Supplier Management with the new Medical Device Regulation EU MDR 745/2017

webinar-speaker   Frank Stein

webinar-time   60 Min

Product Id: 706068

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.

13 / Jan / 2025 - Monday

* Per Attendee $199

 

Troubleshooting Ethylene Oxide (EO) Processes

webinar-speaker   Gerry O Dell

webinar-time   75 min

Product Id: 701679

Not every parameter in the EO sterilization process in critical for the determination of the product’s sterility assurance level (SAL). This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. These actions can be as simple as a rationale for release to as complicated as the need for the qualification of a new sterilization process. How to decide the actions to take will be addressed along with the reasons behind the decisions so that an accurate and complete justification of your decision can be made for both management and regulatory agencies. The rationales for both conventional and parametric release will be addressed.

13 / Jan / 2025 - Monday

* Per Attendee $199

 

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.

14 / Jan / 2025 - Tuesday

* Per Attendee $199

 

Implementing Human Factors in Manufacturing

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706999

This course on Implementing Human Factors in Manufacturing provides a comprehensive overview of how to integrate human factors principles into manufacturing processes to reduce errors, improve safety and quality, and enhance operational efficiency. Participants will learn about the types and causes of human errors, ergonomic design principles, human-machine interface optimization, and effective strategies for fostering a culture of safety, quality, and continuous improvement. Through interactive workshops, case studies, and practical applications, attendees will gain the tools needed to conduct human factors assessments, design effective training programs, and develop actionable plans for sustainable improvement in their organizations.

28 / Jan / 2025 - Tuesday

* Per Attendee $199

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

28 / Jan / 2025 - Tuesday

* Per Attendee $199

 

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

31 / Jan / 2025 - Friday

* Per Attendee $199

 

Calibration and Validation of Equipment

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 707002

Both the U.S. FDA and EU's MDR expect documented calibration and risk-based V&V under U.S. FDA cGMPs, the EU MDR, ICH Q9 and ISO 14971

4 / Feb / 2025 - Tuesday

* Per Attendee $199

 

EU Medical Device Regulation 2017/745

webinar-speaker   Juan M Campos

webinar-time   90 Min

Product Id: 707003

Compliance with European Medical Device Regulation 2017/745 (MDR) is mandatory for all medical devices placed in the market in any member state of the European Union. It is of strategic importance for any medical device manufacturer to understand and effectively apply the MDR requirements to access this critical market.

6 / Feb / 2025 - Thursday

* 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.

10 / Feb / 2025 - Monday

* Per Attendee $199

 

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.

10 / Feb / 2025 - Monday

* Per Attendee $229

 

Conducting Effective Quality Audits: Beyond Audit Checklists

webinar-speaker   Michael Ferrante

webinar-time   60 Min

Product Id: 703539

This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.

11 / Feb / 2025 - Tuesday

* Per Attendee $199

 

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

webinar-speaker   Steven Wachs

webinar-time   75 Min

Product Id: 705020

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

Recording Available

* Per Attendee $249

 

Gaining and Re-establishing Control of Your Cleanroom

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705317

This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.

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

 

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