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Home › Online Training ›  Documentation and Policy Management

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.
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Recorded/CD
Updated EU filing and registration procedures (including the new variation rules coming in to force)

Updated EU filing and registration procedures (including the new variation rules coming in to force)

  • Speaker: Robert J Russell
  • Product ID: 701535
  • Duration: 60 Min
This EU filing and Registration webinar will discuss in brief all the new EU clinical directives, its Impact and how companies can effectively align their filing and registrations processes to effectively implement the requirements of the regulations.
CD/Recorded
$229
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Recorded/CD
OSHA's Personal Protective Equipment (PPE) Standard, 29 CFR 1910.132

OSHA's Personal Protective Equipment (PPE) Standard, 29 CFR 1910.132

  • Speaker: Randall Charpentier
  • Product ID: 703587
  • Duration: 90 Min
This webinar will discuss in detail the requirements of personal protective equipment (PPE) and its use. Attendees will learn best practices to ensure compliance with OSHA 29 CFR 1910.132 standard.
CD/Recorded
$149
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Recorded/CD
Food Contact Notification (FCN) - Obtaining New Regulations from FDA on Your Terms

Food Contact Notification (FCN) - Obtaining New Regulations from FDA on Your Terms

  • Speaker: Jeffrey Scott Eberhard
  • Product ID: 703572
  • Duration: 60 Min
This food safety webinar will explain how to thoroughly review a food contact substance, determine its regulatory status and obtain a new regulation from FDA via the FCN process for a substance that does not meet suitable regulatory status.
CD/Recorded
$229
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Recorded/CD
Simplifying the Dietary Supplement cGMPs for Those Confused by the Regulations

Simplifying the Dietary Supplement cGMPs for Those Confused by the Regulations

  • Speaker: Jennifer Medlar
  • Product ID: 703559
  • Duration: 60 Min
This webinar will explain cGMP regulations for dietary supplements. It will provide an overview of key requirements for dietary supplements including written procedures and records required by cGMP. Attendees will learn best practices to comply with these regulations.
CD/Recorded
$229
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Recorded/CD
Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment

Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment

  • Speaker: Jerry Dalfors
  • Product ID: 703560
  • Duration: 90 Min
This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.
CD/Recorded
$229
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Recorded/CD
Effective Management of Intellectual Property Records

Effective Management of Intellectual Property Records

  • Speaker: Charlie Sodano
  • Product ID: 702496
  • Duration: 75 Min
This webinar will show how you can build and maintain research records, that are used to support patent claims, to meet stringent requirements and ensure that they can support in filing patent applications and defend in case of litigation.
CD/Recorded
$50
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Recorded/CD
Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

  • Speaker: David Lilienfeld
  • Product ID: 703479
  • Duration: 90 Min
This pharmacovigilance webinar will provide attendees an understanding of post-marketing drug safety surveillance, its role in lifecycle management, and the practices and regulations governing its conduct. It will describe the structure of the pharmacovigilance world including the ICH, the FDA, CIOMS, MHW, and EudraVigilance.
CD/Recorded
$229
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Recorded/CD
Steps to Design and Develop an Effective Closed Loop Change Control System

Steps to Design and Develop an Effective Closed Loop Change Control System

  • Speaker: Michael Kagan
  • Product ID: 703489
  • Duration: 90 Min
This webinar will discuss how to design an effective change control system – electronic as well as paper-based – with traceability and closed loop verification built into the process.
CD/Recorded
$229
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Recorded/CD
Ensuring Legally-Effective Informed Consent: Basic to Advanced Issues for Investigators and IRBs

Ensuring Legally-Effective Informed Consent: Basic to Advanced Issues for Investigators and IRBs

  • Speaker: George Gasparis
  • Product ID: 703562
  • Duration: 90 Min
This webinar on informed consent will review the regulatory requirements to ensure that legally-effective consent is obtained for enrollment of subjects in human research regulated by the Department of Health and Humans Services (HHS) and/or the Food and Drug Administration (FDA). You will gain an understanding of not only the basic requirements, but also several challenging areas to ensure legally-effective consent.
CD/Recorded
$229
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Recorded/CD
Transforming the Cargo Clearance Process

Transforming the Cargo Clearance Process

  • Speaker: Suzanne Richer
  • Product ID: 703264
  • Duration: 60 Min
This Customs and Border Protection compliance training will help the attendees understand the latest CBP developments relating to the entire cargo clearance process and how these will impact import clearances.
CD/Recorded
$149
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Recorded/CD
Documenting a Risk-Based Quality System - for Compliance and Cost-Savings

