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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
Failure Modes and Effects Analysis - An effective Risk Management Tool

Failure Modes and Effects Analysis - An effective Risk Management Tool

  • Speaker: John Chapman
  • Product ID: 701138
  • Duration: 60 Min
This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
CD/Recorded
$299
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Recorded/CD
Current Concepts and Challenges in Cloud Compliance

Current Concepts and Challenges in Cloud Compliance

  • Speaker: Angela Bazigos
  • Product ID: 703739
  • Duration: 90 Min
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
CD/Recorded
$299
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Recorded/CD
3-Hr Virtual Seminar: Import and Export with Latin America: Argentina, Brazil and Venezuela

3-Hr Virtual Seminar: Import and Export with Latin America: Argentina, Brazil and Venezuela

  • Speaker: Raymond Sullivan
  • Product ID: 704646
  • Duration: 3 hrs
This training program on Latin America import and export will detail the US requirements to export and import procedures to Latin America. It will also discuss commercial and customs document requirements, tariffs and applicable duties, countervailing and antidumping duties, and highlight the difference between automatic and non-automatic import licenses.
CD/Recorded
$199
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Recorded/CD
CDISC Mapping 1: Specifications and FDA Requirements

CDISC Mapping 1: Specifications and FDA Requirements

  • Speaker: Sunil Gupta
  • Product ID: 704152
  • Duration: 90 Min
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
CD/Recorded
$299
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Recorded/CD
FATCA - The Foreign Accounts Tax Compliance Act

FATCA - The Foreign Accounts Tax Compliance Act

  • Speaker: Miles Hutchinson
  • Product ID: 703242
  • Duration: 90 Min
This training on Foreign Accounts Tax Compliance Act will teach the attendees best practices to ensure compliance with FATCA. Learn how to comply with your withholding and reporting obligations.
CD/Recorded
$249
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Recorded/CD
Panama Papers and PEP Screening - KYC and Sanctions Filtering

Panama Papers and PEP Screening - KYC and Sanctions Filtering

  • Speaker: Armen Khachadourian
  • Product ID: 704630
  • Duration: 90 Min
This training program will explore the operational implications of dealing with heightened-risk categories such as PEP screening at the heels of the Panama Papers controversy. The program will also discuss the current changes in the marketplace and expose the new faces of AML and examine areas of PEP regulation that pose present and future challenges for regulated businesses.
CD/Recorded
$249
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Recorded/CD
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703396
  • Duration: 90 Min
This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.
CD/Recorded
$249
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Recorded/CD
How to prepare for a CBP Audit

How to prepare for a CBP Audit

  • Speaker: Raymond Sullivan
  • Product ID: 705352
  • Duration: 60 Min
This CBP audit preparation training program will help attendees move toward a systematic approach for both general compliance and when notified about a CBP audit. It will help identify the likelihood of being subject to CBP audits, and help spot potential vulnerabilities and test your compliance (potential vulnerability, self review and general audit issues).
CD/Recorded
$179
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Recorded/CD
Assay Validation for Clinical Diagnostics

Assay Validation for Clinical Diagnostics

  • Speaker: Todd Graham
  • Product ID: 702872
  • Duration: 60 Min
This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.
CD/Recorded
$249
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Recorded/CD
Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

  • Speaker: Gwen Wise Blackman
  • Product ID: 705019
  • Duration: 180 Min
This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.
CD/Recorded
$349
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Recorded/CD
Title 19 CFR 171 - U.S Customs Prior Disclosure: Mitigate Risks and Avoid Penalties

Title 19 CFR 171 - U.S Customs Prior Disclosure: Mitigate Risks and Avoid Penalties

  • Speaker: Raymond Sullivan
  • Product ID: 704691
  • Duration: 90 Min
This training program will analyze Title 19 CFR 171 - U.S Customs Prior Disclosure. It will objectively evaluate customs errors and mistakes and define the pros and cons of disclosing to customs. The program will further demonstrate the consequences of disclosure or non-disclosure and remedial measures.
CD/Recorded
$199
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Recorded/CD
Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703423
  • Duration: 75 Min
This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
CD/Recorded
$249
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Recorded/CD
Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

