
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.

Zero-Injury Workplace Culture vs. Safety Culture
Joe Keenan
60 Min
Product Id: 704986
Creating a safety culture in the workplace takes time, patience, and is often a multi-year process. This training program will examine how organizations need to transition from the existing zero injury workplace culture to a more safety oriented culture. In the process, it will examine the pros and cons behind each process and also offer best practices to determine whether you are doing it right.

Risk Management for Medical Devices per ISO 14971 2019
Jose Mora
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.

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
Frank Stein
3 Hrs
Product Id: 706565
This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.

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.

TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties
Miles Hutchinson
90 Min
Product Id: 703028
Learn the best practices for eliminating 1099 error notices from the IRS. Discover the power of the TIN Matching system. Discover the smoothest way to register to use the two step verification process introduced 12/10/17. Learn how to handle the CP-2100 notices from Uncle Sam and avoid the fines & penalties for failure to timely comply with the B-Notice requirements. Understand the difference between and 1st and 2nd B-Notice and the related differences in required vendor responses. Be sure you institute and stop Backup Withholding when required. Join us for a content-rich 2-hours and you will gain the tools to make you the most effective information return manager your company has ever seen.

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.

Estimating Reliability Performance with Accelerated Life Tests
Steven Wachs
90 Min
Product Id: 702095
This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.

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.

Conducting Your 2023 Annual ACH Rules Compliance Audit - a Step-by-Step Guide
Donna K Olheiser
90 Min
Product Id: 705082
This session will cover “step-by-step” the audit process and requirements for each participant conducting an annual ACH audit, to help ensure their compliance with the Nacha Operating Rules.
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).

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
Kelly Eisenhardt
60 Min
Product Id: 703871
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.

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.

Storm Water Pollution Prevention Plans (SWPPP)
Joe Keenan
90 Min
Product Id: 705510
This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.

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.

Terminally Sterilized Pharmaceutical Products – Parametric Release ( New USP<1222>, November 2019) and its Relationship to the new British Terminal Steriliation Methodology (March 2019)
Barry A Friedman
90 Min
Product Id: 706908
This General Information Chapter (USP<1222>) will first cover the general issues related to parametric release, regardless of the modes of sterilization, and then discuss some specific modes of sterilization. It will also include information on USP<55> Biological Indicators as well as EU “Guideline on the Sterilization of Medicinal Products…” (March 2019). The webinar will discuss why it provides more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.

The 510(k), IDE, Q-Sub, De Novo, and PMA Submission and Approval Process
John E Lincoln
90 Min
Product Id: 706915
The U.S FDA requires that 21 basic elements be addressed in the traditional 510(k) submission. This can serve as a model for other submissions.

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.