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Home › Online Training ›  Regulatory Affairs

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Hundreds of regulatory affairs specialists each year use ComplianceOnline courses to learn skills and get a clear understanding of specific regulatory requirements needed to succeed in their role. On this page, you will find a broad range of courses specially designed for you. Whether you work in the pharmaceutical, medical device, and equipment, biotechnology, cosmetics, research, or regulatory agencies, or within legal, marketing, and scientific consulting firms, you can get acquainted with the regulatory requirements and guidance for your industry. With the knowledge you gain, you will learn how to apply the regulations in a compliant manner into the actual materials that your company manufactures. You will be in a better position to understand the risks your organization faces. You will get a robust understanding of compliance within the scope of your duties. With the knowledge you gain, you can evaluate current practices and make improvements where necessary. Join them!
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Recorded/CD
Effective CDISC Clinical Data Acceptance Testing and Compliance

Effective CDISC Clinical Data Acceptance Testing and Compliance

  • Speaker: Sunil Gupta
  • Product ID: 704687
  • Duration: 75 Min
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.
CD/Recorded
$0
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Recorded/CD
Applying Lean Tools in Healthcare

Applying Lean Tools in Healthcare

  • Speaker: Samuel Thomas Zidel
  • Product ID: 704681
  • Duration: 60 Min
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.
CD/Recorded
$0
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Recorded/CD
Life Science or Non-Life Science - Oh My! FMLA, ADA and Workers' Comp Overlap Guidance for all Employers

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

  • Speaker: Janette Levey Frisch
  • Product ID: 704344
  • Duration: 120 Min
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.
CD/Recorded
$249
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Recorded/CD
Process Validation Guidance Requirements, FDA, EU Annex 15; Qualification and Validation

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

  • Speaker: Joy McElroy
  • Product ID: 704737
  • Duration: 4 hrs
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.
CD/Recorded
$0
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Recorded/CD
5 Steps to Creating a Rock-Solid Recall Plan

5 Steps to Creating a Rock-Solid Recall Plan

  • Speaker: Valerie Scheidt
  • Product ID: 704720
  • Duration: 60 Min
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.
CD/Recorded
$0
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Recorded/CD
Title 19 Customs Duties Parts 200 to End, Revisited

Title 19 Customs Duties Parts 200 to End, Revisited

  • Speaker: Raymond Sullivan
  • Product ID: 704733
  • Duration: 60 Min
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.
CD/Recorded
$0
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Recorded/CD
Medication Errors: Will the New Requirements Impact Your Processes?

Medication Errors: Will the New Requirements Impact Your Processes?

  • Speaker: Marco Anelli
  • Product ID: 704717
  • Duration: 90 Min
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.
CD/Recorded
$0
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Recorded/CD
Effective Auditing and Monitoring for HIPAA Compliance

Effective Auditing and Monitoring for HIPAA Compliance

  • Speaker: Frank Ruelas
  • Product ID: 704711
  • Duration: 60 Min
The Health Insurance Portability and Accountability Act (HIPAA) rules and regulations clearly state that an impermissible use or disclosure is presumed to be a breach. Therefore, any such incident triggers the required notifications. However, if an organization performs a risk assessment and shows why the incident is not a breach, the required notifications would no longer apply. This training program will illustrate how learning to perform an effective risk assessment can not only reduce the administrative burden of dealing with presumed breaches, but also help an organization meet other criteria such as those that exist in the Office for Civil Rights HIPAA audit protocol.
CD/Recorded
$0
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Recorded/CD
Pricing for Risk in Merchant Payments - Risk Metrics, Reserve Requirements, Pricing Models, Best Interchange Rates, EMV/NFC Guidelines

Pricing for Risk in Merchant Payments - Risk Metrics, Reserve Requirements, Pricing Models, Best Interchange Rates, EMV/NFC Guidelines

  • Speaker: Armen Khachadourian
  • Product ID: 704546
  • Duration: 90 Min
This training program will provide insight into fundamental underwriting and risk management guidelines, determining variables that constitute merchant risk, and on how to assign a dollar value and quantify exposure.
CD/Recorded
$0
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Recorded/CD
How Long Do I Keep my Patient's Medical Record? Disposition of Records and Records Retention, Including Electronic Records

How Long Do I Keep my Patient's Medical Record? Disposition of Records and Records Retention, Including Electronic Records

  • Speaker: Mark R Brengelman
  • Product ID: 704718
  • Duration: 60 Min
This training program will break down the legal and contractual requirements for medical records retention. It will identify what information is mandated to be in a specific health care practitioner’s medical record and discuss facility rules as applied to the individual health care practitioner. The program will also discuss electronic records confidentiality, retention, and disposition.
CD/Recorded
$0
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Recorded/CD
ISO 14001:2015 - Basic Overview - Module 1

