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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
How to file a 510(k) when your device is (or contains) software

How to file a 510(k) when your device is (or contains) software

  • Speaker: Cheryl Wagoner
  • Product ID: 703366
  • Duration: 75 Min
The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.
CD/Recorded
$299
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Recorded/CD
How to Create Legally Compliant Commission Agreements

How to Create Legally Compliant Commission Agreements

  • Speaker: Stephanie Yang
  • Product ID: 703343
  • Duration: 60 Min
This webinar will focus on the requirements of a commission agreement in California and differences between an earned commission and an unearned commission. Attendees will learn best practices for creating commission agreements for California employees and how to avoid the pitfalls.
CD/Recorded
$149
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Recorded/CD
Managing the Trial Master File - Considerations for Moving to Electronic TMFs

Managing the Trial Master File - Considerations for Moving to Electronic TMFs

  • Speaker: Eldin Rammell
  • Product ID: 703256
  • Duration: 60 Min
This clinical compliance training will review what issues one needs to consider if one’s organization is thinking about introducing an IT solution for the management of trial master file content. Attendees will gain an understanding of how to comply with the regulatory requirements that are pertinent to the maintenance of the TMF and how to choose efficient supporting TMF processes.
CD/Recorded
$229
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Recorded/CD
Supplier Quality Management: Implement it Now or Pay for it Later

Supplier Quality Management: Implement it Now or Pay for it Later

  • Speaker: Les Schnoll
  • Product ID: 703357
  • Duration: 90 Min
This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.
CD/Recorded
$229
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Recorded/CD
Travel Pay and Expense Reimbursements - Do You Comply with the Law?

Travel Pay and Expense Reimbursements - Do You Comply with the Law?

  • Speaker: Miles Hutchinson
  • Product ID: 703342
  • Duration: 90 Min
This webinar will explain various laws affecting travel pay and expense reimbursements. Attendees will learn best practices to comply with federal travel regulations.
CD/Recorded
$149
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Recorded/CD
Are you prepared for a regulatory audit from FDA or any other regulatory body?

Are you prepared for a regulatory audit from FDA or any other regulatory body?

  • Speaker: Philip Russ
  • Product ID: 703355
  • Duration: 90 Min
This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
CD/Recorded
$229
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Recorded/CD
Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance

Major Changes to the EU Clinical Trials Regulation: What is Required for Compliance

  • Speaker: Laura Brown
  • Product ID: 703336
  • Duration: 60 Min
This webinar will help Sponsors, CROs and study sites running clinical trials in the EU and internationally; understand the important, updated compliance requirements concerning the new EU Clinical Trials Regulation due to be enacted in 2016 and which will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC).
CD/Recorded
$229
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Recorded/CD
Optimize Your Import Contracts for Compliance and Risk Management

Optimize Your Import Contracts for Compliance and Risk Management

  • Speaker: Scott Lowden
  • Product ID: 703326
  • Duration: 60 Min
This webinar will provide tools and tips for optimizing imports contracts to ensure compliance and reduce risk. Attendees will be able to review their contracting practices, PO forms and purchasing procedures to make the best use of their advantages as a buyer.
CD/Recorded
$50
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Recorded/CD
Regulatory Documentation for Clinical Trials

Regulatory Documentation for Clinical Trials

  • Speaker: Adam Ruskin
  • Product ID: 703329
  • Duration: 60 Min
This clinical research compliance training will explain in detail the list of required regulatory documentation for clinical trials for industries such as pharmaceutical, biotechnology, medical devices and diagnostics. It will also review many of the documents in terms of required content and structure.
CD/Recorded
$229
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Recorded/CD
All about NAFTA and its Impact if You Have to Abide by It

All about NAFTA and its Impact if You Have to Abide by It

  • Speaker: David Ross
  • Product ID: 703348
  • Duration: 60 Min
The webinar will provide detailed information on how to comply with NAFTA basics such as Harmonized Tariff classification, valuation, Country of Origin determination and marking requirements. Attendees will also learn how to comply with NAFTA’s often complex rules for eligibility thus mitigating the risk of violations that are subject to stiff fines and penalties from US, Canadian and Mexican Customs authorities.
CD/Recorded
$149
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Recorded/CD
Independent Contractor or Employee - Guidelines to Insure Compliance

Independent Contractor or Employee - Guidelines to Insure Compliance

  • Speaker: Kenneth Sprang
  • Product ID: 703227
  • Duration: 60 Min
This webinar will discuss the criteria used by the DOL, the EEOC and the IRS to distinguish between contractors and employees and how you can avoid mis-classifying employees as independent contractors.
CD/Recorded
$149
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Recorded/CD
Valuation: How to Determine Customs Value

