ComplianceOnline

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Surviving an FDA Sponsor Inspection - Training for Success
20
/ Feb
Wednesday-2019

Surviving an FDA Sponsor Inspection - Training for Success

  • Speaker: Stephen Schwartz
  • Product ID: 704516
  • Duration: 105 Min
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
* Per Attendee
$249
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
20
/ Feb
Wednesday-2019

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
* Per Attendee
$249
Current Concepts and Challenges in Cloud Compliance
21
/ Feb
Thursday-2019

Current Concepts and Challenges in Cloud Compliance

  • Speaker: Angela Bazigos
  • Product ID: 703739
  • Duration: 90 Min
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
* Per Attendee
$229
Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory
21
/ Feb
Thursday-2019

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

  • Speaker: Gregory Martin
  • Product ID: 702534
  • Duration: 120 Min
This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
* Per Attendee
$299
Introduction to Root Cause Investigation for CAPA
21
/ Feb
Thursday-2019

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
* Per Attendee
$229
A+ Compliance with Mental Disorders in the Workplace: Surviving the FMLA, ADA and Workers Compensation Tsunami
21
/ Feb
Thursday-2019

A+ Compliance with Mental Disorders in the Workplace: Surviving the FMLA, ADA and Workers Compensation Tsunami

  • Speaker: Elga Lejarza
  • Product ID: 703914
  • Duration: 90 Min
This training program will discuss the knowledge and skills needed to develop a comfortable level managing the Family and Medical Leave Act (FMLA), the Americans with Disabilities Act (ADA) and Workers Compensation, separately or when they interconnect. At the end of the webinar, attendees will understand the interplay of these laws to assure legal compliance as well as to provide employees with the benefits and protections each law provides.
* Per Attendee
$199
Bundled Payment Review: How Case Management Can Play a Strategic Role
22
/ Feb
Friday-2019

Bundled Payment Review: How Case Management Can Play a Strategic Role

  • Speaker: Toni Cesta
  • Product ID: 705119
  • Duration: 60 Min
This webinar will teach you how bundled payments actually work as they move from demonstration to reality. It will discuss how case management must become a fully integrated across the continuum model.
* Per Attendee
$199
Travel and Expense Policy Development and Automation
22
/ Feb
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
Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
26
/ Feb
Tuesday-2019

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
$229
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
26
/ Feb
Tuesday-2019

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 90 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
CDISC Mapping 1: Specifications and FDA Requirements
27
/ Feb
Wednesday-2019

CDISC Mapping 1: Specifications and FDA Requirements

  • Speaker: Sunil Gupta
  • Product ID: 704152
  • Duration: 90 Min
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
* Per Attendee
$229
FDA Compliance and Clinical Trial Computer System Validation
27
/ Feb
Wednesday-2019

FDA Compliance and Clinical Trial Computer System Validation

  • Speaker: Carolyn Troiano
  • Product ID: 705358
  • Duration: 60 Min
This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.
* Per Attendee
$229
21 CFR Part 11 and Annex 11 Compliance; Specifics for Data Integrity with SaaS/Cloud
28
/ Feb
Thursday-2019

21 CFR Part 11 and Annex 11 Compliance; Specifics for Data Integrity with SaaS/Cloud

  • 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
$229
Country of Origin Marking for Imports/Exports
28
/ Feb
Thursday-2019

Country of Origin Marking for Imports/Exports

  • Speaker: Jan Seal
  • Product ID: 704785
  • Duration: 90 Min
This training program will focus on regulations that apply to most goods imported into the United States and illustrate them with examples. In addition, attendees will learn more about country of origin marking for exports from the United States to other countries.
* Per Attendee
$149
Prevention of Infection in Healthcare Workers
28
/ Feb
Thursday-2019

Prevention of Infection in Healthcare Workers

  • Speaker: Sue Barnes
  • Product ID: 703636
  • Duration: 90 Min
For healthcare facilities and long-term care facilities looking to promote employee safety in the workplace, this webinar will provide essential information on structuring your employee health program as per Center of Disease Control (CDC), Occupational Health and Safety Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and the National Institute for Occupational Safety and Health (NIOSH) recommendations.
* Per Attendee
$199
Recorded/CD
Harmonized Tariff Schedule Classification

Harmonized Tariff Schedule Classification

  • Speaker: Jan Seal
  • Product ID: 705224
  • Duration: 90 Min

Understand the rules that are required to classify products in the Harmonized Tariff Schedule. Learn to minimize errors in classification and better prepare companies for import/export audits from the government. The webinar will also assist companies who are eligible for free trade agreements, ex. NAFTA, and other agreements, in properly completing Certificates of Origin.

The Harmonized Tariff Schedule (HTS) is used by over 200 countries, territories, or customs unions around the world to assign a number to each product to establish the appropriate duty that should be paid when goods are imported into a country. The HTS is also used to determine whether goods are subject to quotas or free trade agreements. Proper classification is also vital for establishing eligibility under many free trade agreements, i.e. completion of the NAFTA Certificate of Origin for trade between U.S., Canada, and Mexico as well as trade agreements between the U.S. and Chile, Singapore, Australia, and the Central America-Dominican Republic.

CD/Recorded
$179
Recorded/CD
Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

  • Speaker: Saeed Qureshi
  • Product ID: 705271
  • Duration: 120 Min
This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.
CD/Recorded
$0
Recorded/CD
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

  • Speaker: Roger Cowan
  • Product ID: 703831
  • Duration: 60 Min
Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.
CD/Recorded
$299
Recorded/CD
Food Safety and Security - Ensuring Food Safety from Farm to Fork

Food Safety and Security - Ensuring Food Safety from Farm to Fork

  • Speaker: John Ryan
  • Product ID: 701812
  • Duration: 60 Min
This food safety webinar will discuss the currently accepted food safety practices and how the newly evolving system for food safety is about to be put in place.
CD/Recorded
$229
Recorded/CD
Sample Quality Control for Molecular Diagnostics

Sample Quality Control for Molecular Diagnostics

  • Speaker: Todd Graham
  • Product ID: 705222
  • Duration: 60 Min
In this webinar attendees will learn the key issues and sample requirements (collection methods, sample inhibition and sample volume) for molecular diagnostics and the tools (PCR, DNA fluorescent assays & NGS assays) you need to deal with your laboratory challenges in clinical laboratory.
CD/Recorded
$299
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