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Documentation and Policy Management Training - Live Webinars, Recordings & CDs

Learn the standards for documentation and management, maintain consistency with common law, regulatory requirements, ethical and current best practice requirements. On this page, browse a broad range of courses specially designed for you.

Recorded/CD

FDA's Proposed Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List

Speaker: David Dills
Product ID: 701907
Duration: 76 Min

Learn about the proposed Device Establishment Registration and Listing rule and how to meet the FDA requirements and expectations.

CD/Recorded
$500

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Recorded/CD

Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections

Speaker: Glen Feye
Product ID: 700375
Duration: 63 Mins

This SOP best practices webinar will show how to create “state of the art” SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.

CD/Recorded
$149

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Recorded/CD

Managing Corporate Risks with ISO 31000

Speaker: Kelly Eisenhardt
Product ID: 705083
Duration: 60 Min

ISO 31000 is a standard developed by the International Organization for Standardization (ISO) which provides a basic guideline and principles for the application of risk management. Companies that use risk management processes vary across industries in scope and magnitude and address a wide variety of challenges. This training program will offer an in depth look into the key components of the ISO 31000 guideline and best practices to implement and support a corporate risk management strategy or program.

CD/Recorded
$0

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Recorded/CD

Zero-Injury Workplace Culture vs. Safety Culture

Speaker: Joe Keenan
Product ID: 704986
Duration: 60 Min

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.

CD/Recorded
$0

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Recorded/CD

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

Speaker: Steven Wachs
Product ID: 704315
Duration: 90 Min

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

CD/Recorded
$0

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Recorded/CD

How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters

Speaker: Dennis Moore
Product ID: 700221
Duration: 60 Min

This Software Auditing Procedure training will discussion on FDA software Standard “General Principles of Software Validation”, Actual FDA investigator software auditing techniques for software failure investigations.

CD/Recorded
$299

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Recorded/CD

Digital Payments 2024 – the future of payments

Speaker: Stanley Epstein
Product ID: 704753
Duration: 120 Min

This webinar examines the current state of the payments industry - from the complexity of the current payments landscape, the growing range of bank and non-bank participants, the ever-increasing range of payments methods, interfaces and systems, open banking, regulation and the future payments scene. We also look at how the COVID-19 pandemic has and will continue to affect payments.

CD/Recorded
$279

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Recorded/CD

What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained

Speaker: Vinny Sastri
Product ID: 701057
Duration: 85 Min

This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.

CD/Recorded
$349

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Recorded/CD

Selection and Use of (Certified) Reference Material- Strategies for FDA Compliance and Tools for Implementation

Speaker: Dr. Ludwig Huber
Product ID: 700900
Duration: 80 Min

This Webinar will highlight the requirements of ISO 17025 and ISO 34 and explain the preparation, testing of certified reference materials along with assessment of suppliers of reference materials.

CD/Recorded
$399

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Recorded/CD

Excel Spreadsheets and FDA Device Regulations

Speaker: Daniel O Leary
Product ID: 701271
Duration: 60 Min

This Spread Sheet Validation training/ webinar explains FDA requirements for Excel spreadsheets used in production or the quality system. The regulations come from 21 CFR §820.70(i) Automated Processes and 21 CFR Part 11.

CD/Recorded
$399

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Recorded/CD

Introduction to disaster/emergency management and business continuity programs

Speaker: Bill Greulich
Product ID: 701337
Duration: 60 Min

This Risk management training module will describe a common set of criteria for disaster/emergency management and business continuity programs.

CD/Recorded
$199

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Recorded/CD

Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry Part II

Speaker: Robert J Russell
Product ID: 701267
Duration: 90 Min

This Regulatory compliance training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

CD/Recorded
$0

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Recorded/CD

Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry PART I

Speaker: Robert J Russell
Product ID: 701260
Duration: 60 Min

The Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

CD/Recorded
$0

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Recorded/CD

Japanese PAL - JPAL QMS requirements in Ordinance 169 and differences to ISO 13485

Speaker: Phil Smart
Product ID: 701290
Duration: 90 Min

This JPAL (Japanese Pharmaceutical Affairs Law) QMS training/webinar will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.

CD/Recorded
$299

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Recorded/CD

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

Speaker: Robert J Russell
Product ID: 701266
Duration: 90 Min

This Japan Regulatory Filing training for life sciences is designed to provide an overview of the regulatory environment in Japan.

CD/Recorded
$0

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Recorded/CD

Good Laboratory Practices (GLP): Documenting Deviations & Unexpected Circumstances

Speaker: Celeste Rose
Product ID: 701246
Duration: 60 Min

This Good Laboratory Practice training defines deviations and unexpected events, the similarities and differences between deviations and amendments, and will present strategies to minimize the occurrence of unnecessary deviations.

CD/Recorded
$249

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Recorded/CD

Use of Spreadsheets to Report Data in FDA Regulated Industries

Speaker: Robert Ferer
Product ID: 701298
Duration: 60 Min

This Spreadsheet validation training will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use.

CD/Recorded
$299

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Recorded/CD

Japanese PAL - Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder)

Speaker: Phil Smart
Product ID: 701277
Duration: 90 Min

This JPAL training will describe requirements, common mistakes & best practices while dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder).

CD/Recorded
$299

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Recorded/CD