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Implementing Human Factors in Manufacturing
Ginette M Collazo
90 Min
Product Id: 706999
This course on Implementing Human Factors in Manufacturing provides a comprehensive overview of how to integrate human factors principles into manufacturing processes to reduce errors, improve safety and quality, and enhance operational efficiency. Participants will learn about the types and causes of human errors, ergonomic design principles, human-machine interface optimization, and effective strategies for fostering a culture of safety, quality, and continuous improvement. Through interactive workshops, case studies, and practical applications, attendees will gain the tools needed to conduct human factors assessments, design effective training programs, and develop actionable plans for sustainable improvement in their organizations.
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How to Prepare a Standard Operating Procedure (SOP)?
Dr. Afsaneh Motamed Khorasani
60 Min
Product Id: 705131
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
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Understanding Financial Risk
Stanley Epstein
90 Min
Product Id: 707000
Understanding financial risk is crucial for anyone involved in managing assets or investments or running a business. Financial risk encompasses a wide array of threats that can significantly impact an individual's or organization's financial health. By exploring financial risk dynamics, one can better grasp how various factors such as market fluctuations, liquidity constraints, credit defaults, business disruptions, and investment uncertainties can lead to potential financial losses.
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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
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Calibration and Validation of Equipment
John E Lincoln
90 Min
Product Id: 707002
Both the U.S. FDA and EU's MDR expect documented calibration and risk-based V&V under U.S. FDA cGMPs, the EU MDR, ICH Q9 and ISO 14971
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Function, Preparation and Execution of Job Aids in the Pharmaceutical Industry
Michael Esposito
90 Min
Product Id: 707001
Learn how to effectively develop, prepare, and execute job aids in the pharmaceutical industry. This webinar covers the key characteristics of job aids, their purpose, use in training, and their role in qualifying individuals for independent tasks. Understand the importance of document hierarchies, skill checks, and how to train others to deliver job aid training.
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Trial Master File and Clinical Data Management Regulated by FDA
Carolyn Troiano
60 Min
Product Id: 705360
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.
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).
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EU Medical Device Regulation 2017/745
Juan M Campos
90 Min
Product Id: 707003
Compliance with European Medical Device Regulation 2017/745 (MDR) is mandatory for all medical devices placed in the market in any member state of the European Union. It is of strategic importance for any medical device manufacturer to understand and effectively apply the MDR requirements to access this critical market.
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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.
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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.
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Conducting Effective Quality Audits: Beyond Audit Checklists
Michael Ferrante
60 Min
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.
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FDA Bioresearch Monitoring Inspection Program 2024
David L Chesney
90 Min
Product Id: 706994
This webinar presents a survey of the FDA’s Bioresearch Monitoring Program, a series of FDA inspection programs covering regulatory inspections by the FDA of clinical trial sites, sponsors and Clinical Research Organizations, nonclinical testing laboratories, Institutional Review Boards (IRBs) and post marketing adverse event reporting requirements.
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UK RoHS and REACH: Post Brexit Obligations and Changes in 2024
Kelly Eisenhardt
60 Min
Product Id: 706679
This 1-hour webinar will provide high-level overview of the UK RoHS and REACH obligations effective January 1, 2024 due to Brexit. Key developments and dates will be discussed with an emphasis on the new regulations and systems implemented by the UK.
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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
Roger Cowan
60 Min
Product Id: 703727
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
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Toxic Substance Control Act (TSCA) Awareness Training 101
Joe Keenan
90 Min
Product Id: 706205
Attend this training to understand all the requirements of the Toxic Substance Control Act (TSCA), its revisions, and how to develop a written plan, TSCA Training Plan. Get answers to your TSCA questions.
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Precision Tools for Error Reduction: Strategies and Implementation Techniques
Ginette M Collazo
90 Min
Product Id: 704364
This training program will analyze the factors and causes behind human errors. It will define the process to manage human error deviations and participants will learn about human error measurement. The program will also discuss tools for measurement and Key Performance Indicators (KPIs).
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How to Prepare an Effective Audit Manual for an Internal Audit Department
Marna Steuart
75 Min
Product Id: 703684
This webinar will instruct attendees on how to develop an internal audit manual and offer start to finish instructions and templates on how to perform different types of audits given the project description. Audit fieldwork, audit reporting and follow-up, work-paper filing, and project closure are some of the other areas the webinar will cover.
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US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW - MDSAP & EU ISO 13485 approach
Juan M Campos
60 Min
Product Id: 706301
This webinar will discuss the main regulatory regimes for medical devices in US, Canada, Brazil, Japan and Australia, how they differ from EU CE mark regulations and how to address compliance though a Medical Device Single Audit Program (MDSAP) and ISO 13486:2016 approach
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Nacha Updates in the ACH Network (Operations Bulletins-RFC and RFI Details)
Donna K Olheiser
90 min
Product Id: 707007
As payments continue to evolve, so does the ACH Network. In an effort to continually update the Nacha Operating Rules, Nacha had put out a RFC (Request for Comment) on adding a fourth window of opportunity for SDA (Same Day ACH) payments to allow more functionality with Same Day payments in all time zones.