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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
Record Keeping for a food Recall: Keeping Records to Minimize the Affect of a Recall

Record Keeping for a food Recall: Keeping Records to Minimize the Affect of a Recall

  • Speaker: Craig Nelson
  • Product ID: 701119
  • Duration: 60 Min
This Food safety training will provide valuable guidance to management, supervision, and quality staff that are involved with record keeping for product and ingredient traceability and recall.
CD/Recorded
$199
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Recorded/CD
Understanding the Harmonized Microbial Limits Tests - stressing the new compendial chapters, validation, verification and new expectations in USP <1111>

Understanding the Harmonized Microbial Limits Tests - stressing the new compendial chapters, validation, verification and new expectations in USP <1111>

  • Speaker: Scott Sutton
  • Product ID: 701238
  • Duration: 85 Min
This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.
CD/Recorded
$299
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Recorded/CD
Legal & Ethical Challenges for Employers: An Increase In Burnout, Stress, & Mental Illness

Legal & Ethical Challenges for Employers: An Increase In Burnout, Stress, & Mental Illness

  • Speaker: Dr. Susan Strauss
  • Product ID: 706946
  • Duration: 90 Min
Employers are seeing more mental health issues in their workforce than ever before. Long COVID has enhanced mental health concerns even more. Each year 1 in 5 adults is stricken with a mental illness (National Institute of Mental health), making mental illness an everyday reality for many of your employees. Yet only 1 in 3 people seek help with their illness. The ADA, HIPPA, FMLA and most states’ human/civil rights department dictate how employers deal with employees with mental health problems and could charge employers with civil rights liability. Privacy laws create challenges for employers to determine how serious a situation is and whether an employee poses a danger (though those with a mental illness pose no more risk of violence than those without a mental illness). Two thirds of employees would take a pay cut for a job that supports mental health – do you? As a manager, what can you do to better recognize and take care of your employees’ mental health? Seventy percent of employees could do more to support their employees’ mental health according to the Society of Human Rights Management (SHRM, February 15, 2023).
CD/Recorded
$0
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Recorded/CD
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

  • Speaker: Michael Ferrante
  • Product ID: 703538
  • Duration: 90 min
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
CD/Recorded
$249
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Recorded/CD
Record Keeping for the Bioterrorism Act: Meeting and Exceeding the Requirements in a Simple Manner

Record Keeping for the Bioterrorism Act: Meeting and Exceeding the Requirements in a Simple Manner

  • Speaker: Craig Nelson
  • Product ID: 701318
  • Duration: 60 Min
This Bioterrorism act training will provide the attendee a clear understanding of what is expected, how an investigation will proceed, and how to keep records that will minimize the impact of an incident.
CD/Recorded
$299
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Recorded/CD
Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry Part II

Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry Part II

  • Speaker: Robert J Russell
  • Product ID: 701267
  • Duration: 90 Min
This Regulatory compliance training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
CD/Recorded
$0
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Recorded/CD
Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry PART I

Latin America - Understanding Regulatory Compliance Requirements Across Life Science Industry PART I

  • Speaker: Robert J Russell
  • Product ID: 701260
  • Duration: 60 Min
The Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
CD/Recorded
$0
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Recorded/CD
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

  • Speaker: Robert J Russell
  • Product ID: 701266
  • Duration: 90 Min
This Japan Regulatory Filing training for life sciences is designed to provide an overview of the regulatory environment in Japan.
CD/Recorded
$0
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Recorded/CD
Control Activities Component of COSO at the Entity Level

Control Activities Component of COSO at the Entity Level

  • Speaker: John C Blackshire
  • Product ID: 700974
  • Duration: 90 Min
This COSO training will provide an in depth look at the Control Activities Component of COSO at the Entity Level. The goals of these principles within this Component are to allow for the Key Controls at various layers and levels within ICFR to reduce risks of achievement of financial reporting objectives.
CD/Recorded
$299
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Recorded/CD
Japanese PAL - Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder)

Japanese PAL - Dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder)

  • Speaker: Phil Smart
  • Product ID: 701277
  • Duration: 90 Min
This JPAL training will describe requirements, common mistakes & best practices while dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder).
CD/Recorded
$299
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Recorded/CD
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I

  • Speaker: Robert J Russell
  • Product ID: 701258
  • Duration: 90 Min
This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.
CD/Recorded
$299
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Recorded/CD
Japanese PAL - Navigating the Japanese Pharmaceutical Affairs Law

