ComplianceOnline

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!

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
23
/ Jul
Friday-2021

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

  • Speaker: Laura Brown
  • Product ID: 701947
  • Duration: 60 Min
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
* Per Attendee
$199
Female to Female Hostility @Workplace: All you need to Know
28
/ Jul
Wednesday-2021

Female to Female Hostility @Workplace: All you need to Know

  • Speaker: Dr. Susan Strauss
  • Product ID: 704544
  • Duration: 60 Min
This training program will discuss whether women are more hostile among each other in the workplace. It will discuss sexism and stereotypes in our perceptions of women and men’s bullying, the nexus of bullying and harassment, and the impact of bullying on witnesses.
* Per Attendee
$179
Healthcare Fraud Webinar - False Claims, Stark, Anti-Kickback Statute, and Civil Monetary Penalties Law
28
/ Jul
Wednesday-2021

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.
* Per Attendee
$179
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
29
/ Jul
Thursday-2021

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

  • Speaker: Joy McElroy
  • Product ID: 704086
  • Duration: 120 Min
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
* Per Attendee
$299
Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability
16
/ Aug
Monday-2021

Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability

  • Speaker: Dr. Susan Strauss
  • Product ID: 704699
  • Duration: 75 Min
This training program will list and enumerate relevant laws, regulations and standards required for health equity and patient-centered care of LGBT patients. It will discuss opportunities to collect LGBT–relevant data and information during the healthcare encounter and help chart strategic community outreach efforts to the LGBT population.
* Per Attendee
$199
Good Documentation Guideline (Chapter <1029> USP)
16
/ Aug
Monday-2021

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.
* Per Attendee
$249
FDA's Ambitious Regulation of Social Media
17
/ Aug
Tuesday-2021

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
* Per Attendee
$229
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
17
/ Aug
Tuesday-2021

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.
* Per Attendee
$229
Integrating COBIT with COSO and Other Frameworks
18
/ Aug
Wednesday-2021

Integrating COBIT with COSO and Other Frameworks

  • Speaker: Robert Davis
  • Product ID: 702567
  • Duration: 60 Min
Dr. Davis describes important directions and core principles of selected frameworks. He also links these guidelines and principles to relevant practices. The principles outlined in this session reflect ISACA defined governance system themes: (1) meeting stakeholder needs (2) enterprise end-to-end coverage, (3) organizational customization (4) dynamic homeostasis, (5) enabling a holistic approach, and (6) separating governance from management.
* Per Attendee
$179
Process Validation - Overview of Why and How
18
/ Aug
Wednesday-2021

Process Validation - Overview of Why and How

  • Speaker: Betty Lane
  • Product ID: 703520
  • Duration: 60 Min
This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
* Per Attendee
$199
SaaS/Cloud Risk-Based Validation With Time-Saving Templates
18
/ Aug
Wednesday-2021

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Min
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
* Per Attendee
$249
The Safety Responsibility of the HR Manager | HR and OSHA Laws
19
/ Aug
Thursday-2021

The Safety Responsibility of the HR Manager | HR and OSHA Laws

  • Speaker: Michael Aust
  • Product ID: 704831
  • Duration: 60 Min
This webinar will explain legislative roles and responsibilities of workplace parties and how HR plays a pertinent role in it. Instructor will discuss OSHA regulations and safety compliance practices and how to create safety culture at workplace. He will share practical tips and best practices for HR managers taking the responsibility of safety regulatory compliance.
* Per Attendee
$199
Writing an Effective SAR Narrative
19
/ Aug
Thursday-2021

Writing an Effective SAR Narrative

  • Speaker: Doug Keipper
  • Product ID: 702993
  • Duration: 60 Min
This BSA compliance training on Suspicious Activity Reporting (SAR) will provide details on how to prepare a SAR (Suspicious Activity Reporting) narrative that meets examiner scrutiny and provides necessary detail for law enforcement.
* Per Attendee
$179
Requirements for Running Clinical Trials in Pediatrics for the EU
20
/ Aug
Friday-2021

Requirements for Running Clinical Trials in Pediatrics for the EU

  • Speaker: Laura Brown
  • Product ID: 701983
  • Duration: 60 Min
This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.
* Per Attendee
$199
Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances
23
/ Aug
Monday-2021

Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances

  • Speaker: Michael Brodsky
  • Product ID: 704861
  • Duration: 60 Min
This RCA webinar will define a specific set of steps and associated tools that you can use to determine the primary cause of non-conformance in your laboratory. You will learn to determine what happened, why it happened and how to reduce the likelihood of that non-conformance happening again.
* Per Attendee
$199
Recorded/CD
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

  • Speaker: Roger Cowan
  • Product ID: 703476
  • Duration: 60 Min
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
CD/Recorded
$299
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
$299
Recorded/CD
Zero-Injury Workplace Culture vs. Safety Culture

Zero-Injury Workplace Culture vs. Safety Culture

  • Speaker: Michael Aust
  • Product ID: 704986
  • Duration: 60 Min
Creating a safety culture in the workplace takes time, patience, and is often a multi-year process. This training program will examine how organizations need to transition from the existing zero injury workplace culture to a more safety oriented culture. In the process, it will examine the pros and cons behind each process and also offer best practices to determine whether you are doing it right.
CD/Recorded
$249
Recorded/CD
How to Prepare a Standard Operating Procedure (SOP)?

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
CD/Recorded
$299
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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