b)2 regulatory pathway allows an applicant to submit a new drug application for approval of different formulations,... -
Medical Device Laws and Regulations in Asia – Part 2 – India, Japan, and Korea
This webinar is intended to help you get familiar with medical device laws and regulations in India, Japan, and Korea. The medical devices are currently one of the fastest growing industries. The current knowledge and accurate understanding and adequate... -
Medical Device Laws and Regulations in Asia – 2 Part Web-Series
This 2-part webinar series is intended to help you get familiar with medical device laws and regulations in Asian countries. Module-1 will focus on China and Module-2 will focus on India, Japan, and Korea. The medical devices are currently... -
Medical Device Laws and Regulations in Asia – Part 1 – China
This webinar is intended to help you get familiar with medical device laws and regulations in China. The medical devices are currently one of the fastest growing industries. The current knowledge and accurate understanding and adequate interpretation of global... -
510(k) Update – How to Format Succinct and Comprehensive 510(k)s – 3 Hours Virtual Seminar
This seminar will discuss what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increase submission quality... -
Adequate 510(k) Preparation Could Save Significant Resources – Dos and Don’ts
This seminar is intended to help medical device industry exercise best judgment when preparing for premarket notification for submission to the FDA. This webinar will provide great opportunities to get familiar with FDA policy and guidelines on how... -
What FDA-Regulated Industry Should Know about FDA’s New Policy on GMP Enforcement
There are many things the FDA-regulated industry—including medical device manufacturers and professionals—should know about the FDA’s current inspection policy to adequately implement the good manufacturing practices (GMPs). The consequences of failing to comply with FDA regulations can lead to... -
Developing and Implementing a Global Regulatory Plan and Strategy
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... -
FDA Generic Drug Application and Paragraph IV
The regulatory requirements for generic drugs include, but not limited to, same active ingredients, same dosage form, same route of administration, same strength, and same conditions of use compared to brand name drug product (RLD: reference listed drug). In... -
How to Best Document Clinical Evaluation Report (CER) for CE Mark
To place a medical device on the European market, device firms are required to demonstrate conformity of the device with the relevant essential requirements for the device’s clinical safety and performance for CE marking. In particular, clinical evaluation is... -
Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820
This online seminar (webinar) is intended to help you get familiar with how to establish an internal audit program of the quality management systems (QMS) for medical device manufacturers in preparation for an FDA inspection under 21 CFR Part... -
Complaint Handling – Best Practices
This webinar will provide approaches to setting up an internal complaint handling system that ensures compliance with all GMP requirements. The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during... -
FDA’s New Inspection Policy and Best GMP Practices
In FDA-regulated industry, it is imperative that firms should be well aware of recent policy changes and understand what laws and regulations apply for FDA-regulated products on the US market (e.g., food, drugs, biologics, cosmetics and medical devices including... -
Pain Management and Opioids – FDA Regulations, Generics and Recent Approvals
The United States Food and Drug Administration (FDA) recently expressed deep concerns over the growing epidemic of opioid dependence, overuse and abuse on families and communities. Opioids as prescription drugs are used to reduce chronic pain. Opioids offer both... -
FDA’s New Policy and Risk-Based Strategic Regulatory Updates for Critical Consideration
In FDA-regulated industries, it is imperative that firms should be well aware of and understand the laws and regulations governing FDA-regulated medical products (e.g., food, drugs, biologics, cosmetics, and medical devices including in vitro diagnostics). In particular, it is... -
Good Documentation Practices for Clinical Trials
This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, documentation requirements during clinical trials for both drugs and medical devices. To adequately implement GCPs, there are a set of standard operating procedures (SOPs)... -
GCP/GLP/GMP : Comparison and Understanding of FDA’s 3 Major Regulations
Various firms are subject to various relevant and applicable federal regulations including, but not limited to, Good Laboratory Practice (GLP), Current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP). It is important for the industry to accurately understand... -
Medical Device Laws and Regulations in Asia – China, Hong Kong, Japan and Korea
This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea. The medical devices are currently one of the fastest growing industries. The current knowledge and... -
FDA Inspection Preparation and Readiness – The Top 20 Most Common GMP Deficiencies
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... -
Establishing a Product Stability Testing Program
Each drug product may be unique due to different components, and this is a known fact. The chemical and physical properties of active pharmaceutical Ingredients (APIs), manufacturing methods and procedures, the excipients, formulations, storage conditions, containers and closers and... -
