
Creating Effective SOPs for Regulatory Compliance
Henry Urbach
60 Min
Product Id: 702999
This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).

Litigation and Bankruptcy : How Accountants Can Help Clients Minimize Attorney Fees
Candace Leuck
120 Min
Product Id: 704911
In this webinar, you’ll learn about the role accountants can play in managing litigation and bankruptcy to reduce costs for their clients in cash distressed situations.

Payroll Pitfalls-Don't Fall into the Trap for These Five Areas of Payroll
Vicki M. Lambert
90 Min
Product Id: 704871
This webinar training will explain the payroll rules and regulations in today’s world, its complexities and how to understand and detect the compliance and risk requirements to look for. The Instructor will discuss the five biggest payroll pitfalls and how to avoid them.

4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements
Howard Cooper
4 hrs
Product Id: 704915
This 4-hr webinar will focus on product lifecycle concepts that are applicable to all of the FDA regulated industries. Learn the objectives, purpose and scope of the quality manual and how to can be adapted to each different business environment.

The FDA Compliance Enforcement Process
David L Chesney
90 Min
Product Id: 704913
This 90 mins webinar will provide a thorough understanding of the range of FDA enforcement options and the criteria the agency applies in deciding which to use.

Customs Penalties: 19 USC 1592: Avoiding the Impact of a Claim of Commercial Fraud or Negligence
Raymond Sullivan
60 Min
Product Id: 704874
This webinar explains custom penalties - 19 USC 1592 and the elements of violations. The instructor will discuss how to respond to a CBP summons, mitigation procedures and customs’ response. Learn about effect of “prior disclosure” and litigation of 19 USC 1592 claims in the Court of International Trade.

eLabeling for Medical Devices: Valuable but not easy
Daphne Walmer
90 Min
Product Id: 704912
This webinar will explore the benefits of internet-based manuals/IFUs (instructions for use), as well as the products that are eligible to replace paper manuals with internet-based manuals, along with the compliance and business requirements for implementing eLabeling.

Auditing Physician Contracts Under the New 2016 Stark Rules
Joseph Wolfe
60 Min
Product Id: 704384
This training program will provide a general Stark Law overview and explain the requirements for compliance with key regulatory exceptions. The program will also summarize the upcoming changes to the Stark Law for 2016.

Excel Error Functions: IFNA, IFERROR, ISERROR, and More
David H Ringstrom
75 Min
Product Id: 704582
This Excel training program will help participants identify formula errors such as #VALUE!, #REF!, #N/A. Participants will also learn to apply Excel’s Filter feature to quickly scan a column for # sign errors and understand when to use ISERROR or ISNA instead of the IFERROR function. The program will also help recall how to bring Excel’s green error-checking prompts under control.

Integrating ISO 14971 Risk Analysis into the Product Development Process
Russell Pizzuto
90 Min
Product Id: 704926
This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.

Veterinary Medicine and the DEA Due Diligence Requirement for Dispensing and Prescribing a Controlled Substance
Carlos M Aquino
60 Min
Product Id: 704892
This webinar will discuss federal laws and regulations covering all veterinarians who dispense and prescribe controlled substances, record-keeping requirements, penalties for non-compliance and the DEA due diligence required.

A to Z of Supply Chain Management
Danielle DeLucy
60 Min
Product Id: 704917
This webinar will provide complete view on supply chain management. You will learn how to manage supply chain risk, creating opportunities in an Integrated supply chain, how supply chain decisions impact strategy, how to measure supply chain and vendor success.

Sanitation and Chemical Safety Training for Food Manufacturing
Melinda Allen
60 Min
Product Id: 702515
The objective of the webinar is to present you with all-inclusive information on sanitation and chemical safety for food manufacturing. This webinar will provide detailed training which in-turn will benefit all team members who are involved in plant cleaning and sanitation.

The New EU Clinical Trial Regulation
Robert J Russell
90 Min
Product Id: 703758
This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.

Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)
Peggy Berry
90 Min
Product Id: 704882
This webinar will discuss approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in the Drug Master File – in support of Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.

How to Use Big Data for an AML/AB&C Compliance and Risk Mitigation
Shaun Miller
120 Min
Product Id: 704779
This webinar discuss how big data is used for AML compliance review. The instructor will explain how an unstructured data, becomes structured and is subjected to data quality review, sampling and subsequent forensic analysis. The instructor will share how this analysis influences strategic decision in terms of risk mitigation and AML Program enhancement.

USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP
Gregory Martin
90 Min
Product Id: 703521
This webinar will provide insight into some of the hottest topics at USP which will have the greatest impact on pharmaceutical laboratories. It will provide a comprehensive overview of the major changes in the USP that have been proposed or implemented in the last year and describe strategies for keeping abreast of coming changes and how you can influence them.

Developing and Using HR Audit Tools
Ronald Adler
90 Min
Product Id: 702329
This Webinar will discuss the development and use of HR audit tools. The session will cover critical HR audit issues reviewed including indentifying HR audit stakeholders, assessing HR audit areas, developing an HR audit plan, designing HR audit tools, and developing an HR audit scorecard.

Effective Annual U.S. FDA CGMP Training
John E Lincoln
60 Min
Product Id: 701136
This FDA Compliance training will be helped to see how to develop, maintain and improve on a compliant CGMP Employee Training Program for their particular company, product line, and culture.

Essentials of Taxing and Reporting Insurance Benefits for 2016 and Beyond
Vicki M. Lambert
90 Min
Product Id: 704870
This webinar covers the basics of handling insurances in the payroll department including reviewing the requirements under the ACA for the 2016 reporting of health insurance. The Instructor will cover how to handle health insurance plans such as HSAs or HRAs, taxing and reporting life insurance and third party sick pay. He will also explain the role payroll plays in workers’ compensation pay-outs and premium payments.