WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA

webinar-speaker   James Russell

webinar-time   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.

Recording Available

* Per Attendee $299

 

3-hr Virtual Seminar: The Psychology (and Law) of Harassment Investigations

webinar-speaker   Dr. Joni E Johnston

webinar-time   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.

Recording Available

* Per Attendee $299

 

Verification and Validation (V&V) of Software in the Medical Devices

webinar-speaker   Dev Raheja

webinar-time   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.

Recording Available

* Per Attendee $149

 

Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management

webinar-speaker   Charles R. McConachie

webinar-time   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.

Recording Available

* Per Attendee $229

 

Device Corrections and Removals

webinar-speaker   Daniel O Leary

webinar-time   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.

Recording Available

* Per Attendee $229

 

Risk-Based Equipment Validation

webinar-speaker   Richard Poser(PhD)

webinar-time   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.

Recording Available

* Per Attendee $229

 

What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?

webinar-speaker   Ornat katzir

webinar-time   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.

Recording Available

* Per Attendee $149

 

21 CFR Part 11 compliance for Electronic Medical Records

webinar-speaker   Alfonso Fuller

webinar-time   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.

Recording Available

* Per Attendee $229

 

HIPAA Breach Notification: Avoiding the fines and costs of healthcare information breaches and what to do when you have a breach

webinar-speaker   Jim Sheldon-Dean

webinar-time   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.

Recording Available

* Per Attendee $229

 

Election Year Legal and Compliance 2012

webinar-speaker   Michael Bayes ,Jason Torchinsky

webinar-time   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.

Recording Available

* Per Attendee $149

 

3-hr Virtual Seminar - Affirmative Action Compliance and Your Recruiting Strategy: Pulling it together

webinar-speaker   Cathleen M. Hampton

webinar-time   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.

Recording Available

* Per Attendee $299

 

Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance

webinar-speaker   Dr. Ludwig Huber

webinar-time   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.

Recording Available

* Per Attendee $229

 

Best Practices for Maintaining an IND and IDE Application with FDA

webinar-speaker   Mukesh Kumar

webinar-time   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.

Recording Available

* Per Attendee $229

 

The Top 6 HIPAA Security Issues: Minimizing Risks Related to Portable Devices, Remote Access, Disaster Recovery, Policies and Procedures, Training, and Documentation

webinar-speaker   Jim Sheldon-Dean

webinar-time   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.

Recording Available

* Per Attendee $229

 

Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements?

webinar-speaker   Mark Gardner

webinar-time   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.

Recording Available

* Per Attendee $249

 

How to Organize and Conduct Product Complaint Investigations

webinar-speaker   Charles R. McConachie

webinar-time   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.

Recording Available

* Per Attendee $149

 

Lean Project Management For U.S. FDA-Regulated Industries

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $229

 

Full-day Virtual Seminar: Critical Factors and Complexities in Payroll 201

webinar-speaker   Vicki M. Lambert

webinar-time   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.

Recording Available

* Per Attendee $399

 

3-hr Virtual Seminar: FDA Medical Device Regulation for the Beginner

webinar-speaker   Karl M. Nobert

webinar-time   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.

Recording Available

* Per Attendee $399

 

21CFR Part 11 - Predicate Rules Compliance

webinar-speaker   Alfonso Fuller

webinar-time   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.

Recording Available

* Per Attendee $349

 

 

 

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