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Home › Online Training ›  Regulatory Affairs

Regulatory Affairs Training - Live Webinars, Recordings & CDs

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Travel and Expense Policy Development and Automation
14
/ Jun
Friday-2019

Travel and Expense Policy Development and Automation

  • Speaker: Brian G Rosenberg
  • Product ID: 704880
  • Duration: 60 Min
In this webinar training, you will learn how to create, maintain, and enforce a T&E policy for your organization. The Instructors will discuss the key components and best practices for policies.
* Per Attendee
$179
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CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
19
/ Jun
Wednesday-2019

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Speaker: Sunil Gupta
  • Product ID: 704302
  • Duration: 90 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
* Per Attendee
$249
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Overtime: California Style for 2019
20
/ Jun
Thursday-2019

Overtime: California Style for 2019

  • Speaker: Vicki M. Lambert
  • Product ID: 704201
  • Duration: 90 Min
This training program will discuss the wage and hour requirements for calculating and paying overtime in the state of california. The course will elaborate the requirements for calculating overtime and double time in California to ensure compliance with the state’s wage and hour laws.
* Per Attendee
$179
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FDA's Ambitious Regulation of Social Media
24
/ Jun
Monday-2019

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
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Annual Current Good Manufacturing Practices (cGMP) Training
26
/ Jun
Wednesday-2019

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
* Per Attendee
$199
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Nursing: CMS CoP Standards for Hospitals and Proposed Changes: 2019 Update
26
/ Jun
Wednesday-2019

Nursing: CMS CoP Standards for Hospitals and Proposed Changes: 2019 Update

  • Speaker: Sue Dill Calloway
  • Product ID: 705239
  • Duration: 120 Min
This training program will cover requirements in the CMS hospital CoP manual on nursing section. It will discuss proposed changes in the Hospital Improvement Act including plans of care, staffing, policy changes, documentation, supervision, nursing leadership, verbal orders, antibiotic stewardship program and much more.
* Per Attendee
$199
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Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program
27
/ Jun
Thursday-2019

Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

  • Speaker: Todd Graham
  • Product ID: 703066
  • Duration: 60 Min
This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.
* Per Attendee
$229
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NAFTA Rules of Origin and Documentation (Comparisons and Updates on Pending USMCA)
27
/ Jun
Thursday-2019

NAFTA Rules of Origin and Documentation (Comparisons and Updates on Pending USMCA)

  • Speaker: Jan Seal
  • Product ID: 705498
  • Duration: 90 Min
This webinar will help attendees understand how to meet the rules that are required to qualify their imports/exports between the three NAFTA countries (United States, Canada, and Mexico). In addition, this webinar will present some of the differences between the NAFTA and the USMCA and issues that may still be pending before ratification. Some of these changes may impact your company and require advance preparation to meet compliance requirements.
* Per Attendee
$149
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How to Prepare a Customs Compliance Manual
27
/ Jun
Thursday-2019

How to Prepare a Customs Compliance Manual

  • Speaker: Donna L Shira
  • Product ID: 703319
  • Duration: 60 Min
This webinar will explain how to prepare a Customs manual that complies with CBP laws and regulations. Attendees will learn best practices for successfully passing an audit or becoming an Importer Self Assessment Program (ISA) member.
* Per Attendee
$129
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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
28
/ Jun
Friday-2019

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.
* Per Attendee
$229
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How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
28
/ Jun
Friday-2019

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.
* Per Attendee
$249
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Legal and Contractual Perspectives of Managing the Remote/Virtual Employee
28
/ Jun
Friday-2019

Legal and Contractual Perspectives of Managing the Remote/Virtual Employee

  • Speaker: Dr. Susan Strauss
  • Product ID: 704413
  • Duration: 90 Min

This webinar training discusses the legal and contractual perspectives of managing the remote/virtual employee. It will highlight the opportunities and challenges that the virtual workplace offers. The current competitive business environment and the changing nature of work and the workforce requires effective leadership that spans the boundaries of time and space to help employees to work together – apart. Participants will understand the dynamic interaction between technological systems and human systems that the virtual leader has to address and how to implement prevention strategies to minimize liability by designing and developing virtual policies.
* Per Attendee
$179
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Storm Water Pollution Prevention Plans (SWPPP)
28
/ Jun
Friday-2019

Storm Water Pollution Prevention Plans (SWPPP)

  • Speaker: Joe Keenan
  • Product ID: 705510
  • Duration: 90 Min
This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.
* Per Attendee
$149
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Implementation and Management of GMP Data Integrity
3
/ Jul
Wednesday-2019

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. Also attendees will examples of data integrity pitfalls, • part 11 compliance data integrity issues, FDA citations related to data integrity and how to improve data integrity in a laboratory environment.
* Per Attendee
$249
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HIPAA and Business Associates - New Guidance on Responsibilities and Obligations
8
/ Jul
Monday-2019

HIPAA and Business Associates - New Guidance on Responsibilities and Obligations

  • Speaker: Jim Sheldon-Dean
  • Product ID: 702610
  • Duration: 90 Min
This webinar will discuss the significant changes to the HIPAA rules for business associates, the new challenges for HIPAA covered entities and business associates, and new risks for non-compliance and penalties.
* Per Attendee
$199
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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
How to Conduct an Internal Harassment and Bullying Investigation to Determine Facts and Minimize Liability

How to Conduct an Internal Harassment and Bullying Investigation to Determine Facts and Minimize Liability

  • Speaker: Dr. Susan Strauss
  • Product ID: 704415
  • Duration: 120 Min
This webinar undertakes to explain the process of internal harassment and bullying investigation. Participants will learn how to handle harassment complaints and conduct the investigation to determine facts and minimize liability by analysing evidences, drawing conclusions, writing the formal report outlining the investigation and taking corrective actions where necessary.
CD/Recorded
$229
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Recorded/CD
Zero-Injury Workplace Culture vs. Safety Culture

Zero-Injury Workplace Culture vs. Safety Culture

  • Speaker: Joe Keenan
  • 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
$199
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Recorded/CD
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

  • Speaker: Robert J Russell
  • Product ID: 701369
  • Duration: 90 Min
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
CD/Recorded
$249
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Recorded/CD
Wage and Hour Law - California Style for 2019

Wage and Hour Law - California Style for 2019

  • Speaker: Vicki M. Lambert
  • Product ID: 703771
  • Duration: 90 Min
This 90 minute California wage and hour compliance training will help you understand the complexities surrounding California wage and hour laws and how it affects the function of any payroll department or company that has employees in California.
CD/Recorded
$229
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