FDA Good Laboratory Practices (GLP) Regulations
Understanding the regulatory requirements set out under good laboratory practice (GLP) regulations is important so that the GLP requirements can be adequately implemented, helping to streamline regulatory processes and to save a significant time and effort during the process.... -
Preparing for FDA BIMO Inspection and Management
Recently, FDA inspection scope and policy have been changed and updated. This webinar is intended to help you get familiar with FDA inspection process, in particular, Bioresearch Monitoring (BIMO) so that firms can better prepare for and manage a... -
FDA Inspection and Medical Device Design Control
According to the recent FDA enforcement trends, inadequate design control is frequently cited in 483s and FDA warning letters. FDA warning letters state “Failure to establish and maintain adequate procedures to control the design of the device in order... -
US FDA Drug Review and Approval Process – Understanding the Latest Regulations
Why You Should Attend : The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs. To introduce a new drug product into the U.S. market, some... -
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Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation
Why Should You Attend This conference is intended to help you get familiar with the FDA-compliant implementation of 21 CFR Part 11 (Part 11) requirements applicable to the FDA-regulated industry (drugs, biologics/biosimilars and medical devices including IVDs). This... -
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GCP/GLP/GMP : Comparison and Understanding of FDA’s 3 Major Regulations
Various firms are subject to various relevant and applicable federal regulations including, but not limited to, Good Laboratory Practice (GLP), Current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP). It is important for the industry to accurately understand... -
Sale!
The FDA 510(k) and Q-Submission: Best Practices
This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss how to put together a... -
Sale!
Medical Device Reporting Requirements for Manufacturers
Medical device manufacturers are subject to medical device reporting for device-related adverse events and malfunctions including record-keeping requirements. This webinar is intended to help you adequately establish and maintain medical device reporting procedures and practices and also to further... -
Sale!
US FDA 510(k) – Latest Guidance, Due Diligence, Preparation, Submission and Clearance
The United States Food and Drug Administration (FDA) recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program. This seminar will provide a great opportunity to get familiar with how to best prepare for a 510(k) for... -
ANDA Approval Process Pursuant to GDUFA
The regulatory requirements for generic drugs include, but not limited to, same active ingredients, same dosage form, same route of administration, same strength, and same conditions of use compared to brand name drug product (RLD: reference listed drug). In... -
Sale!
FDA Inspection Preparation and Readiness – The Top 20 Most Common GMP Deficiencies for Device Manufacturers
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... -
Ensuring an Effective Design of Cleanroom and Facility Validation Compliant with FDA Regulations
When designing a cleanroom, many factors should be considered to adequately implement the requirements for an effective cleanroom design and validation. Otherwise, it can be costly and time-consuming later. This webinar is intended to discuss FDA regulations and the... -
US RAC Exam – How to Prepare Most Effectively
ACCREDITATION: Course “US RAC Exam – How to Prepare Most Effectively” has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion. Having a credential for Regulatory Affairs Certification... -
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The A to Z’s of Microbial Control, Monitoring and Validation of Water Systems
There are eight types of water used in manufacturing drug products. And, it is of paramount importance to design, validate and control water systems used in the manufacture of drugs, biologics and medical devices. This session is intended to... -
Demystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR)
Each manufacturer of any class III or class II device, and the some class I devices shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. This... -
FDA Approval Process for Combination Products
The United States Food and Drug Administration (FDA) reviews, clears or approves regulatory applications for drugs, biologics, medical devices including in vitro diagnostic devices (IVDs) and combination products. It is imperative that firms identify and map evolving regulatory requirements... -
Implementing Adequate CAPA and Design Control Procedures
Device firms, who are intending to bring medical device products into the US market, are subject to quality system regulations. Recent FDA enforcement trends (including 2013) reveal that both design control and Corrective and Preventive Action (CAPA) systems are... -
Good Social Media Practices to Avoid FDA Actions
This seminar is intended to help you adequately implement good social medical practices to avoid FDA enforcement actions for potential misbranding of your drug or device products. The U.S. Food and Drug Administration (FDA) reviewed the firm’s sponsored link... -
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
To achieve and remain compliant with the adequate use of the Excel spreadsheet in FDA-regulated environments, it is critical that laboratory personnel and managers including IT professionals understand and accurately interpret the applicable requirements. This is necessary to ensure... -
