
AI, ML & FDA Compliance for Computer Systems & Data
Carolyn Troiano
90 Mins
Product Id: 707021
During the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.

US FDA's AI Framework for Medical Devices
John E Lincoln
90 Mins
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.

Mapping and Review of Pharmaceutical Manufacturing and Packaging Workflows
Michael Esposito
90 Mins
Product Id: 707023
Mapping and evaluating all the steps in a pharmaceutical manufacturing and packaging workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

Business Process Mapping (BPM) – Streamlining Management of Data/Records for Clinical Trial from Variety of Stakeholders/Systems
Carolyn Troiano
90 Mins
Product Id: 707024
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF) or electronic trial master file (eTMF).

How to Achieve Validation Requirements for a Clean Room Manufacturing Environment
John E Lincoln
90 Mins
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).

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 Mins
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.

Conducting Effective Quality Audits: Beyond Audit Checklists
Michael Ferrante
60 Mins
Product Id: 703539
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.

Analytical Method Validation and Transfer
Kelly Thomas
90 Mins
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.

Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data
Carolyn Troiano
90 Mins
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.

FDA's New Software Validation Requirements
John E Lincoln
90 Mins
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.

Mapping and Review of Pharmaceutical Warehousing and Distribution Workflows
Michael Esposito
90 Mins
Product Id: 707026
Mapping and evaluating all the steps in a pharmaceutical warehousing and distribution workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures
Carolyn Troiano
90 Mins
Product Id: 707014
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Ethylene Oxide and Gamma Radiation Sterilization Validations
John E Lincoln
90 Mins
Product Id: 707018
Gamma and EO Sterilization verification and validations under the U.S. FDA and EU's EMA / MDR requirements

US Market Access & Reimbursement : Medical Devices
Robert J Russell
60 Min
Product Id: 706989
This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device

Analytical Method Development, and Method Transfer
John E Lincoln
90 mins
Product Id: 707009
The U.S. FDA and EU's MDR require specific steps to be fulfilled to develop and/or transfer analytical methods to maintain accuracy.

Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment
Gerry O Dell
90 Min
Product Id: 701929
This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98.

You have a BI Positive or Product Sterility Positive - Now What?
Gerry O Dell
75 Min
Product Id: 703288
This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered.

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Joy McElroy
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.

Installation and Qualification of the Packaging Lines
John E Lincoln
90 Min
Product Id: 706996
Both the U.S. FDA and EU's MDR expect documented risk-based IQ, OQ, an PQs of medical packaging lines under U.S. FDA cGMP, EU MRD, ICH Q7 and Q9 and ISO 14971

Preapproval Inspection and Submission to the FDA
John E Lincoln
90 Min
Product Id: 706998
This webinar is intended to provide guidance regarding the FDA program to approve an NDA or an ANDA or PMA only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug or Class III device are found adequate to ensure and preserve the drug's identity, strength, quality, and purity, or the device's safety and performance.