Integrating Production Equipment, Processes, Systems and Procedures

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706956

Both the U.S. FDA and EU's MDR expect documented risk-based equipment, process,systems and procedures development, integration and maintenance.

5 / Mar / 2024 - Tuesday

* Per Attendee $199

 

Medical Products Manufacturing Operations, Regulations and Controls

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706958

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.

15 / Mar / 2024 - Friday

* Per Attendee $199

 

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706930

We will discuss the importance of complying with FDA requirements for validation of systems using technologies that have been emerging for the past couple of decades. While FDA is planning to overhaul their own infrastructure to gain efficiencies, they are also encouraging industry to take advantage of newer technology and systems. These include cloud-based systems, Software-as-a-Service (SaaS), artificial intelligence, and others.

We’ll talk about taking a risk-based approach to validation, and how to implement newer capabilities such as electronic records and electronic signatures. We’ll also cover the importance of meeting data integrity compliance.

18 / Mar / 2024 - Monday

* Per Attendee $199

 

Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706165

Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

18 / Mar / 2024 - Monday

* Per Attendee $199

 

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.

20 / Mar / 2024 - Wednesday

* Per Attendee $229

 

Lean Manufacturing For U.S. FDA-Regulated Industries

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706960

New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.

27 / Mar / 2024 - Wednesday

* Per Attendee $199

 

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).

3 / Apr / 2024 - Wednesday

* Per Attendee $199

 

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

 

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

 

Validation Statistics for Non-Statisticians

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706944

In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the concept of process capability and using process capability to set acceptance criteria for validation.

Recording Available

* Per Attendee $249

 

Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration

webinar-speaker   Jose Mora

webinar-time   90 Min

Product Id: 706942

Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration. Does your DHF remediation process resemble the very mess that it is trying to resolve?
The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards. While it is retrospective in nature, it is the end result of a process that begins with planning and ends with Design Transfer and has the Device Master Record (DMR) as a deliverable.

Recording Available

* Per Attendee $249

 

Medical Device Cybersecurity Risk Management Training

webinar-speaker   Frank Stein

webinar-time   3 Hrs

Product Id: 706560

This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.

Recording Available

* Per Attendee $399

 

Risk Management for Medical Devices per ISO 14971 2019

webinar-speaker   Jose Mora

webinar-time   60 Min

Product Id: 706924

ISO 14971:2019 has introduced significant changes including benefit, reasonably foreseeable misuse and state of the art, as well as the management of risks associated with medical devices. It is important to be aware of these changes as technology continues to emerge.

Recording Available

* Per Attendee $249

 

How to Comply with FDA Regulations for Tobacco-Related Products: Computer System Validation, 21 CFR Part 11, & Data Integrity

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706937

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

Recording Available

* Per Attendee $249

 

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