WEBINARS

 

Compliance Training Webinars for Regulated Industries

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When Studies are Exempted from IND Requirements: Understanding the Criteria and the Consequences

webinar-speaker   Jennifer Holcomb

webinar-time   60 Min

Product Id: 702345

This Clinical compliance training will review the purpose of INDs and the process for obtaining an IND. Attendees will gain a complete understanding of the criteria for exemption and the impact an exemption has on a study.

Recording Available

* Per Attendee $229

 

3-Hr Virtual Training: What to Expect in a Federal HIPAA Audit and How to Avoid an Audit Altogether

webinar-speaker   Brian Tuttle

webinar-time   3 hrs

Product Id: 704761

This webinar training will discuss changes with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books and new risks specific to business associates. It will also discuss factors that might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for the audit and deal with federal and state laws.

Recording Available

 

3-hr Virtual Seminar - Trade with Southern Hemisphere: DR-CAFTA (Dominican Republic-Central America)

webinar-speaker   Linda B Sarabia

webinar-time   3 hrs

Product Id: 704715

This training program on CAFTA import and export will detail the US requirements to export and import procedures to CAFTA Nations. It will also discuss commercial and customs document requirements, tariffs and applicable duties, countervailing and antidumping duties, and highlight the difference and interaction between CAFTA and NAFTA.

Recording Available

 

Social Networks and Pharmacovigilance: What Will Change?

webinar-speaker   Marco Anelli

webinar-time   90 Min

Product Id: 704690

This training program will examine the different types of social networks (Facebook, Twitter, etc.) and help identify similarities, differences, and challenges for pharmacovigilance (PV) professionals. It will also analyze social networks and the new approach to benefit/risk ratio.

Recording Available

 

Structuring and Implementing Hospital-Physician Medical Director and Administrative Arrangements: Key Legal Considerations for Health Systems, Hospitals and Medical Groups - Part I

webinar-speaker   Joseph Wolfe

webinar-time   60 Min

Product Id: 704742

Given the substantial awards and settlements in recent enforcement actions, Stark Law compliance has become more than just a compliance issue: it is an enterprise risk management issue. As medical groups, hospitals, and health systems transition to more innovative compensation structures, this training program will focus on managing compliance and enterprise risk by ensuring their medical director and administrative arrangements are defensible under the Stark Law.

Recording Available

* Per Attendee $179

 

Dos & Don'ts Related to Information Security and Data Privacy

webinar-speaker   Marc Perl

webinar-time   60 Min

Product Id: 704736

This training program will prepare your organization to understand the need for data security, the steps that can be taken to institute or augment your data security policies/procedures, and the implementation of the needed controls. This webinar will introduce attendees to a set of known and respected data security standards that can be employed by your organization to improve your security. Attendees will walk away with ideas to leverage the curriculum with their existing security infrastructure.

Recording Available

* Per Attendee $249

 

Sterilizing Grade and Prefilter

webinar-speaker   Mark Trotter

webinar-time   90 Min

Product Id: 704703

This training program will review the latest industry filtration technologies and standards with an overview of regulatory requirements. It will also discuss why and how to determine which filter, the media, and pore ratings that are appropriate for various filtration applications. The program is designed for experienced as well as those new to biopharmaceutical processes. The need-to-know current requirements for specifying sterilizing grade and prefilters in biopharm processes will also be discussed.

Recording Available

 

FDA Pre-Approval Inspection Readiness: Actionable Steps to Prepare for a BIMO Inspection

webinar-speaker   Nicole Tesar

webinar-time   60 Min

Product Id: 704640

This 60-minute training program is designed for those working in the field of clinical research either as a sponsor (pharmaceutical/biotech company) or a research site. The session will discuss key FDA inspection terminology, types of BIMO inspections, site inspection procedures, and sponsor inspection procedures. Attendees will understand when an inspection is likely to be scheduled and the current trends in findings.

Recording Available

 

Hazwoper Training: Tips to Hazardous Waste Cleanup per OSHA’s Guidance

webinar-speaker   Sheldon Primus

webinar-time   60 Min

Product Id: 704602

This training program will focus on helping attendees identify the hazards of chemical spill cleanup, understand the steps to properly clean up hazardous chemical spills, and gain a basic knowledge of the Resource Conservation and Recovery Act and Process Safety Management.