Implementing Medical Device Global Adverse Event Reporting Systems
The purpose of this session is to get you acquainted with adverse event reporting requirements and systems in EU, Canada and US. The obligation of Medical Device Manufacturers doesn’t end after obtaining a clearance, approval, registration, listings or certificates.... -
Implementing Best Practices for Global Regulatory Intelligence Programs
Global regulatory agencies including the United States Food and Drug Administration (FDA) review, approve/register or clear regulatory applications for drugs, biologics and/or medical devices including in vitro diagnostic devices (IVDs). It is imperative that firms identify and map evolving... -
Opioid and Pain Management: FDA Perspectives and Requirements
The United States Food and Drug Administration (FDA) recently expressed deep concerns over the growing epidemic of opioid dependence, overuse and abuse on families and communities. Opioids as prescription drugs are used to reduce chronic pain. Opioids offer both... -
ISO 13485:2016 – Understanding The Changes And Requirements
The United States Food and Drug Administration (FDA) FDA has been utilizing information based on inspections conducted by third parties and other regulators in different circumstances pursuant to MDUFMA 2002. Beginning in January, 2014, the FDA has been participating... -
FDA New Requirements for Pyrogen and Endotoxin Testing for Drugs, Biologics and Medical Devices
This presentation is intended to discuss current FDA requirements for pyrogen and endotoxins testing required for drugs, biologics and medical devices for regulatory purposes. In particular, it is intended to discuss FDA’s testing recommendations and acceptance criteria for appropriate... -
Complaint Handling & Medical Device Reporting (MDR)
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... -
Complaint Handling & Medical Device Reporting (MDR)
Description: 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... -
Establishing an FDA-Compliant UDI System
Description: This seminar is intended to help you effectively implement a unique device identification (UDI) system based on the final rules issued and published in federal register. Specifically, new changes in the final rules will be discussed, contributing to... -
FDA 510(k) Requirements, Submission, and Clearance: Best Practices
Description: This presentation will walk you through how to prepare and submit a traditional premarket notification for successful clearance from US FDA. The premarket notification is the most common pathway to market for medical devices including in... -
CE Mark: Content and Format for a Technical File and Design Dossier
Description: This presentation is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices. This presentation is further intended to provide practical, actionable, and sustainable... -
510(k) Preparation, Submission and Clearance: Dos and Don’ts
Description: FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program. This webinar will provide great opportunities to get familiar with how to best prepare for a 510(k) for a successful submission and clearance: in particular,... -
Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs
Description: The US Food and Drug Administration (FDA) states in warning letters “this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities... -
Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820
Description: This webinar is intended to help you adequately develop an internal audit program of a firm’s quality management system (QMS) as required by ISO 13485 or 21 CFR Part 820. 21 CFR 820.22 states “Each manufacturer shall establish... -
Best Practices for Medical Device Recalls
Description: In the United States, medical device firms are subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to establish and maintain... -
Best Practices for 510(k) Drafting and Submission: Dos and Don’ts
Description: From this webinar you will learn best practices for adequately putting your 510(k) together for your successful submission to the FDA, compliant with the FDA’s eCopy and RTA policy. This session will greatly help you streamline your 510(k)... -
Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs
Description: The US Food and Drug Administration (FDA) states in warning letters “this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities... -
510(k) Updates: Trends, New Strategy and FDA Clearance
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission including recent 510(k) trends and updates. This webinar is intended... -
Medical Device Reporting – How to establish and maintain adequate procedures
Description: This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting. Device manufacturers are required to establish and maintain medical device reporting procedures pursuant... -
Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820
Description: This webinar is intended to help you adequately develop an internal audit program of a firm’s quality management system (QMS) as required by ISO 13485 or 21 CFR Part 820. 21 CFR 820.22 states “Each manufacturer shall establish... -
The FDA 510(k): Q-Submission, Preparation and Submission
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss what and how to... -
The FDA 510(k): Q-Submission, Preparation and Submission
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss what and how to... -
Unique Device Identification (UDI) Final Rules Overview
Description: This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules, finally issued on September 24, 2013. This webinar is further intended to help you effectively implement a unique device identification (UDI)... -
