P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3
John E Lincoln
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.
The eSTAR Submission Program for 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions
John E Lincoln
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.
US FDA Requirements for Medical Products Labeling / UDI
John E Lincoln
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.
US FDA's Cybersecurity and NIST Framework Requirementsfor Networks
John E Lincoln
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.
Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences
Charles H Paul
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.
Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3
John E Lincoln
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.
Deconstructing EU MDR with Principles of Lean Documents and Lean Configuration
Jose Mora
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.
The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs
John E Lincoln
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).
Drug Labeling and Packaging: Meeting Regulatory Requirements
Charles H Paul
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.
FDA's New Software Validation Requirements
John E Lincoln
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.
Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)
Carolyn Troiano
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.
How to Achieve Validation Requirements for a Clean Room Manufacturing Environment
John E Lincoln
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).
US FDA Medical Device QSR (21 CFR 820) / Quality Management System - current and proposed major changes
John E Lincoln
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).
Validation Statistics for Non-Statisticians
Alan M Golden
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.
Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration
Jose Mora
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.
US FDA's AI Framework for Medical Devices
John E Lincoln
90 Min
Product Id: 706934
The ability of artificial intelligence / machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices. The FDA recognizes AI's advantages and dangers and has started to outline its expectations of industry and device design, programming, unique validation issues, documentation and submissions.
CGMP Manufacturing Methods: P&PC and SPC
John E Lincoln
90 Min
Product Id: 706929
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.
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Kelly Thomas
90 Min
Product Id: 706927
This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources, and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, Data Trending, Microbiological processes/methodology, Cleanroom cleaning/disinfection.
Test Method / Design Verification and Validation
John E Lincoln
Product Id: 706920
Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design Verification and Validation under U.S. FDA cGMP, EU MRD and ISO 14971
Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning the Agile Methodology to the GAMP®5 "V" Model and System Development Life Cycle (SDLC) Methodology
Carolyn Troiano
120 Min
Product Id: 706921
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower than anticipated investment in automation and digital technologies, which could greatly improve quality and process control. A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) waterfall approach. This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation driven approaches.
This is where FDA determined that “WHAT” is required can be done (the “HOW”) in different ways and does not have to be according to the “checklist” mindset of most CSV work, where you create documents without specifically addressing the risk of potential failure of each requirement.
GAMP®5 supports the use of incremental, iterative, and evolutionary approaches including agile, for development of custom applications. Keys to success include a robust Quality Management System and well trained and highly disciplined teams following well-defined processes supported by tools and automation.