ISO 14001:2015 - Basic Overview - Module 1

  • Speaker: Michael Aust
  • Product ID: 704706
  • Duration: 60 Min
This first training program in the two-part series will focus on the basic precepts of ISO 14001:2015. Attendees will gain an understanding of the concepts, principles and interpretation of the ISO 14001:2015 standard. This session will also analyze how the revision will impact your business.
CD/Recorded
$0
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Recorded/CD
Effecting Sound Employment Background Checks - California Style

Effecting Sound Employment Background Checks - California Style

  • Speaker: Jacquiline M Wagner
  • Product ID: 704701
  • Duration: 90 Min
This webinar training navigates the best practices for effective background checks in California. The Instructor will cover laws and common types of background checks and why it is pertinent. Participants will understand the process and dos and don’ts of background checks and how it helps in building the right kind of talent pool.
CD/Recorded
$0
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Recorded/CD
Clinical Documentation Improvement

Clinical Documentation Improvement

  • Speaker: Dorothy Steed
  • Product ID: 703367
  • Duration: 60 Min
Clinical documentation is the cornerstone for all patient medical records: the information ensures optimal patient outcomes and supports research, medical coding and other uses of the medical record. This training program will discuss clinical documentation improvement to ensure its purpose, i.e., to adequately relate the patient’s current and historical conditions and treatments with primary focus placed on situations that affect the current medical encounter. It also supports the provider’s defense should the case become a legal issue.
CD/Recorded
$229
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Recorded/CD
Achieving Research Compliance Through Risk Assessment

Achieving Research Compliance Through Risk Assessment

  • Speaker: Sarah Fowler Dixon
  • Product ID: 704689
  • Duration: 60 Min
This training program will analyze the importance of research risks defined in 21 CFR 50 and 45 CFR 46. It will delve into how research risks affect IRB approval and review based on allowable actions in 21 CFR 50. The program will also discuss the need for indemnification language in consent forms based on risk levels.
CD/Recorded
$0
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Recorded/CD
Conducting Performance Appraisals: A New Paradigm

Conducting Performance Appraisals: A New Paradigm

  • Speaker: Gail Birks
  • Product ID: 704677
  • Duration: 60 Min
This webinar training outlines the best practices of conducting performance appraisals. The instructor will explain how and why to monitor, measure and empower your team’s development and the best tools and scripts to motivate and coach your team. Participants will learn how to negotiate through resistance, build trust, manage team diversity and implement proactive plans during appraisal process.
CD/Recorded
$25
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Recorded/CD
Medical Device Complaints, MDR's and Recalls

Medical Device Complaints, MDR's and Recalls

  • Speaker: John Chapman
  • Product ID: 700196
  • Duration: 60 Min
This training program on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls.
CD/Recorded
$179
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Recorded/CD
Conducting Effective Incident Investigation: Avoid Repeat Incidents

Conducting Effective Incident Investigation: Avoid Repeat Incidents

  • Speaker: Michael Aust
  • Product ID: 704688
  • Duration: 60 Min
This training program will explain how to avoid repeat OSHA violations by implementing an effective incident investigation program. It will describe key elements of an effective incident investigation process and identify practices to not perform during the incident investigation process.
CD/Recorded
$0
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Recorded/CD
A Durable Medical Equipment Revenue Program Every Practice Should Have

A Durable Medical Equipment Revenue Program Every Practice Should Have

  • Speaker: Gregory J Simms
  • Product ID: 704694
  • Duration: 60 Min
This training program on durable medical equipment revenue program for medical practitioners will discuss determining business opportunities and determining a financial ROI and a strategic ROI. It will also discuss how to develop policies, processes and business guidelines to make your program successful.
CD/Recorded
$0
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Recorded/CD
Performing an Effective Risk Assessment of Potential Breaches

Performing an Effective Risk Assessment of Potential Breaches

  • Speaker: Frank Ruelas
  • Product ID: 704682
  • Duration: 60 Min
The Health Insurance Portability and Accountability Act (HIPAA) rules and regulations clearly state that an impermissible use or disclosure is presumed to be a breach. Therefore, any such incident triggers the required notifications. However, if an organization performs a risk assessment and shows why the incident is not a breach, the required notifications would no longer apply. This training program will focus on how to perform an effective risk assessment that can not only reduce the administrative burden of dealing with presumed breaches, but also help an organization meet other criteria such as those that exist in the Office for Civil Rights HIPAA audit protocol.
CD/Recorded
$0
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Recorded/CD
Measuring and Managing Customer Profitability - From Growing Sales to 'Profitable' Sales

Measuring and Managing Customer Profitability - From Growing Sales to 'Profitable' Sales

  • Speaker: Gary Cokins
  • Product ID: 704679
  • Duration: 90 Min
This training program will focus on how to shift the mindset from growing sales to growing profitable sales and to view customers as investments like in a stock portfolio to seek higher ROIs – return on customers (ROC). It will also look at how measuring forward-looking customer lifetime value (CLV) differs from calculating historical customer/consumer profitability for B2C industries.
CD/Recorded
$0
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