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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
Food Safety and Quality Management - Effective Incident Tracking

Food Safety and Quality Management - Effective Incident Tracking

  • Speaker: Felix Amiri
  • Product ID: 705204
  • Duration: 2.5 hrs
This Food Safety and Quality Management training will provide guidance on methods for conducting effective incident tracking. Attendees will learn how to analyze and utilize incident tracing information and data to the benefit of your food business.
CD/Recorded
$0
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Recorded/CD
Medical Device Cybersecurity Following New FDA Guidance

Medical Device Cybersecurity Following New FDA Guidance

  • Speaker: Edwin Waldbusser
  • Product ID: 705200
  • Duration: 60 Min
This training will discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. Attendees will learn how to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA.
CD/Recorded
$179
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Recorded/CD
Overview of Changes in ISO 13485: 2016

Overview of Changes in ISO 13485: 2016

  • Speaker: Lena Cordie Bancroft
  • Product ID: 704756
  • Duration: 60 Min
This training program will discuss changes from ISO 13485: 2003 to ISO 13485: 2016. Attendees will learn how to apply additional supplier controls and understand how improvement and corrective action clauses are strengthened.
CD/Recorded
$249
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Recorded/CD
Physician Employment Agreements: Items to Consider

Physician Employment Agreements: Items to Consider

  • Speaker: William Mack Copeland
  • Product ID: 705195
  • Duration: 60 Min
This webinar will review the various elements of the physician employment agreement, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understand what is being agreed to. Such items as term and termination, termination for cause, duties of the physician, call, non-compete, and compensation are all items that should be clearly set out in the agreement and fully understood by the parties.
CD/Recorded
$0
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Recorded/CD
Clean Labeling and Natural Food Additives: How to meet consumer demand without compromising functionality, safety, shelf-stability, ethics and regulation

Clean Labeling and Natural Food Additives: How to meet consumer demand without compromising functionality, safety, shelf-stability, ethics and regulation

  • Speaker: Azadeh Namvar
  • Product ID: 705194
  • Duration: 60 Min
This online training will discuss the concept of Clean Labelling. Attendees will learn how to identify the approaches to meet consumer demand without compromising functionality, safety, shelf-stability, ethics and regulation.
CD/Recorded
$0
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Recorded/CD
Preparing Stability Protocols for Development and Commercial Products

Preparing Stability Protocols for Development and Commercial Products

  • Speaker: Peggy Berry
  • Product ID: 704459
  • Duration: 90 Min
This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.
CD/Recorded
$279
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Recorded/CD
Pay Equity Compliance: Know all About Pay Disparity, EEO-1 Reporting, Revised EEOC/OFCCP Legislation and More

Pay Equity Compliance: Know all About Pay Disparity, EEO-1 Reporting, Revised EEOC/OFCCP Legislation and More

  • Speaker: Janette Levey Frisch
  • Product ID: 705191
  • Duration: 90 Min
The Equal Employment Opportunity Commission and the Office of Federal Contract Compliance Programs are stepping up their game and focusing on pay disparities as a form of employment discrimination. This training program will offer attendees an understanding of Title VII, sex discrimination and pay equity to help employers get ahead of the EEOC/OFCCP’s new priority and avert pay discrimination claims.
CD/Recorded
$229
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Recorded/CD
Sharing Information with Family and Friends under HIPAA - What is Permissible or Not

Sharing Information with Family and Friends under HIPAA - What is Permissible or Not

  • Speaker: Jim Sheldon-Dean
  • Product ID: 705173
  • Duration: 90 Min
CD/Recorded
$0
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Recorded/CD
How Create a Value-added cGMP/ISO 13485 Internal/Supplier Auditing System

How Create a Value-added cGMP/ISO 13485 Internal/Supplier Auditing System

  • Speaker: Betty Lane
  • Product ID: 705165
  • Duration: 60 Min
This webinar will cover creating of a value-added an internal and supplier auditing program for compliance to FDA and ISO 13485 internal auditing requirements. It will include how to set up and manage the auditing system, as well as how to conduct audits, and document the results and any nonconformities. It will discuss the value of a good auditing program.
CD/Recorded
$0
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Recorded/CD
Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012

Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012

  • Speaker: Daniel O Leary
  • Product ID: 703752
  • Duration: 90 Min
Medical device manufacturers need systems to implement regulatory requirements (meeting customer requirements and handling regulatory complaints) as well as a business processes to determine customer satisfaction. While the three systems are related, each serves a different purpose. You will learn how to implement a customer satisfaction process to complete theses three important aspects.
CD/Recorded
$0
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Recorded/CD
What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

