WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Drug Master Files: New Requirements under GDUFA

webinar-speaker   Camille Davis Thornton

webinar-time   60 Min

Product Id: 703209

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.

Recording Available

* Per Attendee $229

 

Building an Effective Contractor Management Program

webinar-speaker   Styron Powers

webinar-time   60 Min

Product Id: 703204

This training will provide the attendees tools and techniques for developing and implementing an effective Contractor Management Program.

Recording Available

* Per Attendee $149

 

Navigating and Negotiating HIPAA Business Associate Agreements

webinar-speaker   Amy Fehn

webinar-time   60 Min

Product Id: 703208

This training on HIPAA compliance will discuss the modifications made to the Final Omnibus Rule and the impact of these changes on agreements between covered entities and business associates. Attendees will learn best practices for developing and negotiating new business associate agreements.

Recording Available

* Per Attendee $229

 

Complying with Regional Trade Agreements (RTAs) to Expand Internationally

webinar-speaker   Andrea Ewart

webinar-time   90 Min

Product Id: 703228

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.

Recording Available

* Per Attendee $149

 

An Approach to Validating Allergen Cleaning Procedures

webinar-speaker   Ian Ramsay

webinar-time   60 Min

Product Id: 702685

This training on allergen cleaning will cover a rigorous approach to validating cleaning procedures or where cleaning is not possible supporting the need for a ‘may contain’ claim.

Recording Available

* Per Attendee $229

 

6,379 Covered Entity Social Media Sites and Counting: what to know and do before you join the list

webinar-speaker   Paul Frisch

webinar-time   90 Min

Product Id: 703173

This webinar on the use of social media by covered entities will discuss the risks, compliance requirements, the effective policies and procedures that you should have in place when using social media.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Mark J Alexander

webinar-time   60 Min

Product Id: 703103

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.

Recording Available

* Per Attendee $149

 

FDA's Oversight of Mobile Medical Applications (''apps'') for Use on Smartphones and Similar Mobile Devices

webinar-speaker   Karl M. Nobert

webinar-time   90 Min

Product Id: 702270

This training on FDA regulation of mobile medical applications is designed to provide attendees with an overview of the U.S. Food and Drug Administration's oversight of certain medical and healthcare mobile medical applications ("apps") designed for use on smartphones and other mobile computing devices. Attendees will learn to distinguish between those apps requiring FDA review and those not subject to regulatory oversight.

Recording Available

* Per Attendee $229

 

Documenting Performance and Administrating Progressive Discipline

webinar-speaker   Marna Hayden

webinar-time   60 Min

Product Id: 702978

This HR compliance training will discuss the methods for implementing effective discipline policies and setting performance improvement plans in the workplace. It will also provide tools and best practices for communicating standards of conduct and performance tracking and documentation process.

Recording Available

* Per Attendee $199

 

Evaluating your Ethics and Compliance Program for Effectiveness: A Checklist and the Business Case

webinar-speaker   Andrea Bonime Blanc

webinar-time   60 Min

Product Id: 702980

This corporate ethics and compliance training will provide you a framework for the evaluation of the effectiveness of your organizational ethics and compliance program. It will help you understand the importance and role of periodic evaluation in order to ensure compliance and avoid lawsuits.

Recording Available

* Per Attendee $149

 

Commanding Grey Areas in ''Deemed Exports and Re-Exports'' and Transfers of Know- How

webinar-speaker   Suzanne Bullitt

webinar-time   60 Min

Product Id: 703199

This webinar about Commanding Grey Areas in “Deemed Exports and Re-Exports” explores the challenges facing multinational corporations when considering the “Deemed Export” rule and will provide your organization with considerations for strategizing your best practices for “Deemed Exports and Re-exports.”

