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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
The Evolving State of U.S Sanctions Against Iran

The Evolving State of U.S Sanctions Against Iran

  • Speaker: Erich C. Ferrari
  • Product ID: 704021
  • Duration: 60 Min
This training program will offer attendees an understanding of U.S. sanctions targeting Iran, varying compliance obligations, and OFAC’s licensing policies. It will also discuss remaining Iran sanctions compliance obligations.
CD/Recorded
$149
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Recorded/CD
Lyophilization Technology

Lyophilization Technology

  • Speaker: Jerry Dalfors
  • Product ID: 704028
  • Duration: 80 Min
This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.
CD/Recorded
$229
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Recorded/CD
FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

  • Speaker: Mukesh Kumar
  • Product ID: 703652
  • Duration: 90 Min
This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.
CD/Recorded
$229
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Recorded/CD
How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices

How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices

  • Speaker: David Lim
  • Product ID: 703245
  • Duration: 60 Min
This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.
CD/Recorded
$229
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Recorded/CD
Good Documentation Practices (GDP)

Good Documentation Practices (GDP)

  • Speaker: Alla Teresh
  • Product ID: 703874
  • Duration: 60 Min
This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.
CD/Recorded
$229
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Recorded/CD
Payroll Record Keeping: Who Requires What, for How Long and in What Format

Payroll Record Keeping: Who Requires What, for How Long and in What Format

  • Speaker: Diana Chomichuk
  • Product ID: 703755
  • Duration: 60 Min
Personnel records are documentation of an individual's employment history encompassing all employment-related information collected and maintained by the employer. These essential documents form the foundation upon which employment actions are based. This webinar will illustrate key concepts in managing personnel records to protect your organization from potential exposure and security threats.
CD/Recorded
$149
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Recorded/CD
Corrective and Preventive Action Utilizing the Principles of Lean Documents and Lean Configuration

Corrective and Preventive Action Utilizing the Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703879
  • Duration: 90 Min
This training program on lean documents will present a fresh departure from general practices, while building upon proven principles. The theory of lean documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and push systems, many traditional document practices are artifacts of a flawed approach. This webinar will highlight how lean configuration comes from the same principles, and utilizes the unique power of software solutions to take over functions that had previously burdened controlled paper documents.
CD/Recorded
$229
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Recorded/CD
Veterinary Drug Approval Process and FDA's Regulatory Oversight

Veterinary Drug Approval Process and FDA's Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703971
  • Duration: 60 Min
This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.
CD/Recorded
$0
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Recorded/CD
BSA, De-Risking: Why De-Risk When You Can Re-Risk?

BSA, De-Risking: Why De-Risk When You Can Re-Risk?

  • Speaker: Laura H Goldzung
  • Product ID: 703985
  • Duration: 90 Min
This webinar will highlight the opportunity to define enhanced diligence that can be used for conducting an effective high risk review in order to ensure compliance with Bank Secrecy Act (BSA) regulations and regulatory expectations.
CD/Recorded
$149
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Recorded/CD
Be Ready for eMDR Going Live August 14, 2015

Be Ready for eMDR Going Live August 14, 2015

  • Speaker: Rita Hoffman
  • Product ID: 703972
  • Duration: 110 Min
This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).
CD/Recorded
$249
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Recorded/CD
Preparing for and Managing FDA Inspections

Preparing for and Managing FDA Inspections

  • Speaker: Jonathan M Lewis
  • Product ID: 703512
  • Duration: 90 Min
This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.
CD/Recorded
$279
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Recorded/CD
2015 OFAC Sanction, Related Export Control Violations and Enforcement Trends: Best Practices for Preventing Violations

2015 OFAC Sanction, Related Export Control Violations and Enforcement Trends: Best Practices for Preventing Violations

  • Speaker: Robert J Ward Jr
  • Product ID: 703919
  • Duration: 90 Min
This training program will update participants on the developments regarding OFAC sanctions, OFAC enforcement trends as well as related export control traps for the unwary. The discussion of OFAC sanction developments will give participants an appreciation of the new war chest of punitive measures being deployed in recent executive orders.
CD/Recorded
$50
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Recorded/CD
Deep Dive Overview: TILA/RESPA Integrated Disclosures