  • Speaker: Gregory Martin
  • Product ID: 705347
  • Duration: 90 Min
This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.
CD/Recorded
$199
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Recorded/CD
Ensuring Integrity and Security of Laboratory Data

Ensuring Integrity and Security of Laboratory Data

  • Speaker: Dr. Ludwig Huber
  • Product ID: 702454
  • Duration: 75 Min
This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.
CD/Recorded
$199
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Recorded/CD
Cyber Incident Response Plans: Planning for the Inevitable

Cyber Incident Response Plans: Planning for the Inevitable

  • Speaker: Rayleen M Pirnie
  • Product ID: 704414
  • Duration: 90 Min
This webinar training analyzes critical components of a Cyber Incident Response Plan and provides recommendations on how to prepare all staff for the inevitable situations. From internal considerations to your external solution providers, get a realistic view of how a cyber-attack can quickly spiral a typical day into complete chaos and cause significant losses without preparation. Attendees will receive a Cyber Incident Response Plan checklist to help their Incident Response Team analyze or develop a Plan.
CD/Recorded
$199
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Recorded/CD
Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging

Safe Use of Ladders and Proper Climbing Practices; Fall Protection on Aerial Lifts; Proper Use of Staging

  • Speaker: John J Meola
  • Product ID: 705493
  • Duration: 90 Min
This webinar will review the best practices associated with use of ladders of all types, including the selection, inspection, storage and transport of ladders, along with safe practice when erecting, climbing, working from and descending a ladder. It will also discuss the process and practices related with aerial lifts and working from buckets on an extended boom.
CD/Recorded
$179
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Recorded/CD
FMLA Abuse: How to Identify, Investigate, Deny, and Terminate

FMLA Abuse: How to Identify, Investigate, Deny, and Terminate

  • Speaker: Vanessa G Nelson
  • Product ID: 703671
  • Duration: 60 Min
This webinar will assist employers with effective strategies to identify, investigate, and terminate FMLA abusers. Additionally, the course will also instruct employers on when it is appropriate to deny FMLA requests in accordance with the law.
CD/Recorded
$199
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Recorded/CD
How to Structure and Write a Job Hazard Analysis / Activity Hazard Analysis (JHA – AHA) in Accordance with OSHA 1926 – EM 385

How to Structure and Write a Job Hazard Analysis / Activity Hazard Analysis (JHA – AHA) in Accordance with OSHA 1926 – EM 385

  • Speaker: John J Meola
  • Product ID: 705500
  • Duration: 90 Min
This webinar will explore the common failures associated with organizing and writing Job Hazard Analysis / Activity Hazard Analysis (JHA – AHA) documents. It will also de-mystify some of the language and concepts in the traditional JHA process, namely the risk assessment calculator.
CD/Recorded
$199
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Recorded/CD
Customs Entry Reconciliation Program - Valuation Errors and Penalties

Customs Entry Reconciliation Program - Valuation Errors and Penalties

  • Speaker: Raymond Sullivan
  • Product ID: 704815
  • Duration: 60 Min
This webinar will explain how to calculate the correct valuation on a product while importing from related party suppliers. Instructor will discuss how to document transactions for CBP process and to recognize valuation issues that may cause price adjustments after import. Participants will learn to avoid adverse consequences of declared valuation errors and what are the downsides to participation in reconciliation.
CD/Recorded
$199
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Recorded/CD
Bank Secrecy Act (BSA), Title 31, Compliance

Bank Secrecy Act (BSA), Title 31, Compliance

  • Speaker: Armen Khachadourian
  • Product ID: 703574
  • Duration: 60 Min
This webinar will review current requirements of the Bank Secrecy Act, why to comply, how to comply, reporting techniques and current positions by the IRS and FinCEN.
CD/Recorded
$249
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