WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Risk Management for Directors and Officers

webinar-speaker   Dan Swanson

webinar-time   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.

Recording Available

* Per Attendee $149

 

Social Media Trends, Best Practices and Compliance for Healthcare Professionals

webinar-speaker   Janet Kennedy

webinar-time   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.

Recording Available

* Per Attendee $229

 

Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.

webinar-speaker   Karl M. Nobert

webinar-time   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.

Recording Available

* Per Attendee $229

 

Legal Writing Skills to Prepare for Effective Regulatory Submissions - FDA, EU EMEA and EU Notified Body

webinar-speaker   Bob Michalik, JD, RAC Michalik

webinar-time   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.

Recording Available

* Per Attendee $50

 

Environmental Monitoring and Contamination Control Plan

webinar-speaker   Jim Polarine

webinar-time   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.

Recording Available

* Per Attendee $229

 

Risk Factors in EEOC Compliance

webinar-speaker   Bob McKenzie

webinar-time   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.

Recording Available

* Per Attendee $149

 

How to Audit the ERM function

webinar-speaker   Denise Cicchella

webinar-time   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.

Recording Available

* Per Attendee $149

 

Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

webinar-speaker   Roger Toothaker

webinar-time   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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Adam Ruskin

webinar-time   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.

Recording Available

* Per Attendee $229

 

US FDA 510(k): Best Practices for 510(k) Preparation and Submission

webinar-speaker   David Lim

webinar-time   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.

Recording Available

* Per Attendee $229

 

Bacterial Contamination in a Product Facility

webinar-speaker   Richard Anfuso

webinar-time   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.

Recording Available

* Per Attendee $229

 

Clinical Trial Billing - Building a Compliant Process that Works!

webinar-speaker   Robert Romanchuk

webinar-time   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.

Recording Available

* Per Attendee $50

 

FDA Warning Letter - Consent Decree Software Validation

webinar-speaker   Alfonso Fuller

webinar-time   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.

Recording Available

* Per Attendee $229

 

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

 

 

 

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