
Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA
James Russell
90 Min
Product Id: 702357
This 90 minute interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations.

3-hr Virtual Seminar: The Psychology (and Law) of Harassment Investigations
Dr. Joni E Johnston
3 hrs
Product Id: 702557
This training on harassment investigations in the workplace will cover practical steps to conduct effective and legally compliant investigations into harassment, discrimination, or other misconduct allegations/ complaints.

Verification and Validation (V&V) of Software in the Medical Devices
Dev Raheja
90 Min
Product Id: 702320
This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.

Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management
Charles R. McConachie
60 Min
Product Id: 702334
This course will provide necessary information to those in the drug and device manufacturing industries on how to best work with consumers and health professionals regarding off-label claims of relevant drugs and devices that arise from third parties or from the natural progression of social media.

Device Corrections and Removals
Daniel O Leary
90 Min
Product Id: 702291
This 90-minute webinar on device corrections and removals will clarify your obligations for corrections and removals under Part 806 of the FDA regulations.

Risk-Based Equipment Validation
Richard Poser(PhD)
90 Min
Product Id: 701004
This training will provide a practical methodology for creating and applying Risk-Based Equipment Validation. It will show an example of how this process may be integrated into a facility Master Validation Plan.

What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?
Ornat katzir
60 Min
Product Id: 702312
This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.

21 CFR Part 11 compliance for Electronic Medical Records
Alfonso Fuller
60 Min
Product Id: 701217
This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.

HIPAA Breach Notification: Avoiding the fines and costs of healthcare information breaches and what to do when you have a breach
Jim Sheldon-Dean
90 Min
Product Id: 702310
This 90-minute webinar on HIPAA Breach Notification will show how to create an effective breach notification policy for your organization and how to follow through when a breach occurs. You will learn about the kinds of threats that exist for PHI, information security methods you can use to keep breaches from happening, and be in compliance with the HIPAA Security Rule as well.

Election Year Legal and Compliance 2012
Michael Bayes ,Jason Torchinsky
75 Min
Product Id: 702228
This webinar on Federal Campaign Finance Law will assist compliance officers and in-house counsel identify common campaign finance issues faced by corporations and trade associations in major election years.

3-hr Virtual Seminar - Affirmative Action Compliance and Your Recruiting Strategy: Pulling it together
Cathleen M. Hampton
3 hrs
Product Id: 702077
This 3-hr virtual seminar will take a deeper look at your recruiting practice and review the objective for affirmative action as it relates to this function in terms of ensuring compliance. The session also features a discussion about how to make the most of your recruiting technology so that you are prepared to meet the OFCCP’s recently heightened enforcement efforts.

Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance
Dr. Ludwig Huber
75 Min
Product Id: 702303
This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation.

Best Practices for Maintaining an IND and IDE Application with FDA
Mukesh Kumar
60 Min
Product Id: 702254
This webinar on IND and IDE Application management will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.

The Top 6 HIPAA Security Issues: Minimizing Risks Related to Portable Devices, Remote Access, Disaster Recovery, Policies and Procedures, Training, and Documentation
Jim Sheldon-Dean
90 Min
Product Id: 702309
This 90-minute webinar will review the top HIPAA security issues that health information professionals face - encryption and mobile devices, remote access, disaster recovery, policies and procedures, documentation and training - and show what they have to do to mitigate the risks they present.

Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements?
Mark Gardner
120 Min
Product Id: 702275
This 120-minute webinar will cover the new (Federal) Physician Payment Sunshine Act, the topics raised by the proposed rule and existing State sunshine laws. Attendees will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to the relevant authority.

How to Organize and Conduct Product Complaint Investigations
Charles R. McConachie
60 Min
Product Id: 702289
This webinar on product complaint investigations will provide the necessary information to those in food, drug, device, cosmetic and related industries that manufacture and distribute products to consumers on how to best receive, respond, investigate and correct product complaints in the best interests of the firm.

Lean Project Management For U.S. FDA-Regulated Industries
John E Lincoln
90 Min
Product Id: 702276
This 90-minute webinar on Lean Project Management for U.S. FDA Regulated companies will show how you can incorporate basic lean principles for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale, while addressing FDA / CGMP requirements.

Full-day Virtual Seminar: Critical Factors and Complexities in Payroll 201
Vicki M. Lambert
7 hrs
Product Id: 702201
This 7-hr virtual seminar on Payroll 201 provides high-level training on topics critical to the intermediate payroll professional. It will increase your knowledge of payroll procedures and compliance regulations beyond the mere basic skills.

3-hr Virtual Seminar: FDA Medical Device Regulation for the Beginner
Karl M. Nobert
3 hrs
Product Id: 702299
This 3-hr virtual seminar will provide an introduction to FDA’s Regulation of Medical Devices and is intended for the Beginner. It will cover device classification, the device manufacturer’s and/or distributor’s regulatory responsibilities, requirements for labeling and user fees, fda inspections and enforcement.

21CFR Part 11 - Predicate Rules Compliance
Alfonso Fuller
60 Min
Product Id: 701328
This 21CFR Part 11 training will clarify the relationship between predicate rules and 21 CFR part 11 compliance, allowing companies to satisfy FDA with a minimum of effort.