  • Speaker: Rossano V Gerald
  • Product ID: 705186
  • Duration: 60 Min
When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.
CD/Recorded
$0
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Recorded/CD
Virtual Seminar: Regulatory Modernization in Canada and the US: An Overview of the Key Elements

Virtual Seminar: Regulatory Modernization in Canada and the US: An Overview of the Key Elements

  • Speaker: Felix Amiri
  • Product ID: 705182
  • Duration: 2.5 hrs
This 2.5 hours training will review the key elements of the new food regulations in Canada, the United States and the international marketplace. Get accustomed to new regulatory expectations and be prepared to develop relevant and productive compliance plans.
CD/Recorded
$0
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Recorded/CD
GMP Training Practices to ensure Regulatory Compliance

GMP Training Practices to ensure Regulatory Compliance

  • Speaker: Henry Urbach
  • Product ID: 705077
  • Duration: 90 Min
By attending this webinar, you will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. In this webinar your instructor will share with you what he has learned over the past decade of developing and delivering effective GMP training programs as well as from his 25 plus years of working in the Life Science industries.
CD/Recorded
$0
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Recorded/CD
Comply With OFAC: Cuba Sanctions Regulations

Comply With OFAC: Cuba Sanctions Regulations

  • Speaker: Shaun Miller
  • Product ID: 705101
  • Duration: 90 Min
This training will review Office of Foreign Assets Control (OFAC) and the US Department of Commerce, Bureau of Industry and Security (BIS) respectively amended; the Cuban Assets Control Regulations (CACR) and the Export Administration Regulations (EAR) to further ease the US embargo against Cuba and authorize certain business activities with Cuba in targeted sectors.
CD/Recorded
$199
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Recorded/CD
How to Survive a DEA Inspection Series: "Understanding a DEA Computation Chart for Manufacturers or FIND=FINE"

How to Survive a DEA Inspection Series: "Understanding a DEA Computation Chart for Manufacturers or FIND=FINE"

  • Speaker: Carlos M Aquino
  • Product ID: 705163
  • Duration: 60 Min
The presentation is tailored for those corporate leaders and employees of DEA registered manufacturers responsible for handling Schedules I through V controlled substances and List I regulated chemical products. This training will cover several recommendations to improve your methods of record-keeping required of DEA registrants.
CD/Recorded
$0
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Recorded/CD
Maintaining Continuous HIPAA Compliance through Effective Monitoring and Auditing Practices

Maintaining Continuous HIPAA Compliance through Effective Monitoring and Auditing Practices

  • Speaker: John Steiner
  • Product ID: 703453
  • Duration: 60 Min
This webinar will explain how to design and administer HIPAA monitoring and auditing programs to meet HIPAA requirements. This session will cover some of the most common exceptions under the Privacy Rule and include practical tips for demonstrating good faith compliance efforts. In addition, there will be discussion of next-generation technologies that can help covered entities and business associates detect and report inappropriate accesses and disclosures of electronic protected health information.
CD/Recorded
$249
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Recorded/CD
MDR Program conforming to New FDA Guidance

MDR Program conforming to New FDA Guidance

  • Speaker: Edwin Waldbusser
  • Product ID: 705149
  • Duration: 60 Min
FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion.
CD/Recorded
$249
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Recorded/CD
Affordable Care Act (ACA); Discrimination; Interpreter and More: Complying with Section 1557: OCR and CMS Hospital CoPs

Affordable Care Act (ACA); Discrimination; Interpreter and More: Complying with Section 1557: OCR and CMS Hospital CoPs

  • Speaker: Sue Dill Calloway
  • Product ID: 705151
  • Duration: 120 Min
Section 1557 of the Affordable Care Act (ACA) forbids discrimination based on sex, race, color, national origin, age and disability. It builds on longstanding and familiar federal civil rights laws but is the first law to prohibit discrimination on the basis of sex (which includes gender, gender identity and sex stereotyping) in covered health programs and activities. Sex discrimination also includes discriminatory treatment on the basis of pregnancy, false pregnancy, termination of pregnancy, recovering from pregnancy, childbirth and related medical conditions, sex stereotyping, and gender identity.
CD/Recorded
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Recorded/CD
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

  • Speaker: Joy McElroy
  • Product ID: 704306
  • Duration: 90 Min
This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.
CD/Recorded
$299
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Recorded/CD
OSHA 101 - Nuts and Bolts of a Safer Workplace

OSHA 101 - Nuts and Bolts of a Safer Workplace

  • Speaker: Michael Aust
  • Product ID: 705099
  • Duration: 60 Min
This training program will illustrate five effective personal actions to enhance a safer workplace and describe the four different phases of the safety maturity curve. It will explain the four most common deflections of a safe workplace and how to minimize their impact.
CD/Recorded
$0
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