Japanese PAL - Navigating the Japanese Pharmaceutical Affairs Law

  • Speaker: Phil Smart
  • Product ID: 701276
  • Duration: 90 Min
This JPAL training will emphasize on Japanese Pharmaceutical Affairs law with respect to - Classification, device approvals, clinical data, MAH (Marketing Authorization Holder),foreign manufacturer accreditation,QMS,post-market complaints & vigilance
CD/Recorded
$299
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Recorded/CD
HACCP in a Real World Environment

HACCP in a Real World Environment

  • Speaker: John Miller
  • Product ID: 701173
  • Duration: 60 Min
This HACCP training will explain the FSIS regulations and policies program requirements.
CD/Recorded
$50
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Recorded/CD
Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500

Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500

  • Speaker: Jeff Odum
  • Product ID: 701207
  • Duration: 60 Min
This Biopharmaceutical training will introduce and link the concepts of GEP and QbD and also identify synergies with the new ASTM E2500 standard Biopharmaceutical Active Pharmaceutical Ingredients (APIs) must be produced according to Good Manufacturing Practices outlined in FDA and ICH guidelines in order to be marketed to the public. This webinar will review the areas that an inspector may examine when conducting an audit of a biopharmaceutical API supplier to ensure it complies with regulatory requirements.
CD/Recorded
$129
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Recorded/CD
Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA's new requirements

Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA's new requirements

  • Speaker: R. Wayne Frost
  • Product ID: 701155
  • Duration: 60 Min
This FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.
CD/Recorded
$299
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Recorded/CD
Rules of Practice (FSIS) 9CFR part 500

Rules of Practice (FSIS) 9CFR part 500

  • Speaker: John Miller
  • Product ID: 701172
  • Duration:
This Food Safety and Inspection Service (FSIS) training will guide you through the different levels of enforcement that FSIS utilizes.
CD/Recorded
$199
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Recorded/CD
21 CFR Part 11 compliance under the Obama administration

21 CFR Part 11 compliance under the Obama administration

  • Speaker: Alfonso Fuller
  • Product ID: 701215
  • Duration: 60 Min
This 21 CFR Part 11 training will deliver concrete guidance which will provide a roadmap for compliance that will have immediate benefits, withstand FDA’s changes to Part 11, and discuss the new Obama administration approach to enforcement.
CD/Recorded
$299
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Recorded/CD
Critical Control Points (CCP’s). Where are they? Why? When?

Critical Control Points (CCP’s). Where are they? Why? When?

  • Speaker: Irwin Pronk
  • Product ID: 701180
  • Duration: 60 Min
This Food safety compliance training will explain the CCP Decision Tree and help you understand the principles behind each question. We will review various food processing steps in a variety of situations to determine whether they are CCP’s. What is the thought process in determining a CCP? Can it be done consistently? What criteria are used? Are some processing steps always CCP's e.g. heating? If not, why? One thing to remember is the importance of analyzing the hazards at each step very carefully. The more clearly the hazards are described (including equipment failures, personnel errors etc) the easier it will be to find the CCP.
CD/Recorded
$199
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Recorded/CD
Analytical Instrument and Equipment Qualification in GXP and EPA Laboratories: USP 1058 and Beyond

Analytical Instrument and Equipment Qualification in GXP and EPA Laboratories: USP 1058 and Beyond

  • Speaker: Richard Poser(PhD)
  • Product ID: 701120
  • Duration: 90 Min
This Laboratory compliance training will review the regulations that cover each environment and present simple and effective strategies for satisfying the requirements. The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP (Good Laboratory Practices) labs supporting animal toxicology studies and GCP (Good Clinical Practices) labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated.
CD/Recorded
$299
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Recorded/CD
Validation & Verification: Differences between USDA and Codex

Validation & Verification: Differences between USDA and Codex

  • Speaker: Irwin Pronk
  • Product ID: 701179
  • Duration: 90 Min
This Food safety compliance training will help you understand the significant differences between the two words and even multiple meanings of the term ’Verification’. Between USDA and Codex there are slight differences and on top of that the definitions have changed over the years. It is very easy to get confused. By going back to principles, referring to other standards (e.g. ISO9000) and simpler terminology students will clearly understand the intent of both Validation and Verification. Having clarified the intent and principles we will review examples of Verification in both Prerequisite Programs and CCP's.

Validation will be explained, especially as it relates to validation of CCP's though the concept pervades the entire HACCP process. Examples will include Cooking, Cooling, and Allergen Cleaning. We will also discuss the two aspects of Validation; the product risk (microbiological, chemical or physical) as well as the Capability of the process. Both must be understood to ensure the control of CCP's is robust. Methods to verify the entire HACCP System will be covered and how this is different from verifying Prerequisite Programs and CCP's.
CD/Recorded
$199
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