WEBINARS

 

GXP Medical Devices Training

Learn the best practices through expert training programs to streamline the compliance processes and meet the GXP Medical Devices demands. This section constitutes of GXP Medical Devices training, standards, best practices, online store and news related to Medical Devices regulated industries

Analytical Method Development, and Method Transfer

webinar-speaker   John E Lincoln

webinar-time   90 mins

Product Id: 707009

The U.S. FDA and EU's MDR require specific steps to be fulfilled to develop and/or transfer analytical methods to maintain accuracy.

6 / May / 2025 - Tuesday

* Per Attendee $199

 

US Market Access & Reimbursement : Medical Devices

webinar-speaker   Robert J Russell

webinar-time   60 Min

Product Id: 706989

This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device

9 / May / 2025 - Friday

* Per Attendee $199

 

Performing Effective Management Review of the Quality System

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 704933

This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

19 / May / 2025 - Monday

* Per Attendee $199

 

FDA Regulations for Tobacco & Tobacco-Related Products – Computer System Validation (CSV), 21 CFR Part 11 (electronic records/signatures), Data Integrity & Compliance

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 707010

This webinar will focus on the computer systems and data that are regulated by FDA. These systems will require validation and the data must be created and maintained with integrity. We’ll cover what is required for Computer System Validation (CSV) and we’ll discuss the new draft guidance from FDA on Computer Software Assurance (CSA). We’ll also cover 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures. Finally, we’ll discuss the “ALCOA+” requirements for data integrity.

23 / May / 2025 - Friday

* Per Attendee $199

 

Analytical Methods, Process, Equipment, Cleaning, and Sterilization Validations

webinar-speaker   John E Lincoln

webinar-time   90 mins

Product Id: 707011

Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al

11 / Jun / 2025 - Wednesday

* Per Attendee $199

 

ISO 13485:2016 Quality Systems

webinar-speaker   Juan M Campos

webinar-time   90 Mins

Product Id: 707013

Compliance with international standard ISO 13485:2016 is mandatory for all medical devices placed in most of the main markets word wide. It is of strategic importance for any medical device manufacturer to understand and effectively apply the ISO 13485:2016 requirements to access these critical markets.

12 / Jun / 2025 - Thursday

* Per Attendee $199

 

21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures

webinar-speaker   Carolyn Troiano

webinar-time   90 Mins

Product Id: 707014

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

23 / Jun / 2025 - Monday

* Per Attendee $199

 

Drug, Device and Combination Product Development

webinar-speaker   John E Lincoln

webinar-time   90 Mins

Product Id: 707015

This webinar provides a basic overview of the stages of development and V&V of the basic categories of medical products, from R&D through Production, and the US FDA regulatory and documentation requirements at the various stages.

24 / Jun / 2025 - Tuesday

* Per Attendee $199

 

Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

webinar-speaker   Gerry O Dell

webinar-time   90 Min

Product Id: 701929

This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98.

Recording Available

* Per Attendee $249

 

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704531

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

Recording Available

* Per Attendee $249

 

Installation and Qualification of the Packaging Lines

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706996

Both the U.S. FDA and EU's MDR expect documented risk-based IQ, OQ, an PQs of medical packaging lines under U.S. FDA cGMP, EU MRD, ICH Q7 and Q9 and ISO 14971

Recording Available

* Per Attendee $249

 

Preapproval Inspection and Submission to the FDA

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706998

This webinar is intended to provide guidance regarding the FDA program to approve an NDA or an ANDA or PMA only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug or Class III device are found adequate to ensure and preserve the drug's identity, strength, quality, and purity, or the device's safety and performance.

Recording Available

* Per Attendee $249

 

US FDA's Cybersecurity and NIST Framework Requirementsfor Networks

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706971

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry. 

Recording Available

* Per Attendee $249

 

The eSTAR Submission Program for 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706968

The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.

Recording Available

* Per Attendee $249

 

P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706963

This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.

Recording Available

* Per Attendee $249

 

Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706923

Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.

Recording Available

* Per Attendee $249

 

Deconstructing EU MDR with Principles of Lean Documents and Lean Configuration

webinar-speaker   Jose Mora

webinar-time   120 Min

Product Id: 706959

The EU MDR is a comprehensive and complex regulation that combines all aspects of placing certain types of medical devices on the EU market into one regulation. It addresses the obligations of economic operators in this role, and provides for extensive databases, clinical requirements, classifications, conformity, and many defined relationships between agencies, member states, and other directives and regulations.

This webinar deconstructs the many parts of this regulation into the elements of lean documents and lean configuration, providing an opportunity to apply these principles as a way to create and maintain flexibility as this and new harmonized standards and regulations emerge.

Recording Available

* Per Attendee $279

 

The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706961

The US FDA, after years of discussing the harmonization of 21 CFR 820, Device CGMPs (QSR), to the ISO 13485, Device QMS, has finally published their QMSR to replace the previous QSR. On February 02, 2024, they published the final rule in the US Federal Register that revises 21 CFR 820 to include ISO 13485:2016 by reference, called the Quality Management System Regulation (QMSR).

Recording Available

* Per Attendee $249

 

Drug Labeling and Packaging: Meeting Regulatory Requirements

webinar-speaker   Charles H Paul

webinar-time   60 Min

Product Id: 706953

The webinar, titled "Drug Labeling and Packaging: Meeting Regulatory Requirements," is a comprehensive exploration of the critical nexus between pharmaceutical labeling, packaging, and regulatory mandates. Over the course of 60 minutes, this session will provide participants with a thorough understanding of the pivotal role that accurate and compliant drug labeling and packaging play in ensuring patient safety and meeting global regulatory standards.

Recording Available

* Per Attendee $249

 

FDA's New Software Validation Requirements

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706952

CGMP companies must develop / implement formal software V&V for medical product under IEC 62304 and a key US FDA Guidance Document.

Recording Available

* Per Attendee $249

 

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