
Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data
Carolyn Troiano
90 Min
Product Id: 706925
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data. Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

Sample Size Determination for Design Validation Activities
Steven Wachs
90 Min
Product Id: 705852
Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
John E Lincoln
90 Min
Product Id: 700149
In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.

Technical Writing - Medical Devices - Writing Effective 510K, PMA, and De Novo Submissions
Charles H Paul
180 Min
Product Id: 706931
In a rapidly evolving medical landscape, the significance of meticulous and effective technical writing cannot be overstated. Join us for a enlightening 3-hour webinar, "Technical Writing for Medical Devices: Writing Effective 510(k), PMA, and De Novo Submissions," where we will delve into the intricacies of crafting comprehensive and persuasive regulatory submissions. From the foundational understanding of regulatory pathways to the fine art of presenting clinical data, this webinar will equip you with the tools and knowledge necessary to excel in this critical aspect of the medical device industry.

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
Carolyn Troiano
90 Min
Product Id: 706930
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.

Analytical Method Validation and Transfer
Kelly Thomas
90 Min
Product Id: 706186
This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.
The 6 Most Common Problems in FDA Software Validation and Verification
David Nettleton
120 Min
Product Id: 705582
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)
Carolyn Troiano
90 Min
Product Id: 706932
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

Understanding FDA and Health Canada
Ricki Chase
90 Min
Product Id: 706933
This webinar will provide an overview of FDA and Health Canada, their organizational structure, regulatory and compliance oversight, agency interactions and implications for your organization and your regulatory and compliance obligations.

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.

The GCPs: How to Implement for Compliant Clinical Trials
John E Lincoln
90 Min
Product Id: 706935
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible.

Aseptic Processing Overview and Validation
Kelly Thomas
90 Min
Product Id: 706212
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Quality Assurance and Good Manufacturing Practices (GMP) in Drug Production
Charles H Paul
90 Min
Product Id: 706936
Quality Assurance (QA) and Good Manufacturing Practices (GMP) play a critical role in ensuring the safety, efficacy, and quality of drugs during their production. In the pharmaceutical industry, QA refers to the systematic processes and procedures implemented to guarantee that drugs meet the established standards and regulatory requirements. GMP, on the other hand, encompasses a set of guidelines and regulations that govern the manufacturing, testing, and quality control of pharmaceutical products.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
90 Min
Product Id: 701687
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

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

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.

Design Control Requirements / Documents Under 21 CFR 820.30 and 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.

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.

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

Impact Assessment for Change Control
Alan M Golden
60 Min
Product Id: 706337
Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.