
Comparability Protocols (CPs): How and when to use them for Post Approval Changes
James E Ingram
120 Min
Product Id: 701315
This Comparability Protocols training will provide you with the basics for use as well as provide you with new and expanded ways of using CPs. It will also assist you in finding ways to help shorten the time for implementing pre and post approval changes.

Spreadsheet Validation: Understanding and satisfying FDA requirements
Alfonso Fuller
60 Min
Product Id: 701194
This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.

Managing Your Worker's Compensation Claims - The Ultimate Guide
Don Dressler
60 Min
Product Id: 703143
This webinar will discuss how to manage your employees' compensation claims from before the accident or injury until the claim is closed and the employee is back to work.

Medical Necessity - Primer on Key Legal Principles and Operational Compliance
John Steiner
90 Min
Product Id: 703145
This webinar on the legal principles of 'Medical Necessity' will cover the compliance background and provide practical advice on how healthcare providers can understand and apply ‘medical necessity’ principles.

FAA Drug and Alcohol Testing Requirements - How to Comply with Title 14 Code of Federal Regulations (CFR) part 120 and 49 CFR Part 40
Greg Fredenburg
60 Min
Product Id: 702470
This webinar will provide an emphasis on how to easily understand the FAA requirements relative to drug and alcohol testing and how to prepare for an FAA audit of an FAA approved Drug and Alcohol program.

GLP or GMP: A Comparison in Terms and Application for Drugs and Biologics
Janet Rose Rea
60 Min
Product Id: 701911
This webinar will discuss the terms GLP and GMP, their definition, similarities and differences and their application in the biologics or pharmaceuticals development environment.

Recordkeeping Requirements for Import Trade Compliance - As per U.S. CBP
Michael Laden
60 Min
Product Id: 702760
This import trade compliance recordkeeping webinar will cover the requirements for management and retention of critical trade records and data as mandated by U.S. Customs and Border Protection (CBP).

Bringing Compliance To Design Control For Older Products
Rob Braido
60 Min
Product Id: 701150
This webinar will discuss the procedures that medical device companies need to follow to bring their product design history files up to date with the new standards.

Virtual Currencies, Cyber-Payments and Regulatory Compliance
Juan Llanos
60 Min
Product Id: 703125
This training on virtual currencies compliance will elucidate the rise, purpose, operational intricacies, societal benefits and multiple risks of Bitcoin and the emerging breed of alternative digital currencies. Attendees will learn tools and techniques to manage the risks posed by virtual currencies.

Payment issues- how can companies minimize the risk of duplicate, fraudulent, and late payments?
Brent Meyers
60 Min
Product Id: 703175
This training on financial transactions risk management will highlight a myriad of issues that can exist in a company’s payment process. The reasons may be simple, but the outcome can be expensive.

Best Documentation Practices for FDA Compliance
Nick Campbell
60 Min
Product Id: 701774
This webinar will discuss the best practices for documentation for FDA regulated companies. You will learn techniques and ideas that will help you identify effective methods to improve your document control systems.

Supplier Quality Agreements for Medical Devices
Dan OLeary
90 Min
Product Id: 702848
This training on medical device supplier management will explain the elements of a supplier quality agreement and discuss practical steps for implementation.

How to Investigate Environmental Monitoring Excursions Limits
Gerry O Dell
60 Min
Product Id: 701504
This environmental monitoring training will review the best practices for setting environmental monitoring alert and action levels for viable and non-viable data including product bioburden. In addition this webinar will address the responses/actions that should be taken when an excursion in the alert or action level occurs.

B.Y.O.D. in a Healthcare Setting - Risks, Policies and Procedures, Access Controls and More
Paul Frisch
90 Min
Product Id: 703171
This webinar will discuss the best practices for protecting the privacy and security of Protected Health Information (PHI) when clinicians, other healthcare personnel and patients use their own devices to access PHI.

FDA Regulation in Pharmacy Compounding - Risks and Critical Issues to Consider
J Mason Weeda
75 Min
Product Id: 703164
This webinar on FDA Pharmacy Compounding will detail the current thinking, the efforts made and steps taken by FDA and legislatures since the “meningitis outbreak” in 2012.

Essentials of U.S. Import Compliance
Zainab Nasser
90 Min
Product Id: 703139
This comprehensive, information-packed webinar highlights the changes in the Customs Modernization Act of 1993 (Mod Act) that has shifted more accountability to the importer of record. The session will help you understand, while the importer may utilize the services of a licensed customs broker to handle their declarations on the customs entry, the importer retains responsibility to ensure the goods are entered with accurate tariff classification, valuation, and country of origin. The importer must also follow all labeling, marking and recordkeeping requirements, and any trade restrictions that may affect the importation.
All about OSHA Recordkeeping Misconceptions and Interpretations
William Principe
120 Min
Product Id: 702339
This 2-hour OSHA injury and illness recordkeeping training will teach you how OSHA analyzes recordkeeping scenarios by focusing on those concepts and rules that are most commonly misunderstood by recordkeepers and their bosses

Process Capability Indices in Medical Device Manufacturing
Daniel O Leary
90 Min
Product Id: 703141
This webinar will help device manufacturers to identify valid statistical techniques to control process capability and product characteristics. It will explain process capability indices in detail and their use.

The Interdisciplinary Chart: How can this affect your reimbursement?
Laura S Hargraves
90 Min
Product Id: 703112
This webinar will teach you how to look at your interdisciplinary chart from a comprehensive standpoint. We will discuss how to perform an internal audit on your chart to ensure it can pass RAC audits and audits by State Survey teams.

Transferring Medical Device Production to a Contract Manufacturer - Decision Making Process and Procedures
Rob Braido
90 Min
Product Id: 702719
This webinar on outsourcing medical device manufacturing will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house. If you decide to transfer production, then this training will detail the options and next steps to transferring it to the right facility or contract manufacturer.