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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
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts

Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts

  • Speaker: Angela Bazigos
  • Product ID: 703738
  • Duration: 90 Min
This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.
CD/Recorded
$199
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Recorded/CD
Risk Based Approach in cGMP - Quality Risk Management (QRM)

Risk Based Approach in cGMP - Quality Risk Management (QRM)

  • Speaker: Shana Dressel
  • Product ID: 705412
  • Duration: 60 Min
This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.
CD/Recorded
$0
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Recorded/CD
The Case Management Leader's Role in Auditing for Compliance: How to Know What You Don't Know?

The Case Management Leader's Role in Auditing for Compliance: How to Know What You Don't Know?

  • Speaker: Bev Cunningham
  • Product ID: 705460
  • Duration: 60 Min

The webinar will focus on critical rules and regulations that are applicable to the case management department, optimal processes to meet these regulations and the auditing procedure to obtain results for meeting them.

It will assist the case management department leader(s) in identifying required elements of compliance that must be measured. Critical compliance metrics which must be audited and reported to the appropriate staff member or group(s) will be identified.
CD/Recorded
$0
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Recorded/CD
Employment Contracts Outside the United States

Employment Contracts Outside the United States

  • Speaker: Matthew W Burr
  • Product ID: 705381
  • Duration: 60 Min
This webinar on Employment Contracts Outside the United States furnishes you with answers to everything you need to know about contracts. It will also discuss several key factors such as concerns with these contracts, when to seek guidance, and variation in contracts.
CD/Recorded
$229
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Recorded/CD
FDA Inspections: What Regulations Expect

FDA Inspections: What Regulations Expect

  • Speaker: Joy McElroy
  • Product ID: 705346
  • Duration: 90 Min
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
CD/Recorded
$179
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Recorded/CD
HIPAA Compliance for Dental Practices

HIPAA Compliance for Dental Practices

  • Speaker: Jay Hodes
  • Product ID: 705236
  • Duration: 90 Min
This webinar will provide a detail understanding on HIPAA Security & Privacy Rules and its entire HIPAA compliance process; from the start to ongoing requirements for dental practices. On completion of this training, attendees will learn how to create a culture of compliance in your dental practices.
CD/Recorded
$0
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Recorded/CD
ADA Obligations: Disability Discrimination and Reasonable Accommodation

ADA Obligations: Disability Discrimination and Reasonable Accommodation

  • Speaker: Judith Bevis Langevin
  • Product ID: 705464
  • Duration: 60 Min
Learn the basics of ADA compliance, receive practical guidance on the disability discrimination issues most likely to create workplace issues, and identify resources you can use when ADA problems arise.
CD/Recorded
$0
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Recorded/CD
Pharmacokinetics of Oral Absorption

Pharmacokinetics of Oral Absorption

  • Speaker: Leon Shargel
  • Product ID: 705458
  • Duration: 90 Min
This webinar will discuss pharmacokinetic principles of systemic drug absorption and its applications to the development of oral dosage forms. It will also provide practical examples to show how pharmacokinetics of oral absorption can be applied to drug product development.
CD/Recorded
$0
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Recorded/CD
Employer Information Report/EEO-1: What You Need to Know Before 2018?

Employer Information Report/EEO-1: What You Need to Know Before 2018?

  • Speaker: U Harold Levy
  • Product ID: 705445
  • Duration: 60 Min
This webinar will cover a step by step basics of filing the EEO-1 report and will discuss EEOC's and OFCCP's change in enforcement. It will also provide practical strategies for complying with confidentiality requirements and how to legally survey and classify employees.
CD/Recorded
$229
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Recorded/CD
The Ever-changing Role of Arbitration Agreements in California

The Ever-changing Role of Arbitration Agreements in California

  • Speaker: Jacquiline M Wagner
  • Product ID: 705415
  • Duration: 60 Min
This webinar will discuss the “savings clause” provision in the Federal Arbitration Act and help you determine whether your arbitration agreement is sound under California law.
CD/Recorded
$0
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Recorded/CD
Title IX, the Clery Act, and OCR: Policies, Practices, Procedures, and the Law in Addressing Sexual Harassment, Sexual Violence, and Gender-Based Harassment in Higher Education

Title IX, the Clery Act, and OCR: Policies, Practices, Procedures, and the Law in Addressing Sexual Harassment, Sexual Violence, and Gender-Based Harassment in Higher Education

