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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
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
CD/Recorded
$229
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Recorded/CD
Interdisciplinary Bedside Rounds: The State of the Art

Interdisciplinary Bedside Rounds: The State of the Art

  • Speaker: Toni Cesta
  • Product ID: 705237
  • Duration: 60 Min
This webinar will identify the key stakeholders needed for effective interdisciplinary rounds. It will review the best practice rounding processes including scripting and time management.
CD/Recorded
$249
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Recorded/CD
Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

  • Speaker: William Mack Copeland
  • Product ID: 704950
  • Duration: 90 Min
This webinar will provide an in-depth understanding of the Federal False Claims Act, Federal Anti-Kickback and Stark laws, and discuss how marketing activities can trigger either or both.
CD/Recorded
$299
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Recorded/CD
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
CD/Recorded
$299
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Recorded/CD
IT Auditing - Principles and Practices for Executives and Directors

IT Auditing - Principles and Practices for Executives and Directors

  • Speaker: Robert Davis
  • Product ID: 702560
  • Duration: 60 Min
This IT Audit webinar facilitates an executive-level understanding of the ISACA IT Auditing Standards associated with performing IT assurance services and accepted areas of risk for most organizations through exposure to The Davis Adaptive IT Auditing System and Governance Tree frameworks. Webinar presents guidance following the general structure of planning, studying, testing, reporting, and follow-up. This structure can be applied broadly, or narrowly, defined IT audits.
CD/Recorded
$199
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Recorded/CD
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.
CD/Recorded
$229
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Recorded/CD
How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

  • Speaker: Carlos M Aquino
  • Product ID: 705164
  • Duration: 90 Min
This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.
CD/Recorded
$299
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Recorded/CD
Healthcare Fraud Webinar - False Claims, Stark, Anti-Kickback Statute, and Civil Monetary Penalties Law

Healthcare Fraud Webinar - False Claims, Stark, Anti-Kickback Statute, and Civil Monetary Penalties Law

  • Speaker: William Mack Copeland
  • Product ID: 703413
  • Duration: 60 Min
This webinar will explain the Civil Monetary Penalties Law (CMP) and its mandatory and permissive exclusions and penalties. It will also cover obligations under EMTALA, violations of the Anti-Kickback Statute and Stark including amendments under the PPACA.
CD/Recorded
$229
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Recorded/CD
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

  • Speaker: Charity Ogunsanya
  • Product ID: 703875
  • Duration: 90 Min
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
CD/Recorded
$299
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Recorded/CD
An Update on Discharge Planning Rules and Regulations for 2022

An Update on Discharge Planning Rules and Regulations for 2022

  • Speaker: Toni Cesta
  • Product ID: 705120
  • Duration: 60 Min

In this program we will start by reviewing the current rules for discharge planning. Are you compliant with these rules? The newly enacted rules that are now required under the Medicare program’s conditions of participation will be reviewed as they may have a profound effect on how case management departments organize their work. Family caregivers and physicians are expected to be much more involved than they have in the past. This program will review the current rules and regulations from the Conditions of Participation (CoP) for Discharge Planning.

Be sure you know the old rules and the new rules so that your practice will be current and legal! We will review strategies for integrating these requirements into your daily practice.

CD/Recorded
$249
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Recorded/CD
HIPAA Breach Evaluation and Reporting - What Qualifies as a Reportable Breach and how to Report It

HIPAA Breach Evaluation and Reporting - What Qualifies as a Reportable Breach and how to Report It

  • Speaker: Jim Sheldon-Dean
  • Product ID: 705214
  • Duration: 90 Min
There are several steps that must be taken to determine if an incident is a breach, and whether or not that breach is reportable. Determining whether to report or not is not necessarily straightforward, but there are guidelines to follow to help at every step of the way. If the evaluation of necessity to report is not done correctly, you may not make the right decisions about reporting and be subject to penalties for non-compliance upon an investigation of a breach by HHS. Penalties for non-compliance can up to millions of dollars in cases of willful negligence, so it is essential to evaluate incidents to see if they are reportable breaches, and act properly on the evaluation.
CD/Recorded
$249
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Recorded/CD
How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

  • Speaker: Carlos M Aquino
  • Product ID: 704617
  • Duration: 90 Min
The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
CD/Recorded
$299
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Recorded/CD
CGMP controlled Raw Materials

CGMP controlled Raw Materials

  • Speaker: Charity Ogunsanya
  • Product ID: 705148
  • Duration: 90 Min
This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
CD/Recorded
$229
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Recorded/CD
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
CD/Recorded
$299
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Recorded/CD
Best Practice Case Management Roles and Functions: How to Optimize RN and Social Worker Skill Sets

Best Practice Case Management Roles and Functions: How to Optimize RN and Social Worker Skill Sets

  • Speaker: Toni Cesta
  • Product ID: 705419
  • Duration: 60 Min
This webinar will discuss the standards of practice defined for social worker and nurse case managers and how it is applied to the contemporary roles and in turn how it can be applied to the everyday functions and activities social workers and nurses perform to complete their job. It will cover the various roles such as Patient flow, utilization & resource management, denial management, variance tracking, Transitional and discharge planning, Quality Management, Psychosocial assessment and counseling.
CD/Recorded
$249
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Recorded/CD
How to Survive a DEA Inspection - Veterinary Medicine and Controlled Substances

How to Survive a DEA Inspection - Veterinary Medicine and Controlled Substances

  • Speaker: Carlos M Aquino
  • Product ID: 704885
  • Duration: 90 Min
This webinar will discuss federal laws on administering and dispensing veterinary medicine, penalties for non-compliance, DEA required records and effective methods to prevent unauthorized use of controlled substances.
CD/Recorded
$249
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Recorded/CD
How to Conduct Successful Supplier Audits

How to Conduct Successful Supplier Audits

  • Speaker: Danielle DeLucy
  • Product ID: 704499
  • Duration: 60 Min
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.
CD/Recorded
$249
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Recorded/CD
Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations

Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations

  • Speaker: Travis Austin MacKay
  • Product ID: 705497
  • Duration: 60 Min
This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.
CD/Recorded
$279
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Recorded/CD
Root Cause Analysis - The Heart of Corrective Action

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
CD/Recorded
$299
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Recorded/CD
HIPAA and Business Associates - New Responsibilities and Obligations

HIPAA and Business Associates - New Responsibilities and Obligations

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702610
  • Duration: 90 Min
HIPAA regulations pertaining to the relationships of business entities that share PHI are now being enforced. HIPAA Business Associates are covered directly under the Privacy Rule’s use and disclosure limitations, the Security Rule’s safeguard provisions, and the Breach Notification Rule’s notification requirements. HIPAA Business Associates are responsible for their own compliance with the regulations, and may be held directly liable for any violations of the regulations. Whether your organization is a Business Associate or a Covered Entity that hires HIPAA Business Associates, you have significant obligations in compliance that you overlook at your peril.
CD/Recorded
$249
View Details
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