ComplianceOnline

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Good Documentation Guideline (Chapter <1029> USP)
14
/ Jul
Tuesday-2020

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
* Per Attendee
$229
Japan: Regulatory Compliance Requirements for Life Science Products
21
/ Jul
Tuesday-2020

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
* Per Attendee
$249
How to Go Global: 5 Proven Foreign Market Entry Techniques
21
/ Jul
Tuesday-2020

How to Go Global: 5 Proven Foreign Market Entry Techniques

  • Speaker: Douglas Cohen
  • Product ID: 704702
  • Duration: 60 Min
This webinar training will discuss the practical approach on how and why to grow business internationally. The instructor will discuss the benefits and risks of exporting, licencing, joint ventures and acquisitions. Participants will learn the key successful market entry techniques and will be able to deduce what suits best for their organisation.
* Per Attendee
$179
Import and Export - Improving Your International Trade Compliance Score
22
/ Jul
Wednesday-2020

Import and Export - Improving Your International Trade Compliance Score

  • Speaker: Deep SenGupta
  • Product ID: 703961
  • Duration: 60 Min
This international trade compliance training program will evaluate strategies such as drawback, foreign trade zones or free trade agreements. It will also offer guidance and best practice strategies for several import/export practices such as methodology for measuring trade compliance score, and determining export control classification number.
* Per Attendee
$299
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
22
/ Jul
Wednesday-2020

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 Min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$229
Successful 510(k) Submissions
22
/ Jul
Wednesday-2020

Successful 510(k) Submissions

  • Speaker: John E Lincoln
  • Product ID: 700815
  • Duration: 60 Min
In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software / firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.
* Per Attendee
$329
Interdisciplinary Care Rounds: A Key Strategy for Improving Case Management Outcomes
23
/ Jul
Thursday-2020

Interdisciplinary Care Rounds: A Key Strategy for Improving Case Management Outcomes

  • Speaker: Toni Cesta
  • Product ID: 705237
  • Duration: 60 Min
During this program, our experts will outline the roles of each team member in the rounding process as well as alternate communication strategies such as care conference, huddles, and internal transfers. Also included will be strategies for planning rounds and how to script team members to optimize time spent discussing each patient.
* Per Attendee
$199
How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual
28
/ Jul
Tuesday-2020

How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual

  • Speaker: Danielle DeLucy
  • Product ID: 704993
  • Duration: 60 Min
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
* Per Attendee
$229
Patient Access of Medical Records under HIPAA - New HHS Guidance, New Focus for HIPAA Audits
5
/ Aug
Wednesday-2020

Patient Access of Medical Records under HIPAA - New HHS Guidance, New Focus for HIPAA Audits

  • Speaker: Jim Sheldon-Dean
  • Product ID: 705220
  • Duration: 90 Min
This training program will provide a comprehensive look at the changes in the new access rights under HIPAA and CLIA regulations and prepare attendees for the process of incorporating the changes into how they do business in their facilities. It will also explain how the HIPAA audit and enforcement activities are now being increased and what needs to be done to survive a HIPAA audit.
* Per Attendee
$199
Steam Sterilization Microbiology and Autoclave Performance Qualification
6
/ Aug
Thursday-2020

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Danielle DeLucy
  • Product ID: 705027
  • Duration: 60 Min
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
* Per Attendee
$229
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
11
/ Aug
Tuesday-2020

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

  • Speaker: Kelly Eisenhardt
  • Product ID: 703871
  • Duration: 60 Min
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.
* Per Attendee
$199
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
11
/ Aug
Tuesday-2020

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
SaaS/Cloud Risk-Based Validation With Time-Saving Templates
12
/ Aug
Wednesday-2020

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

  • 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
$249
Best Practices for Setting Up a Global International Trade Compliance Program
12
/ Aug
Wednesday-2020

Best Practices for Setting Up a Global International Trade Compliance Program

  • Speaker: Deep SenGupta
  • Product ID: 703708
  • Duration: 60 Min
Attend this webinar to learn how to evaluate the trade compliance risk for your worldwide subsidiaries and how to ensure that your worldwide subsidiaries are adequately managing their trade compliance risk.
* Per Attendee
$299
Time Extension Requests - A Checklist
17
/ Aug
Monday-2020

Time Extension Requests - A Checklist

  • Speaker: Jim Zack
  • Product ID: 704345
  • Duration: 90 Min
This training program may well change the way in which you prepare or analyze the very next time extension request you have to deal with. It will discuss rules concerning time extension requests, arguments about waiver and apportionment of liquidated damages, concurrent delay issues and who has to prove concurrent delay, and more.
* Per Attendee
$199
Recorded/CD
Prevention of Infection in Healthcare Workers

Prevention of Infection in Healthcare Workers

  • Speaker: David Woodard
  • Product ID: 703636
  • Duration: 60 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.
CD/Recorded
$249
Recorded/CD
Implementing a Bullet Proof Quality System for FDA Audit Success

Implementing a Bullet Proof Quality System for FDA Audit Success

  • Speaker: Meena Chettiar
  • Product ID: 705400
  • Duration: 60 Min
This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.
CD/Recorded
$0
Recorded/CD
Workplace Investigations - Witnesses Interviews

Workplace Investigations - Witnesses Interviews

  • Speaker: Teri Morning
  • Product ID: 703048
  • Duration: 60 Min
This training will provide you the best practices on how to effectively interview witnesses while conducting workplace investigations. You will also learn how to avoid retaliatory behavior towards individuals involved in investigations or making complaints.
CD/Recorded
$229
Recorded/CD
Implementation and Management of GMP Data Integrity

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. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
CD/Recorded
$299
Recorded/CD
FDA's Ambitious Regulation of Social Media

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.
CD/Recorded
$279
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