510(k) for IVDs
Description: This webinar is intended to demonstrate 510(k) contents and format including 510(k) processesin accordance with FDA’s eCopy and RTA policy, helping you streamline your 510(k) preparation, submission and successful clearance for IVDs, saving days, weeks or months of... -
Good Practices for FDA 510(k): Content and Format
Description: This webinar is intended to demonstrate 510(k) contents and format including 510(k) processes in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) preparation,... -
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
Description: To achieve and remain compliant with the adequate use of the Excel spreadsheet in FDA-regulated environments, it is critical that laboratory personnel and managers including IT professionals understand and accurately interpret the applicable requirements. This is necessary to... -
Good Social Media Practices to Avoid FDA Actions
Description: This seminar is intended to help you adequately implement good social medical practices to avoid FDA enforcement actions for potential misbranding of your drug or device products. The U.S. Food and Drug Administration (FDA) reviewed the firm’s sponsored... -
Preparing for FDA BIMO Inspection and Management
Description: Recently, FDA inspection scope and policy have been changed and updated. This webinar is intended to help you get familiar with FDA inspection process, in particular, Bioresearch Monitoring (BIMO) so that firms can better prepare for and manage... -
FDA Good Laboratory Practice (GLP)
Description: Understanding the regulatory requirements set out under good laboratory practice (GLP) regulations is important so that the GLP requirements can be adequately implemented, helping to streamline regulatory processes and to save a significant time and effort during the... -
Best Practices for Communicating and Interacting with FDA Reviewers
Description: At the US Food and Drug Administration (FDA), there are various types of professionals with differing background in diverse areas of laws, medicines, physics, biology, chemistry, engineering, etc. To effectively navigate the regulatory process, it becomes important to... -
Good Clinical Practices (GCP)
Description: This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements during clinical trials for both drugs and medical devices. To adequately implement GCPs, there are a set of standard operating procedures (SOPs)... -
Big Data in FDA-Regulated Industry: Best Practices for Systematic Use
Description: In recent years, big data and information is available in public domain. Adequate use of such big data in FDA-regulated industry has become critically important to exercise best practices. In this presentation, the speaker will provide a great... -
Annual Reports for Approved PMAs
Description: This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for level of detail the applicant should provide in the PMA annual report. Also addressed are... -
Good Documentation Practices for Clinical Trials
Description: This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, documentation requirements during clinical trials for both drugs and medical devices. To adequately implement GCPs, there are a set of standard operating procedures... -
Good Practices in Preparing for an FDA Inspection Preparation with Awareness: Do’s and Don’ts
Description: This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection in an actionable, sustainable manner with improved awareness. If a firm is subject to FDA regulations, they should be... -
Big Data in FDA-Regulated Industry: Best Practices for Systematic Use
Description: In recent years, big data and information is available in public domain. Adequate use of such big data in FDA-regulated industry has become critically important to exercise best practices. In this presentation, the speaker will provide a great... -
Good Clinical Practices (GCP)
Description: This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements during clinical trials for both drugs and medical devices. To adequately implement GCPs, there are a set of standard operating procedures (SOPs)... -
Best Practices for Communicating and Interacting with FDA Reviewers
Description: At the US Food and Drug Administration (FDA), there are various types of professionals with differing background in diverse areas of laws, medicines, physics, biology, chemistry, engineering, etc. To effectively navigate the regulatory process, it becomes important to... -
FDA Good Laboratory Practice (GLP)
Description: Understanding the regulatory requirements set out under good laboratory practice (GLP) regulations is important so that the GLP requirements can be adequately implemented, helping to streamline regulatory processes and to save a significant time and effort during the... -
Preparing for FDA BIMO Inspection and Management
Description: Recently, FDA inspection scope and policy have been changed and updated. This webinar is intended to help you get familiar with FDA inspection process, in particular, Bioresearch Monitoring (BIMO) so that firms can better prepare for and manage... -
Good Social Media Practices to Avoid FDA Actions
Description: This seminar is intended to help you adequately implement good social medical practices to avoid FDA enforcement actions for potential misbranding of your drug or device products. The U.S. Food and Drug Administration (FDA) reviewed the firm’s sponsored... -
Validation and Use of Excel Spreadsheets in FDA Regulated Environments