  • Speaker: Dr. Susan Strauss
  • Product ID: 705390
  • Duration: 120 Min
Does your campus have a prevention and intervention strategy to deal with sexual violence? Do you ensure that Title IX and the Clery Act laws are adhered to? Might you be at risk to lose federal funding by not abiding by OCR’s Guidance? This webinar provides you with the necessary information to enhance your campus equity culture and minimize the risk of sexual violence and liability.
CD/Recorded
$0
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Recorded/CD
NPP Coding and Reimbursement: Non-Physician Practitioners

NPP Coding and Reimbursement: Non-Physician Practitioners

  • Speaker: Terry Fletcher
  • Product ID: 705286
  • Duration: 60 Min
This webinar will provide an overview of the "incident to" rules for the Non-Physician Practitioners (NPP) and Medicare patients. Also, diagnostic testing rules utilizing NPP's will be discussed with a focus on supervision and reimbursement in the physician's office and hospital setting.
CD/Recorded
$0
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Recorded/CD
Leading Through Downsizing: Layoff Notification and Survivor Communication Best Practices

Leading Through Downsizing: Layoff Notification and Survivor Communication Best Practices

  • Speaker: Mary Gormandy White
  • Product ID: 705397
  • Duration: 60 Min
Learn how to effectively and appropriately structure layoff notification conversations and communicate and lead effectively through a reduction in workforce and beyond.
CD/Recorded
$0
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Recorded/CD
Cybersecurity Policy and Controls Management with Root Cause Analysis (RCA)

Cybersecurity Policy and Controls Management with Root Cause Analysis (RCA)

  • Speaker: William Akel
  • Product ID: 705404
  • Duration: 60 Min
Learn corporate policy definition and assignment with ramifications for both. We'll discuss how to identify and document management review controls, why a fine tuned policy and procedure are critical to business operations and how to obtain the real root cause of cyber security incidents effectively.
CD/Recorded
$0
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Recorded/CD
How to Survive a DEA Inspection Series - Controlled Substances and Hospice Program

How to Survive a DEA Inspection Series - Controlled Substances and Hospice Program

  • Speaker: Carlos M Aquino
  • Product ID: 705388
  • Duration: 90 Min
This webinar will cover federal laws and DEA regulatory requirements for practitioners prescribing Schedules II controlled substances for a patient in a certified Hospice Program and the role of the nurse as an authorized agent of the practitioner.
CD/Recorded
$0
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Recorded/CD
European Filing and Registration Procedures

European Filing and Registration Procedures

  • Speaker: Robert J Russell
  • Product ID: 701261
  • Duration: 90 Min
This Regulatory compliance training is designed to provide an overview of the regulatory environment throughout Europe and will explain how the EU interacts with national regulatory agencies.
CD/Recorded
$249
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Recorded/CD
Data Security for Employers

Data Security for Employers

  • Speaker: Judith Bevis Langevin
  • Product ID: 705457
  • Duration: 60 Min
This webinar will focus on legal requirements related to personally identifiable information (PII) security as well as HR’s critical role in data security. It will also provide practical tips on PII security, vendor management, and planning your data breach response.
CD/Recorded
$0
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Recorded/CD
Managing Leave of Absence

Managing Leave of Absence

  • Speaker: Kristin Robinson
  • Product ID: 705442
  • Duration: 90 Min
This webinar will provide an overview of federal and state leave laws including notification requirements and timelines. It will offer best practices for managing leave of absence including tips to avoid FMLA abuse.
CD/Recorded
$0
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Recorded/CD
California Overtime Laws: Exempt vs. Nonexempt - Ensuring Proper Classification of Employees

California Overtime Laws: Exempt vs. Nonexempt - Ensuring Proper Classification of Employees

  • Speaker: Allen Kato
  • Product ID: 704129
  • Duration: 90 Min
This training program will lay the legal foundation and offer attendees a greater understanding of which California laws govern overtime and minimum wage. The course will also offer guidance in exempt classification, including best practices and practical steps to ensure lawful classifications.
CD/Recorded
$0
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Recorded/CD
ISO 9001 and ISO 13485 Upgrades and Impact on the Industry

ISO 9001 and ISO 13485 Upgrades and Impact on the Industry

  • Speaker: Carmine Jabri
  • Product ID: 705449
  • Duration: 60 Min
This webinar will focus on the recent changes to the ISO 9001 and ISO 13485 quality management system (QMS) standards. Participants will be provided with the tools necessary to help their company plan for the transition to the new editions.
CD/Recorded
$0
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