Deep Dive Overview: TILA/RESPA Integrated Disclosures

  • Speaker: Kara Lamphere
  • Product ID: 703978
  • Duration: 60 Min
This training program will discuss the changes to initial and closing disclosures relative to TILA and RESPA. It will offer attendees a clearer understanding of changes to variance thresholds, affiliate relationships, and illustrate the importance of knowing your fees and avoiding closing delays.
CD/Recorded
$149
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Recorded/CD
India's Import-Export Policy and Procedures - Best Practices and Risks

India's Import-Export Policy and Procedures - Best Practices and Risks

  • Speaker: Deep SenGupta
  • Product ID: 703968
  • Duration: 90 Min
This training program will discuss the historical context of India's current trade policy and overview India's commercial climate and market access issues. The course will also highlight top import and export compliance errors, and strategies for smooth trade facilitation into and out of India.
CD/Recorded
$149
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Recorded/CD
Importing Pharmaceutical Products: What Every Importer of Drugs and APIs Should Know

Importing Pharmaceutical Products: What Every Importer of Drugs and APIs Should Know

  • Speaker: Reynaldo Roman
  • Product ID: 703960
  • Duration: 90 Min
This training program will focus on U.S. import entry compliance and FDA import entry compliance. U.S. import requirements for pharmaceutical products are among the most rigorous of any country. As a result, it is critical for importers of drugs and APIs to know and comply with these requirements. Failure to comply with U.S. import requirements may result in clearance delays or import shipments being refused entry into the U.S.
CD/Recorded
$229
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Recorded/CD
Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans

Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans

  • Speaker: Laura Brown
  • Product ID: 703929
  • Duration: 60 Min
This training program will discuss latest requirements for monitoring plans, content and process requirements including FDA monitoring guidance and EU requirements. The webinar will help, sponsors, and CROs in the US, EU and internationally, understand how to effectively draft monitoring plans and comply with the latest FDA and EU inspection requirements for monitoring clinical trials.
CD/Recorded
$229
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Recorded/CD
Workplace Investigations

Workplace Investigations

  • Speaker: Diana Chomichuk
  • Product ID: 703497
  • Duration: 60 Min
This webinar will provide attendees tools and tips for conducting workplace investigations that are fair, third-party objective, and legally defensible. It will explain the essential elements of an effective investigation.
CD/Recorded
$149
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Recorded/CD
Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements

Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements

  • Speaker: Gretchen Bowker
  • Product ID: 702741
  • Duration: 60 Min
This dietary supplements quality compliance training will review the FDA regulatory requirements for manufacturing and commercialization of dietary supplements. You will gain a complete understanding of FDA requirements for manufacturing of nutraceuticals, food drugs, and dietary supplements.
CD/Recorded
$229
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Recorded/CD
How to Conduct an Internal Investigation - Vital Piece of EEO Compliance

How to Conduct an Internal Investigation - Vital Piece of EEO Compliance

  • Speaker: Gayla Sherry
  • Product ID: 703826
  • Duration: 60 Min
No two investigations are the same – even a seasoned veteran who has handled discrimination complaints and conducted internal investigations can still benefit from a deeper understanding of how to ensure EEO compliance. The risk of not properly conducting an investigation is substantial in terms of fines, penalties and settlements, but also court costs and deterioration in the organization’s reputation. This webinar will present plain language ideas for conducting investigations.
CD/Recorded
$149
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Recorded/CD
FDA vs. EU Inspections - Getting Prepared and What are Differences

FDA vs. EU Inspections - Getting Prepared and What are Differences

  • Speaker: Marie Dorat
  • Product ID: 703516
  • Duration: 75 Min
This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
CD/Recorded
$229
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