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 / Jun / 2024 - Monday

* Per Attendee $299

 

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. 

19 / Jun / 2024 - Wednesday

* Per Attendee $199

 

US FDA Requirements for Medical Products Labeling / UDI

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706969

The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.

15 / Jul / 2024 - Monday

* Per Attendee $199

 

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.

15 / Jul / 2024 - Monday

* Per Attendee $199

 

The 510(k) Mod Program, Breakthrough Technologies, and STeP

webinar-speaker   John E Lincoln

webinar-time   90 min

Product Id: 706976

What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.

7 / Aug / 2024 - Wednesday

* Per Attendee $199

 

Technical Writing for Medical Devices

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 706379

This technical writing training program will offer attendees an understanding of how the reporting process supports products in the medical device industry. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, 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.

9 / Aug / 2024 - Friday

* Per Attendee $249

 

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 704315

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

Recording Available

 

Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences

webinar-speaker   Charles H Paul

webinar-time   90 Min

Product Id: 706939

The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.

Recording Available

 

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

 

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

webinar-speaker   Frank Stein

webinar-time   90 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.

Recording Available

* Per Attendee $299

 

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

 

Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706951

The California Consumer Privacy Act (CCPA) was enacted into law on June 28, 2018 and became effective on January 1, 2020. CCPA provided a variety of consumer privacy rights and the obligations of business related to their storage and sale of personal information.

Voters in California voted to approve Proposition 24, a ballot measure, on November 3, 2020, which created the California Privacy Rights Act (CPRA). The purpose of CPRA was to modify and expand the requirements of the CCPA, thus amending the original act. CPRA is commonly referred to as “CCPA 2.0.”

CPRA ends the ban on providing the CCPA’s consumer privacy rights to a company’s employees. Under CPRA, all employers must respond to requests from employees to access or correct their personal data. Enforcement of CPRA will become effective in July 2023, enabling companies six months to ramp up their efforts to comply with it.

CPRA also extends new protections to consumers residing in California. Those organizations doing business with these consumers are subject, based on defined threshold of operation, to the compliance requirements.

Recording Available

* Per Attendee $249

 

How to Achieve Validation Requirements for a Clean Room Manufacturing Environment

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706947

Both the U.S. FDA and EU's MDR expect documented risk-based clean room manufacturing environment per ISO 14644-series, ISO 14698-series (and the old FED-STD 209E).

Recording Available

* Per Attendee $249

 

US FDA Medical Device QSR (21 CFR 820) / Quality Management System - current and proposed major changes

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706950

The US FDA/CDRH is proposing to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) by converging its requirements with requirements used by many other regulatory authorities. ISO 13485, into a new device Quality Management System Regulation (QMSR).

Recording Available

* Per Attendee $249

 

Cybersecurity - The Latest US FDA Requirements

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706949

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

 

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