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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
Basel III – What's new vs. Basel II

Basel III – What's new vs. Basel II

  • Speaker: Varun Agarwal
  • Product ID: 703273
  • Duration: 90 Min
This Basel III training will focus on the key aspects of Basel III and highlight how it differs from those in Basel II. It will discuss additional compliance requirements for Basel III, the costs involved, implementation timelines and provide a framework for end-to-end implementation.
CD/Recorded
$149
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Recorded/CD
3-hr Virtual Seminar: FDA's Establishment Registration and Product Listing Requirements, User Fees, Fee Waivers and Market Exclusivity

3-hr Virtual Seminar: FDA's Establishment Registration and Product Listing Requirements, User Fees, Fee Waivers and Market Exclusivity

  • Speaker: Karl M. Nobert
  • Product ID: 703269
  • Duration: 3 hrs
This 3-hour training will review and compare FDA’s Establishment Registration and Product Listing Requirements; and available User Fees, Fee Waivers and Marketing Exclusivity for Drugs, Biologics, Medical Devices, Food, Tobacco and Animal Health Products.
CD/Recorded
$499
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Recorded/CD
Managing Products in California: Compliance with Prop 65, Green Chemistry and the Rigid Plastic Packaging Act

Managing Products in California: Compliance with Prop 65, Green Chemistry and the Rigid Plastic Packaging Act

  • Speaker: Lee N Smith
  • Product ID: 703266
  • Duration: 60 Min
This webinar will provide an in-depth understanding of California specific laws, affecting food and other product manufacturers and marketers, such as the Prop 65, the Green Chemistry Initiative, and the Rigid Plastic Packaging Act. We will discuss these laws, how to comply with them and avoid litigation.
CD/Recorded
$229
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Recorded/CD
Creating and Implementing a Human Capital Strategy and Plan - First Step Toward Profitability and Compliance

Creating and Implementing a Human Capital Strategy and Plan - First Step Toward Profitability and Compliance

  • Speaker: Clark Ingram
  • Product ID: 703252
  • Duration: 60 Min
This HR compliance training will provide attendees simple but powerful tools for creating and implementing an effective human capital strategy and plan which will drive out costs, increase Return on Investment (ROI) and get the results one requires.
CD/Recorded
$149
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Recorded/CD
Pharmaceutical Government Price Reporting: Impact of Obamacare

Pharmaceutical Government Price Reporting: Impact of Obamacare

  • Speaker: Ben Barrameda
  • Product ID: 703286
  • Duration: 60 Min
This webinar on drug price reporting will discuss the changes to the Medicaid Drug Program and its impact on pharmaceutical and biotech companies.
CD/Recorded
$149
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Recorded/CD
Archiving Clinical Trial Documents - Understanding Regulatory Requirements for Paper and Electronic Records

Archiving Clinical Trial Documents - Understanding Regulatory Requirements for Paper and Electronic Records

  • Speaker: Eldin Rammell
  • Product ID: 703265
  • Duration: 60 Min
This webinar will cover regulatory requirements for archiving clinical trial documents, both paper and electronic records. It will focus on the key components of a digital preservation strategy to ensure the ongoing retrievability and accessibility of clinical trial electronic records.
CD/Recorded
$229
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Recorded/CD
Marketing Beverages, Fruit Juice and Sports Drinks in Compliance with FDA Regulations

Marketing Beverages, Fruit Juice and Sports Drinks in Compliance with FDA Regulations

  • Speaker: Anthony Pavel
  • Product ID: 703033
  • Duration: 60 Min
This training on marketing of beverages, fruit juice and sports drinks will focus on FDA’s labeling regulations and requirements, FTC enforcement of advertising claims, and recent developments in consumer class action lawsuits involving beverages. Attendee will learn best practices to ensure compliance with FDA and FTC regulations.
CD/Recorded
$229
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Recorded/CD
Cal/OSHA Inspections and Citations - Proven Strategies for Success

Cal/OSHA Inspections and Citations - Proven Strategies for Success

  • Speaker: Don Dressler
  • Product ID: 703007
  • Duration: 60 Min
This webinar will review recent inspection focus areas by Cal-OSHA inspectors, discuss how you should prepare for the inspection, and demonstrate proven strategies that will help you be successful both during the inspection as well as afterwards if there are violations and citations to deal with.
CD/Recorded
$149
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Recorded/CD
Auditing Your Compliance Team - Maintaining independence

Auditing Your Compliance Team - Maintaining independence

  • Speaker: Denise Cicchella
  • Product ID: 703244
  • Duration: 60 Min
This GRC training will provide the attendees best practices for auditing their compliance team. Learn how to identify the strengths and weaknesses of your internal compliance departments.
CD/Recorded
$149
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Recorded/CD
Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)

Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)

  • Speaker: Cheryl Wagoner
  • Product ID: 703235
  • Duration: 60 Min
The webinar will familiarize participants with the FDA's Refuse to Accept Policy for medical device 510(k)’s and help you ensure that your 510(k) application is not rejected for lack of administrative completeness.
CD/Recorded
$229
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Recorded/CD
Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body

Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body

  • Speaker: Bob Michalik, JD, RAC Michalik
  • Product ID: 700691
  • Duration: 60 Min
This training on legal writing for regulatory submissions will provide practical tips that have proven to enhance the persuasiveness of regulatory submissions and help you succeed even if some of your test results or other supporting information are lacking.
CD/Recorded
$50
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Recorded/CD
Risk Factors in EEOC Compliance

Risk Factors in EEOC Compliance

  • Speaker: Bob McKenzie
  • Product ID: 703224
  • Duration: 60 Min
This training will discuss how to comply with Equal Employment Opportunity Laws, EEOC's investigative tactics and enforcement and what you can do to avoid discrimination charges.
CD/Recorded
$149
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Recorded/CD
How to Audit the ERM function

How to Audit the ERM function

  • Speaker: Denise Cicchella
  • Product ID: 703240
  • Duration: 60 Min
This training will provide the attendees best practices for auditing the Enterprise Risk Management function. Learn the role and importance of audit in maintaining the effectiveness of ERM program.
CD/Recorded
$149
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Recorded/CD
Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

  • Speaker: Roger Toothaker
  • Product ID: 703214
  • Duration: 60 Min
This training on FDA compliance will provide the attendees with an understanding of FDA expectations regarding end-of-phase 2A meeting guidance. Attendees will learn the best practices to comply with the intent of the guidance and to achieve a higher quality outcome from the meeting.
CD/Recorded
$229
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Recorded/CD
Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for My Program

Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for My Program

  • Speaker: Adam Ruskin
  • Product ID: 703210
  • Duration: 90 Min
This training on clinical compliance will focus on the requirements of trial master file (TMF) for pharmaceutical product, biotech, a medical device or a diagnostic product. Attendees will learn the best practices to ensure that the TMF is ready for inspection by the regulatory authority.
CD/Recorded
$229
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Recorded/CD
US FDA 510(k): Best Practices for 510(k) Preparation and Submission

US FDA 510(k): Best Practices for 510(k) Preparation and Submission

  • Speaker: David Lim
  • Product ID: 703218
  • Duration: 60 Min
This webinar will discuss best practices for premarket notification [510(k)] preparation and submission compliant with FDA's eCopy and Refuse to Accept (RTA) Policy requirements.
CD/Recorded
$229
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Recorded/CD
Clinical Trial Billing - Building a Compliant Process that Works!

Clinical Trial Billing - Building a Compliant Process that Works!

  • Speaker: Robert Romanchuk
  • Product ID: 702426
  • Duration: 90 Min
This webinar will show how you can devise a clinical trial billing system/ process to manage the billing of clinical trial charges in compliance with Federal rules and regulations.
CD/Recorded
$50
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Recorded/CD
Drug Master Files: New Requirements under GDUFA

Drug Master Files: New Requirements under GDUFA

  • Speaker: Camille Davis Thornton
  • Product ID: 703209
  • Duration: 60 Min
This training on Generic Drug User Fee Amendments of 2012 will discuss the new requirements under GDUFA and effect of GDUFA on the Drug Master File (DMF) process.
CD/Recorded
$229
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Recorded/CD
Complying with Regional Trade Agreements (RTAs) to Expand Internationally

Complying with Regional Trade Agreements (RTAs) to Expand Internationally

  • Speaker: Andrea Ewart
  • Product ID: 703228
  • Duration: 90 Min
This trade webinar will cover existing and pending RTAs, the opportunities and challenges they present for your business, the new rules and procedures and how you can comply with them. It will discuss major RTAs involving the US and the EU and opportunities for exporters of goods.
CD/Recorded
$149
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Recorded/CD
Contract Lifecycle Management: a Practical Framework, Do you have effective processes and controls in place to manage your legacy contracts

Contract Lifecycle Management: a Practical Framework, Do you have effective processes and controls in place to manage your legacy contracts

  • Speaker: Mark J Alexander
  • Product ID: 703103
  • Duration: 60 Min
This compliance training will provide you simple but powerful tools to effectively manage your legacy contracts. Learn the best practices to implement the processes and controls for contract management at your organization.
CD/Recorded
$149
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