Description: To achieve and remain compliant with the adequate use of the Excel spreadsheet in FDA-regulated environments, it is critical that laboratory personnel and managers including IT professionals understand and accurately interpret the applicable requirements. This is necessary to... -
Good Practices for FDA 510(k): Content and Format
Description: This webinar is intended to demonstrate 510(k) contents and format including 510(k) processes in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) preparation,... -
510(k) for IVDs
Description: This webinar is intended to demonstrate 510(k) contents and format including 510(k) processesin accordance with FDA’s eCopy and RTA policy, helping you streamline your 510(k) preparation, submission and successful clearance for IVDs, saving days, weeks or months of... -
Unique Device Identification (UDI) Final Rules Overview
Description: This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules, finally issued on September 24, 2013. This webinar is further intended to help you effectively implement a unique device identification (UDI)... -
The FDA 510(k): Q-Submission, Preparation and Submission
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss what and how to... -
Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820
Description: This webinar is intended to help you adequately develop an internal audit program of a firm’s quality management system (QMS) as required by ISO 13485 or 21 CFR Part 820. 21 CFR 820.22 states “Each manufacturer shall establish... -
Medical Device Reporting – How to establish and maintain adequate procedures
Description: This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting. Device manufacturers are required to establish and maintain medical device reporting procedures pursuant... -
510(k) Updates: Trends, New Strategy and FDA Clearance
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission including recent 510(k) trends and updates. This webinar is intended... -
The FDA 510(k): Q-Submission, Preparation and Submission
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss what and how to... -
Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs
Description: The US Food and Drug Administration (FDA) states in warning letters “this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities... -
Best Practices for 510(k) Drafting and Submission: Dos and Don’ts
From this webinar you will learn best practices for adequately putting your 510(k) together for your successful submission to the FDA, compliant with the FDA’s eCopy and RTA policy. This session will greatly help you streamline your 510(k) preparation... -
Best Practices for Medical Device Recalls
Description: In the United States, medical device firms are subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to establish and maintain... -
The FDA 510(k) and Q-Submission: Best Practices
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss how to put together... -
Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820
Description: This webinar is intended to help you adequately develop an internal audit program of a firm’s quality management system (QMS) as required by ISO 13485 or 21 CFR Part 820. 21 CFR 820.22 states “Each manufacturer shall establish... -
510(k) Preparation, Submission and Clearance: Dos and Don’ts
Description: FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program. This webinar will provide great opportunities to get familiar with how to best prepare for a 510(k) for a successful submission and clearance: in particular,... -
CE Mark: Content and Format for a Technical File and Design Dossier
Description: This presentation is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices. This presentation is further intended to provide practical, actionable, and sustainable... -
FDA 510(k) Requirements, Submission, and Clearance: Best Practices
Description: This presentation will walk you through how to prepare and submit a traditional premarket notification for successful clearance from US FDA. The premarket notification is the most common pathway to market for medical devices including in... -
Establishing an FDA-Compliant UDI System
Description: This seminar is intended to help you effectively implement a unique device identification (UDI) system based on the final rules issued and published in federal register. Specifically, new changes in the final rules will be discussed, contributing to... -
Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs
Description: The US Food and Drug Administration (FDA) states in warning letters “this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities... -
Complaint Handling & Medical Device Reporting (MDR)
Description: 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... -
The FDA 510(k) and Q-Submission: Best Practices
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss how to put together... -
Annual Reports for Approved PMAs
Description: This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for level of detail the applicant should provide in the PMA annual report. Also addressed are... -
Good Documentation Practices for Clinical Trials
Description: This webinar is intended to help you adequately implement Good Clinical Practices (GCP): in particular, documentation requirements during clinical trials for both drugs and medical devices. To adequately implement GCPs, there are a set of standard operating procedures... -
Good Practices in Preparing for an FDA Inspection Preparation with Awareness: Do’s and Don’ts
Description: This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection in an actionable, sustainable manner with improved awareness. If a firm is subject to FDA regulations, they should be...