Recording Available

 

Using an IQ / OQ / PQ Approach to Validating Medical Device Software

webinar-speaker   Mercedes Massana

webinar-time   60 Min

Product Id: 702117

This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation.

Recording Available

* Per Attendee $229

 

How to Write Error Free and FDA Compliant Procedures

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704122

This training program will focus on the importance of procedures. Attendees will learn why people avoid procedures and understand common human errors and deviations related to the use of procedures.

Recording Available

* Per Attendee $249

 

ISO 14001:2015 - Advanced Overview - Module 2

webinar-speaker   Michael Aust

webinar-time   60 Min

Product Id: 704728

ISO 14001 is the world's best-known environmental management system standard, and it provides a systematic framework to help organizations protect the environment through balanced socio-economic means. This training program in the two-part series will offer an advanced overview of ISO 14001:2015 and what the updates mean for your business.

Recording Available

 

How to Bill Medicare for Durable Medical Equipment and Stay Legally Compliant

webinar-speaker   Gregory J Simms

webinar-time   60 Min

Product Id: 702134

This training program will expound on how treating your Medicare patients with durable medical equipment (DME) can be great for patient clinical outcomes, a great revenue stream, and can be legally compliant. It will also lower healthcare costs. However, one must know how to get the proper licensure and know the federal and state guidelines.

Recording Available

* Per Attendee $50

 

How to Establish & Review Your Risk Metrics Effectively

webinar-speaker   Robert Geary

webinar-time   90 Min

Product Id: 704709

This webinar training provides an in depth understanding and applicability of the risk metrics. The instructor helps in establishing the purpose they serve and reviewing the methodology for creating a set of risk metrics. He will also discuss the sampling of forms of risk metrics to be employed and review the risk metric management process.

Recording Available

 

Detecting and Preventing Corporate Card Fraud - Travel and Entertainment Expenses

webinar-speaker   Chris Doxey

webinar-time   90 Min

Product Id: 704707

This webcast will discuss the policies, procedures, and controls that will help your company detect and prevent corporate card fraud. The Instructor will discuss the type of corporate credit cards and best practices for developing your travel and entertainment expense (T&E) policy. Participants will learn the T&E standards of internal control and how to automate their T&E Process.

Recording Available

* Per Attendee $179

 

Effective CDISC Clinical Data Acceptance Testing and Compliance

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704687

This CDISC training program will enumerate clinical data issues, effective methods and SAS macros to identify data issues, and communicating and monitoring improvements in clinical data issues.

Recording Available

 

Applying Lean Tools in Healthcare

webinar-speaker   Samuel Thomas Zidel

webinar-time   60 Min

Product Id: 704681

This training program will discuss why traditional manufacturing implementation methods do not result in sustainable gains in a healthcare environment. Attendees will learn how to use and properly apply Lean tools in a healthcare setting.

Recording Available

 

Life Science or Non-Life Science - Oh My! FMLA, ADA and Workers' Comp Overlap Guidance for all Employers

webinar-speaker   Janette Levey Frisch

webinar-time   120 Min

Product Id: 704344

This training program will analyze these three seemingly different bodies of law that often overlap leading to ambiguity and confusion. What are the eligibility/coverage criteria under the FMLA and the ADA/ADAAA and workers comp? When might an extended leave be a reasonable accommodation? When might it be an undue hardship? Undue hardship can mean different things to different employers. If you are in healthcare, pharma, banking and finance, to name a few examples, accommodations of leave requests that may be feasible for many other employers, might, for you, be an undue hardship. If it’s not deemed an undue hardship are there steps you can take to mitigate the burden? What are the notice requirements? In this webinar, participants will get answers to these and many other questions.

Recording Available

* Per Attendee $249

 

Process Validation Guidance Requirements, FDA, EU Annex 15; Qualification and Validation

webinar-speaker   Joy McElroy

webinar-time   4 hrs

Product Id: 704737

This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.

Recording Available

 

5 Steps to Creating a Rock-Solid Recall Plan

webinar-speaker   Valerie Scheidt

webinar-time   60 Min

Product Id: 704720

This training session is designed for food safety practitioners who are preparing for implementation of the Preventive Controls rule, and require assistance in effectively developing a recall plan. Those who have an existing product recall and crisis management program understand that identification of the issue is only the first step in controlling the problem. Operations which have formally relied upon the standards as set forth by certification bodies may wish to reconsider their approach based upon the finalization of the PC Rule.

Recording Available

 

 

 

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