Documenting a Risk-Based Quality System - for Compliance and Cost-Savings

  • Speaker: John E Lincoln
  • Product ID: 700354
  • Duration: 90 Min
This webinar will help attendees evaluate their existing Quality Management System (QMS) in light of the changes in the FDA's CGMP / QMS enforcement paradigm. Attendees will learn how to document a risk-based QMS at their organization for both compliance and cost savings.
CD/Recorded
$229
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Recorded/CD
Current Trends in FDA Inspections

Current Trends in FDA Inspections

  • Speaker: Michael Ferrante
  • Product ID: 703485
  • Duration: 90 Min
This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.
CD/Recorded
$229
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Recorded/CD
Giving and Receiving Feedback: How to Create and Improve an Employee Development Plan

Giving and Receiving Feedback: How to Create and Improve an Employee Development Plan

  • Speaker: Gail Birks
  • Product ID: 703506
  • Duration: 60 Min
This webinar will explain different performance appraisal models and will identify the pros and cons of performance appraisals. Attendees will learn how to create and improve an employee development plan.
CD/Recorded
$149
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Recorded/CD
How to Discipline and Discharge a Poor-Performing Employee Where a workers' compensation Claim has been Filed: Avoiding Retaliatory Discharge Lawsuits

How to Discipline and Discharge a Poor-Performing Employee Where a workers' compensation Claim has been Filed: Avoiding Retaliatory Discharge Lawsuits

  • Speaker: Jeffrey Weintraub
  • Product ID: 703503
  • Duration: 60 Min
This webinar will explain how to discharge a poor-performing employee where a workers’ compensation claim has been filed. Attendees will learn how to minimize the risks of retaliatory discharge lawsuits when taking adverse action against these kinds of employees.
CD/Recorded
$149
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Recorded/CD
Supplier Qualification Audit, A Risk Based Approach

Supplier Qualification Audit, A Risk Based Approach

  • Speaker: Yasamin Ameri
  • Product ID: 703477
  • Duration: 60 Min
This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.
CD/Recorded
$229
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Recorded/CD
FDA Guidance: Medical Device Recalls

FDA Guidance: Medical Device Recalls

  • Speaker: Angela Bazigos
  • Product ID: 703473
  • Duration: 90 Min
This webinar will discuss in detail the FDA guidance on medical device recalls including its role, expectations and enforcement policy. It will cover key topics on medical device recall including recall classification, firm’s responsibilities for a recall, recall communication, recall strategy, FDA expectations and much more.
CD/Recorded
$179
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Recorded/CD
Successful Export Controls Compliance: How to Conduct a Thorough Due Diligence for Exports to Sanctioned Countries

Successful Export Controls Compliance: How to Conduct a Thorough Due Diligence for Exports to Sanctioned Countries

  • Speaker: Suzanne Bullitt
  • Product ID: 703282
  • Duration: 60 Min
This export controls compliance training will focus on Office of Foreign Asset Controls (OFAC) regulations. Attendees will learn best practices for managing due diligence processes for their exports when dealing with sanctioned countries.
CD/Recorded
$149
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Recorded/CD
The 510(k) Process and Risk Management

The 510(k) Process and Risk Management

  • Speaker: Edwin L Bills
  • Product ID: 701497
  • Duration: 90 Min
This 510(k) and risk management webinar will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstrate that product is safe.
CD/Recorded
$229
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Recorded/CD
Responding to Unsolicited Requests for Off-Label Information

Responding to Unsolicited Requests for Off-Label Information

  • Speaker: Mukesh Kumar
  • Product ID: 703464
  • Duration: 90 Min
This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.
CD/Recorded
$229
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Recorded/CD
Essentials of Taxing and Reporting Insurance Benefits in 2014 and Beyond

Essentials of Taxing and Reporting Insurance Benefits in 2014 and Beyond

  • Speaker: Vicki M. Lambert
  • Product ID: 703350
  • Duration: 90 Min
This webinar will explain in detail the reporting requirements under the Affordable Health Care Act, calculating group term life insurance and tax ramifications of third party sick pay. Attendees will gain an understanding of the different types of health plans outside of the typical group health insurance and how each must be handled and reported on Form W-2.
CD/Recorded
$149
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