Social Networks and Pharmacovigilance: What Will Change?
Marco Anelli
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.
Structuring and Implementing Hospital-Physician Medical Director and Administrative Arrangements: Key Legal Considerations for Health Systems, Hospitals and Medical Groups - Part I
Joseph Wolfe
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.
Dos & Don'ts Related to Information Security and Data Privacy
Marc Perl
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.
Sterilizing Grade and Prefilter
Mark Trotter
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.
FDA Pre-Approval Inspection Readiness: Actionable Steps to Prepare for a BIMO Inspection
Nicole Tesar
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.
Hazwoper Training: Tips to Hazardous Waste Cleanup per OSHA’s Guidance
Sheldon Primus
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.
Using an IQ / OQ / PQ Approach to Validating Medical Device Software
Mercedes Massana
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.
How to Write Error Free and FDA Compliant Procedures
Ginette M Collazo
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.
ISO 14001:2015 - Advanced Overview - Module 2
Michael Aust
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.
How to Bill Medicare for Durable Medical Equipment and Stay Legally Compliant
Gregory J Simms
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.
How to Establish & Review Your Risk Metrics Effectively
Robert Geary
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.
Detecting and Preventing Corporate Card Fraud - Travel and Entertainment Expenses
Chris Doxey
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.
Effective CDISC Clinical Data Acceptance Testing and Compliance
Sunil Gupta
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.
Applying Lean Tools in Healthcare
Samuel Thomas Zidel
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.
Life Science or Non-Life Science - Oh My! FMLA, ADA and Workers' Comp Overlap Guidance for all Employers
Janette Levey Frisch
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.
Process Validation Guidance Requirements, FDA, EU Annex 15; Qualification and Validation
Joy McElroy
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.
5 Steps to Creating a Rock-Solid Recall Plan
Valerie Scheidt
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.
A2Z of ACH - Authorizations, Revocations, and NOCs - Part 2
Rayleen M Pirnie
90 Min
Product Id: 704572
This three-part webinar series is designed specifically for businesses who either currently process ACH credits and/or debits, or those exploring the network for use in the future. Each session will focus on niche areas of ACH essentials. This course in the series will explore ACH authorization requirements, revocations, and Notifications of Change (NOCs) in the ACH network from the perspective of how each affects a business originator.
Title 19 Customs Duties Parts 200 to End, Revisited
Raymond Sullivan
60 Min
Product Id: 704733
This training program will identify trade actions that can impact an importers business and illustrate the critical role of “material injury” in trade proceedings. It will also examine the distinctions between governmental role in trade actions and private resolutions.
Medication Errors: Will the New Requirements Impact Your Processes?
Marco Anelli
90 Min
Product Id: 704717
Medication errors can occur for many reasons at the time of prescribing, dispensing, storing, preparation or administration of a medicine. It is estimated that among hospitalized patients 18.7% to 56% of adverse events are caused by medication errors. This training program will analyze the European Medicines Agency’s (EMA) recently published good practice guide on medication errors to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU.