Webinar Medical Devices 101 - Overview of Key Regulatory Requirements - Do’s, Don’ts and Real-World Examples

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This course is intended to provide an overview of the regulatory requirements for medical devices or what is sometimes referred to as Devices 101.

  • 25-June-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar How to Conduct Workplace Investigations - Best Practices and Know How's

By: Michael D. Haberman ,Consultant, Advisor and Writer, Omega HR Solutions, Inc..

Today the EEOC receives thousands of complaints for harassment and discrimination that cost employers millions in penalties and fines.

  • 26-June-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar EO Sterilization Validation / Revalidation per ISO 11135

By: John E Lincoln ,Principal of J. E. Lincoln and Associates LLC.

A brief discussion of the lethal rate BI / bioburden approach, and a more detailed discussion of the more commonly used Overkill approach descriptions,

  • 26-June-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Import Compliance & Implementation of Procedures for U.S. Companies

By: Jan Seal ,International Trade Consultant.

Free documents: PDF Print only copy of PPT slides

  • 26-June-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Understanding and Implementing a Technology Transfer Process

By: Steven Laurenz ,Principal Consultant, Biophia Consulting Inc.

Identify New Product transfer process

  • 27-June-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar System Development Life Cycle Approach to Computer System Validation and FDA Compliance

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Good Documentation Practices for FDA-Regulated Computer System Validation

  • 27-June-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Tax Reform and the Payroll Professional

By: Dayna Reum ,CPP, FPC ,Director of Payroll Operations.

Tax Reform bill is changing

  • 27-June-2018| 12:00 PM ET | 9:00 AM PT | 11:00 AM CT | Duration 60 Minutes

Live Webinar Lead Productive Meetings: Stop Wasting Time; Start Getting Results and Even Have Some Fun

By: Marcia Zidle ,Executive and Leadership Coach.

Free documents/Article/ebooks/sops/checklist for Attendee

  • 28-June-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Understanding Aseptic Technique and Cleanroom Behavior

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

Aseptic technique, in sterile compounding, contributes in preventing microbiological contamination.

  • 28-June-2018| 11:00 AM ET | 08:00 AM PDT | 10:00 AM CDT Duration 60 Minute

Webinar Getting R&D on Board with Risk Analysis

By: Tom Kramer ,President & CEO, Speaker.

ISO 14971 & risk management

  • 29-June-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

By: Mike Colvin Ph.D. ,Medical Device Consultant.

Overview of ISO 10993-1

  • 29-June-2018| 12:00 PM ET | 9:00 AM PT | 11:00 AM CT Duration 90 Minutes

Live Webinar European Data Protection Regulation – 2018 Implementation

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

European Data Protection Regulation

  • 03-July-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Difference Between Mentor and Coach in Motivating Employees Presented by Valerie Pelan

By: Valerie Pelan, MBA, PCC ,Executive Leadership Coach - Career Coach - Leadership for 21st Century.

Learn the different skills to mentor, coach, and manage employees.

  • 10-July-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

International letters of credit

By: Jan Seal ,International Trade Consultant.

Documentary credit

  • 10-July-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Live Webinar Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

By: Danielle DeLucy ,Principal/Owner, ASA Training & Quality Consulting, LLC.

undertake the planned investigation, change control, risk assessment or validation

  • 11-July-2018| 11:00 AM ET | 08:00 AM PDT | 10:00 AM CDT Duration 90 Minute

2018 FDA Guidelines for 510(k) Submission

By: Dr. David Lim Ph.D., RAC, ASQ-CQA ,President and Principal of Regulatory Doctor.

Process leading to timely clearances

  • 11-July-2018| 01:30 PM EDT | 10:30 AM PDT | 12:30 PM CDT Duration 60 Minutes

How to Handle Workplace Distractions: Creating a Focused, Productive and Profitable Working Environment

By: Lyman Montgomery ,President and CEO.

Speaker : Lyman Montgomery has over twenty- five years of HR experience in Employee Relations dealing with workplace issues and performance management. He is also

  • 11-July-2018| 02:00 PM EDT | 11:00 AM PDT | 01:00 PM CDT Duration 60 Minutes

Live Webinar Violence at Work: From Disgruntled Employees and Domestic Violence to Active Shooter

By: Dr Susan Strauss ,Workplace and Education Harassment & Bullying Consultant.

To summarize the warning signs of a potential perpetrator

  • 12-July-2018| 11:00 AM EDT | 08:00 AM PDT |10:00 AM CDT Duration 60 Minute

How the FDA are Trained for Medical Device Inspections

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Listing Regulation (21 CFR 807)

  • 13-July-2018| 12:00 AM ET | 9:00 AM PT| 1 1:00 AM CT Duration 180 Minutes

Live Webinar Building effective project teams

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Building the project team

  • 16-July-2018| 03:00 PM EDT | 12:00 PM PDT | 02:00 PM CDT Duration 60 Minute

Live Webinar GAME OF ZONES: A PRACTICAL APPLICATION OF FDA GUIDANCE DOUMENT – “CONTROL OF LISTERIA MONOCYTOGENES IN READY–TO–EAT FOODS”

By: Tim Lombardo ,Lead Staff Scientist.

This webinar will provide attendees an example driven, step by step testing program template for demonstrating the effectiveness of your food safety programs.

  • 17-July-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Investigating and Preventing Sexual Harassment Claims in the Workplace

By: Janette Levey Frisch ,Employment/HR Attorney| Founder, Law Office of Janette Levey Frisch|The Employer's Legal Wellness Professiona.

How to be proactive in ensuring a harassment-free work environment.

  • 17-July-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Updating Your Employee Handbook to Comply With New Laws in 2018

By: Margie Pacheco Faulk ,Sr HR Consultant, HR Compliance Solutions.

Employee handbook that will reduce your companies risk

  • 20-July-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minute

3 Hours Webinar : How to Survive an FDA Food Facility Inspection ?

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data

  • 23-July-2018| 12:00 PM EDT | 9:00 AM PDT | 11:00 PM CDT Duration 210 Minutes

Webinar Texting, E-mail, and Mobile Devices: Using Modern Communications According to HIPAA by Jim Sheldon-Dean

By: Jim Sheldon-Dean ,Principal and Director of Compliance Services, Lewis Creek Systems, LLC.

Learn about how the HIPAA audit and enforcement activities are now being increased and what you need to do to survive a HIPAA audit.

  • 24-July-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar FDA Compliance and GAMP V Computer System Classification

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

21 CFR Part 11 (electronic records/ electronic signatures)

  • 24-July-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Harmonized Tariff Schedule Classification

By: Jan Seal ,International Trade Consultant.

Best Practices for HTS Written Procedures

  • 24-July-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Emotional Intelligence: The Key to Long-Term Leadership and Career Success

By: Marcia Zidle ,Executive and Leadership Coach.

How you can easily “raise” your EQ to stand out

  • 24-July-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Write effective SOPs & Work Instructions

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

The true purpose and function of regulatory documentation.

  • 25-July-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Unemployment Insurance: Managing the Costs and Liabilities

By: Ronald L. Adler ,President-CEO at Laurdan Associates, Inc..

Through effective UI cost management, organizations can control their UI tax liability and have positive impact on their financial results.

  • 27-July-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar The prevention of human error in pharmaceutical manufacturing

By: Charles H Paul ,President at C. H. Paul Consulting, Inc.

Human Error occurs in all settings

  • 03-August-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar FDA vs Health Canada

By: Rachelle D’Souza ,CEO and President, Regulatory Heights Inc.

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 mins Live Webinar

  • 06-August-2018| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 90 Minutes

International Commercial Terms of Sale (INCOTERMS®) Webinar

By: Jan Seal ,International Trade Consultant.

11 Incoterms

  • 07-August-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Live Webinar Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

By: Carolyn Troiano ,ERP Project Manager/FDA Compliance Consultant.

Disaster Recovery and Business Continuity

  • 08-August-2018| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Preparation for a U.S. Customs & Border Protection Audit

By: Jan Seal ,International Trade Consultant.

Learn how to take "reasonable care"

  • 21-August-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Analytical Methods Validation for FDA Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

To enhance Analytical Method Validation

  • 03-September-2018| 12:00 AM ET | 9:00 AM PT | 11:00 AM CT Duration 180 Minutes

Off Label Promotion for Drugs & Medical Devices

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

How FDA can reconcile

  • 02-October-2018| 12:00 AM ET | 9:00 AM PT | 11:00 AM CT Duration 180 Minutes

Data Integrity – FDA’s Latest Thinking

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Data be reliable and accurate.

  • 08-November-2018| 12:00 AM ET | 9:00 AM PT | 11:00 AM CT Duration 180 Minutes
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