
Drug Master Files: New Requirements under GDUFA
Camille Davis Thornton
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.

Building an Effective Contractor Management Program
Styron Powers
60 Min
Product Id: 703204
This training will provide the attendees tools and techniques for developing and implementing an effective Contractor Management Program.

Navigating and Negotiating HIPAA Business Associate Agreements
Amy Fehn
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.

Complying with Regional Trade Agreements (RTAs) to Expand Internationally
Andrea Ewart
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.

An Approach to Validating Allergen Cleaning Procedures
Ian Ramsay
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.

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

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

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

Documenting Performance and Administrating Progressive Discipline
Marna Hayden
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.

Evaluating your Ethics and Compliance Program for Effectiveness: A Checklist and the Business Case
Andrea Bonime Blanc
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.

Commanding Grey Areas in ''Deemed Exports and Re-Exports'' and Transfers of Know- How
Suzanne Bullitt
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.”

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

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
Marc Sanchez
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.

How to Withstand an FDA Audit of your Facility
Mukesh Kumar
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.

HIPAA Omnibus Update Rule - What it Means for Security and Breach Compliance
Jim Sheldon-Dean
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.

Class Action Risks in Food Labeling: Changing Regulation, Consumer Litigation
J Mason Weeda
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.

The Invisible Workforce - Compliance Issues Regarding Independent Contractors and Interns
Jules Halpern
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.

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

''Knowing Your Customers'' - Navigating US End User Requirements
Suzanne Bullitt
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.

Top 10 FMLA/ADA Mistakes Managers Make
Melissa Fleischer
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.