How to Write a Plan for Correction of Deficiencies and for QAPI
Melissa Abbott
90 Min
Product Id: 705731
This Webinar will discuss how to create a plan for correction of survey deficiencies which includes the incorporation of the agencies Quality Assurance Performance Improvement indicators to ensure ongoing compliance. A focus will be on plan of corrections for the new Conditions of Participation that were implemented on January 13, 2018.
Laboratory Investigations for Out of Specification Results
Barbara Berglund
90 Min
Product Id: 702263
This 90-minute webinar on laboratory investigations will explore successful approaches to laboratory investigations of out of trend results and also explore approaches which may have potential for pitfalls.
Sunshine Act Reporting: Clarification for Clinical Research
Danielle DeLucy
60 Min
Product Id: 705747
This Sunshine Act reporting webinar will discuss new requirements for manufacturers of healthcare products related to report of certain payments and items of value given to physicians and teaching hospitals. It will discuss the reporting format, exemptions and timeline for compliance and practical solutions to most common situations prevalent between sponsors and investigators.
Understanding Disinfectant Qualification Studies - How to avoid errors
Jim Polarine
90 Min
Product Id: 702210
This 90-minute webinar on Disinfectant Qualification Studies will teach you disinfectant testing methodologies, provide examples of disinfectant efficacy tests and show how to troubleshoot problems related to disinfectant efficacy testing.
The New CBP Enforcement Direction
Raymond Sullivan
60 Min
Product Id: 705711
This CBP webinar will discuss the general compliance requirements, the likelihood of a CBP inquiry and how to identify potential vulnerability by conducting internal review, testing your compliance and most importantly what to do when targeted by CBP.
Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?
Peggy Berry
60 Min
Product Id: 705349
This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.
Effective Compensation System: Creating a Sensible Base Pay System that Doesn't Backfire
Wes Pruett
60 Min
Product Id: 705516
This webinar will discuss the fundamentals of current base pay plan, market pricing, compa-ratio, grades, and ranges to give your organization the means to confidently build a competitive and effective pay structure.
CMS New Requirements of Participation - Phase 2 : Do you know what is required?
Carmen Bowman
90 Min
Product Id: 705741
This webinar will be a detailed look at regulations which are in place on Nov. 28, 2017. The new survey process using the new requirements could take place in your nursing home anytime and will be evaluating both Phase 1 and Phase 2 requirements. Be sure you understand the Phase 2 regulations and know where your home stands in complying with them.
Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience
John R Godshalk
60 Min
Product Id: 704806
This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity
Physicians Working with Non-Physician Practitioners – To Bill or Not to Bill
LaTrece Freeman Baker
60 Min
Product Id: 705770
This webinar will unravel the Center for Medicare and Medicaid’s (CMS) guidelines on billing for “incident to” and Split/Shared services and will discuss the many benefits of doing so, while cautioning practices about compliance risks. The audience will be helped to understand the requirements when billing these types of services and to understand the documentation and supervision requirements of the physician.
Excel Pivot Tables 101: 2007, 2010, 2013 and 2016
David H Ringstrom
90 Min
Product Id: 704603
This webinar will help you master pivot tables in Excel 2007, 2010, 2013, and 2016. Learn tricks and traps of working with pivot tables to help ensure accuracy of reports and convert obsolete Excel spreadsheet files to modern workbook formats.
Central Nervous System (CNS) Drugs and Breastfeeding
Frank J Nice
120 Min
Product Id: 705710
This webinar will discuss how to counsel mothers about adverse effects of taking medication while breastfeeding. How to identify CBS drugs that are usually safe to use while breastfeeding.
Internal GMP Audit Program - Execution and Communication
Ronald Torlini
60 Min
Product Id: 705750
This webinar will discuss the steps to execute internal GMP Audit, how to get all departments for acceptance and how to communicate audit findings specifically when it is serious and quality needs confirmation of acceptance and resolution.
Family Medical Leave Statutes for Small and Medium Business
Matthew W Burr
60 Min
Product Id: 705268
This training program will describe the scope, objective and domain of FMLA. It will help identify most frequent types of FMLA abuse and discuss case studies on FMLA abuses. The webinar instructor will also discuss best practices to carry out effective FMLA investigation and highlight documentation guidelines that will help your company stay out of court and avoid settling claims.
Practical Risk Appetite and Risk Tolerance
Mario Mosse
90 Min
Product Id: 704949
This webinar will discuss how to implement and monitor risk policy. The instructor will explain the challenges and opportunities involved in developing and implementing an effective risk appetite statement, which is supported by risk limits, and the determination of actual exposure against those limits and risk tolerance.
How to Conduct a HIPAA Risk Assessment
Brian Tuttle
60 Min
Product Id: 704592
This training program will cover the proper methodologies of conducting a HIPAA risk assessment based on the formula used by federal auditors and based on the NIST (National Institute of Standard for Technologies) guidelines. The session will also cover the most important aspects to be aware of in terms of the federal auditing process as well as the new risks regarding patients suing for wrongful disclosures.
Patients Suing Under HIPAA
Brian Tuttle
60 Min
Product Id: 704387
This training program will be addressing major changes under the Omnibus Rule which give patients the right to sue under state law citing HIPAA. There are enormous issues and risks for covered entities and business associates under Omnibus.
Understanding the Brazilian Regulatory Environment for Medical Devices
Claudia Thereza de Lucca Mano
60 Min
Product Id: 705721
This webinar will discuss current medical device registration requirements in Brazil and recent regulatory changes. Topics to be discussed are Company Licensing, risk assessment, how to get regulatory clearance,GMP certification, INMETRO certification, govt fees etc.
Develop a Compliant Validation Protocol and Analytical Procedures according to the FDA Guidance and USP Good Documentation Practices
Kim Huynh-Ba
90 Min
Product Id: 705740
This Method validation protocol training will discuss the regulatory requirements of analytical test methods, the USP good documentation practices <1029> and how to establish acceptance criteria for validation.
Understanding the new revision of USP chapter 1058: Analytical Instrument Qualification
Dr. Ludwig Huber
75 Min
Product Id: 705723
This webinar will discuss the new content of revised USP chapter 1058, will compare with the old version and discuss how to implement it. The approaches for risk based qualification, instrument lifecycle, quality agreements, how to integrate software validation and equipment qualification, how to integrate with GAMP Guide on Laboratory Computerized Systems.