Recording Available

* Per Attendee $149

 

Walking the Minefield of Clinical Trial Budgets and Contracts; A Primer for Research Managers

webinar-speaker   Robert Romanchuk

webinar-time   90 Min

Product Id: 702373

This webinar will provide a basic understanding of regulations and statutes that people involved in the clinical research contract negotiation process must be aware of. You will learn how to negotiate for and create federally complaint agreements and thus avoid the risk associated with violations.

Recording Available

* Per Attendee $229

 

FSMA Update - Overview Three Sweeping Rules: Foreign Supplier Verification Program Rule, Third Party Auditor Accreditation Rule, Preventive Controls Rule and GMPs for Animal Food/Feed Rule

webinar-speaker   Marc Sanchez

webinar-time   60 Min

Product Id: 703193

This webinar will cover the basic mechanics of new rules under the Food Safety Modernization Act (FSMA); Foreign Supplier Verification Program rule, Third Party Auditor Accreditation rule, Preventive Controls rule and GMPs for Animal Food/Feed rule.

Recording Available

* Per Attendee $229

 

How to Withstand an FDA Audit of your Facility

webinar-speaker   Mukesh Kumar

webinar-time   60 Min

Product Id: 701869

This training on managing FDA audits will discuss practical tips to be prepared for an FDA audit of your facility, the appropriate conduct during an audit and the follow-up activities to an audit. You will learn the Do’s and Don’ts of an FDA inspection to ensure a successful audit.

Recording Available

* Per Attendee $229

 

HIPAA Omnibus Update Rule - What it Means for Security and Breach Compliance

webinar-speaker   Jim Sheldon-Dean

webinar-time   90 Min

Product Id: 703183

This training on HIPAA omnibus rule will focus on the HIPAA Security Rule requirements and the new breach determination requirements in the updated HIPAA Breach Notification Rule, and show how the two are related in a good compliance program. Attendees will also learn best practices to prepare for HIPAA audit.

Recording Available

* Per Attendee $149

 

Class Action Risks in Food Labeling: Changing Regulation, Consumer Litigation

webinar-speaker   J Mason Weeda

webinar-time   60 Min

Product Id: 703184

This webinar will discuss recent consumer class action suits, their evolution and the trends in consumer claims and provide suggestions to help you avoid these types of cases.

Recording Available

* Per Attendee $229

 

The Invisible Workforce - Compliance Issues Regarding Independent Contractors and Interns

webinar-speaker   Jules Halpern

webinar-time   70 Min

Product Id: 703169

This webinar will discuss compliance issues surrounding non-payroll workers such as independent contractors and interns. It will also provide tools and best practices for properly classifying such workers and managing risk when employers have already misclassified their workers.

Recording Available

* Per Attendee $149

 

Understanding the Scope of FDA's Inspection Authority and Its Ability to Access Company Records

webinar-speaker   Frederick Stearns

webinar-time   60 Min

Product Id: 702580

This webinar will discuss the scope of the Food and Drug Administration’s (FDA’s) authority to inspect manufacturers of foods, dietary supplements, cosmetics, pharmaceuticals, and medical devices and the Agency’s ability to access company records. It will also cover the potential impact of the draft guidance document on drug inspections that FDA issued in July 2013.

Recording Available

* Per Attendee $229

 

''Knowing Your Customers'' - Navigating US End User Requirements

webinar-speaker   Suzanne Bullitt

webinar-time   60 Min

Product Id: 703190

This training will provide a regulatory overview of US end-user concerns and will provide guidance on conducting end user reviews for US export and re-export transactions.

Recording Available

* Per Attendee $149

 

Top 10 FMLA/ADA Mistakes Managers Make

webinar-speaker   Melissa Fleischer

webinar-time   60 Min

Product Id: 703189

This in-depth webinar will provide the answers to all your toughest FMLA/ADA questions so that you can ensure compliance with both of these laws. Learn how to comply with the FMLA and ADA so that you will be in full compliance and able to best manage your employees’ leave of absence issues.

Recording Available

* Per Attendee $199

 

 

 

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