Valuation: How to Determine Customs Value

  • Speaker: Reynaldo Roman
  • Product ID: 703304
  • Duration: 60 Min
This webinar will explain the WTO Agreement on Customs value and valuation methods. Attendees will learn how to use the valuation methods to determine Customs value.
CD/Recorded
$149
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Recorded/CD
Managing Export Authorizations during the ECR Transition Period: How to Maximize Efficiency While Minimizing Risk

Managing Export Authorizations during the ECR Transition Period: How to Maximize Efficiency While Minimizing Risk

  • Speaker: Darrell Coleman
  • Product ID: 703311
  • Duration: 60 Min
This webinar will explain how to manage export authorizations during the transition of products to the Export Administration Regulations (EAR). It will discuss advantages and disadvantages associated with transitioning products as well as the various exceptions available including the STA exception for the new 600 Series products.
CD/Recorded
$149
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Recorded/CD
Essential Do's and Don'ts for Navigating a Successful 505(b)(2) Drug Application

Essential Do's and Don'ts for Navigating a Successful 505(b)(2) Drug Application

  • Speaker: Thomas Reilly
  • Product ID: 703314
  • Duration: 60 Min
This FDA New Drug Approval process training will provide attendees with the knowledge and skills needed to develop a successful 505 (b)(2) program.
CD/Recorded
$229
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Recorded/CD
Understanding and Interpreting the EMA Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or electronic) for Management, Audit and Inspection of Clinical Trials

Understanding and Interpreting the EMA Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or electronic) for Management, Audit and Inspection of Clinical Trials

  • Speaker: Eldin Rammell
  • Product ID: 703281
  • Duration: 60 Min
This training will give attendees an insight into the interpretation of GCP regulations by the European Medicines Agency (EMA) as they relate to the management of trial documents, focusing especially on clarification within the paper on disputed and ambiguous areas of trial master file (TMF) management.
CD/Recorded
$229
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Recorded/CD
7 Pillars of an Effective Compliance Program for Healthcare Companies: Lessons Learned from a Prosecutor's Perspective

7 Pillars of an Effective Compliance Program for Healthcare Companies: Lessons Learned from a Prosecutor's Perspective

  • Speaker: Alice H Martin,Michael Rosen
  • Product ID: 703280
  • Duration: 60 Min
This healthcare best practices training will discuss the seven recognized pillars that a compliance plan should include and the details that will allow attendees to reduce their company’s potential liability under the Federal U.S. Sentencing Guidelines. Learn from examples of healthcare companies that did not have or follow an effective compliance plan and the resulting civil fines and penalties as well as government oversight and audits that ensued.
CD/Recorded
$229
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Recorded/CD
3 Ways to Avoid Costly Wage and Hour Problems

3 Ways to Avoid Costly Wage and Hour Problems

  • Speaker: Michael Haberman
  • Product ID: 703293
  • Duration: 60 Min
This Fair Labor Standards Act compliance training will focus on the ways to avoid costly wage and hour problems under FLSA. Attendees will learn exempt classification and how to calculate overtime.
CD/Recorded
$50
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Recorded/CD
Illegal Harassment v/s Legal Workplace Bullying

Illegal Harassment v/s Legal Workplace Bullying

  • Speaker: Catherine Mattice Zundel
  • Product ID: 703291
  • Duration: 60 Min
This training will help you understand the concept of workplace bullying. You will understand the similarities and differences between illegal harassment with legal workplace bullying & how to handle them. Attendees will learn tools for managing bullying at work.
CD/Recorded
$149
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Recorded/CD
How To Translate Academic and Discovery Assays Into GLP Compliant Assays

How To Translate Academic and Discovery Assays Into GLP Compliant Assays

  • Speaker: Todd Graham
  • Product ID: 703275
  • Duration: 60 Min
This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.
CD/Recorded
$229
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Recorded/CD
Annual Risk Assessment (ARA) - Keys to Maximize the value of an Internal Audit Department

Annual Risk Assessment (ARA) - Keys to Maximize the value of an Internal Audit Department

  • Speaker: Robert Brewer
  • Product ID: 703297
  • Duration: 75 Min
This webinar will cover how to have an effective Annual Risk Assessment (ARA) and internal audit’s role in ARA. You will be able to identify the appropriate risk framework, their risk rankings, and balancing their available resources.
CD/Recorded
$149
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