Staying Ahead of the OIG: Best Practices in avoiding Fraud and Abuse and Civil Fines and Penalties
Alice H Martin,Michael Rosen
75 Min
Product Id: 703231
This webinar will discuss how to review the OIG Strategic Plan for 2014-2018 and recent cases of enforcement in the area of Fraud and Abuse. This session will cover the best practices and a compliance plan that can help you avoid these pitfalls and penalties.

OSHA Process Safety Management (PSM) compliance directive (CPL) and interpretations review
Bill Greulich
90 Min
Product Id: 702352
This 90-minute webinar will help you understand the application and requirements of OSHA Process Safety Management and the topics that have been interpreted and reviewed in the compliance guidelines.

Is Your Criminal Background Check Policy Consistent with the EEOC's Updated Guidance?
Kevin Troutman
90 Min
Product Id: 703251
This HR compliance training will provide the attendees tools and procedures for adopting the right background check policy to avoid discrimination claims and lawsuits. It will provide an overview of recent cases brought against employers for improper use of criminal background information.

FDA Software Validation Self-Check - plan an effective Internal Audit program
Alfonso Fuller
60 Min
Product Id: 701519
This FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection.

FDA Warning Letter Closeout Program
Alfonso Fuller
60 Min
Product Id: 701521
This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.

Protecting Inexperienced Workers in Hazardous Industries/Tasks
Styron Powers
60 Min
Product Id: 703207
This training on health and safety compliance will provide the attendees best practices for protecting new and experienced employees and contractors in hazardous industries.

An Introduction to FDA's Regulation of Over-the-Counter (OTC) Drug Products
Karl M. Nobert
90 Min
Product Id: 702356
This webinar will provide an introduction to the FDA’s regulation of Over-the-Counter (OTC) drug products and the various methods for bringing such a product to market. You will learn the various options for marketing an OTC drug, gain an understanding of FDA’s relevant labeling and promotional rules, and learn strategies for mitigating the potential risk for FDA regulatory enforcement.

Risk Management for Directors and Officers
Dan Swanson
60 Min
Product Id: 702410
This webinar will discuss leading and emerging risk management practices and show how your organization’s risk management capabilities can be improved. It will present proven techniques that you can use to assess and improve your risk management design and operating effectiveness.

Social Media Trends, Best Practices and Compliance for Healthcare Professionals
Janet Kennedy
60 Min
Product Id: 703247
This social media training for healthcare professionals will provide attendees best practices to ensure compliance with social media policies and avoid HIPAA violations and the resulting penalties and lawsuits.

Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.
Karl M. Nobert
90 Min
Product Id: 702508
This training on medical foods will provide an introduction to FDA’s regulation of medical products, assist you in identifying when it may be appropriate to market a product as a medical food; recommend strategies for marketing such products; and summarize recent FDA enforcement actions in the area to help companies mitigate the risk of potential Agency enforcement action.

Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body
Bob Michalik, JD, RAC Michalik
60 Min
Product Id: 700691
This training on legal writing for regulatory submissions will provide practical tips that have proven to enhance the persuasiveness of regulatory submissions and help you succeed even if some of your test results or other supporting information are lacking.

Environmental Monitoring and Contamination Control Plan
Jim Polarine
90 Min
Product Id: 702209
This 90-minute cleanroom contamination control training will review the common mistakes that people make in cleanrooms that lead to contamination, show how to develop a successful contamination control program and discuss ways to improve your facility's design and maintenance.

Risk Factors in EEOC Compliance
Bob McKenzie
60 Min
Product Id: 703224
This training will discuss how to comply with Equal Employment Opportunity Laws, EEOC's investigative tactics and enforcement and what you can do to avoid discrimination charges.

How to Audit the ERM function
Denise Cicchella
60 Min
Product Id: 703240
This training will provide the attendees best practices for auditing the Enterprise Risk Management function. Learn the role and importance of audit in maintaining the effectiveness of ERM program.

Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting
Roger Toothaker
60 Min
Product Id: 703214
This training on FDA compliance will provide the attendees with an understanding of FDA expectations regarding end-of-phase 2A meeting guidance. Attendees will learn the best practices to comply with the intent of the guidance and to achieve a higher quality outcome from the meeting.

Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for My Program
Adam Ruskin
90 Min
Product Id: 703210
This training on clinical compliance will focus on the requirements of trial master file (TMF) for pharmaceutical product, biotech, a medical device or a diagnostic product. Attendees will learn the best practices to ensure that the TMF is ready for inspection by the regulatory authority.

US FDA 510(k): Best Practices for 510(k) Preparation and Submission
David Lim
60 Min
Product Id: 703218
This webinar will discuss best practices for premarket notification [510(k)] preparation and submission compliant with FDA's eCopy and Refuse to Accept (RTA) Policy requirements.

Bacterial Contamination in a Product Facility
Richard Anfuso
60 Min
Product Id: 703217
This training on food safety compliance will provide the attendees with the knowledge of how food borne pathogens enter a food plant, expand its presence within the facility and contaminate the products. Attendees will learn the best practices for minimizing the presence of these pathogens in the food plant.

Clinical Trial Billing - Building a Compliant Process that Works!
Robert Romanchuk
90 Min
Product Id: 702426
This webinar will show how you can devise a clinical trial billing system/ process to manage the billing of clinical trial charges in compliance with Federal rules and regulations.

FDA Warning Letter - Consent Decree Software Validation
Alfonso Fuller
60 Min
Product Id: 701520
This training on FDA software validation related warning letters will discuss what to do to avoid additional software related compliance issues along with the response steps where the citations that directly or indirectly include automated system.