eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

By: Peggy J. Berry, MBA, RAC ,President & CEO at Synergy Consulting.

Assure compliance with CDISC requirements?

  • 24-October-2018| 01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes

HIPAA and Staff Terminations — Managing Access to Prevent Breaches

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

Today, staff in medical offices have access to a number of systems that may be used for the access and management of Protected Health Information.

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

Live Webinar Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

By: José Mora ,Principal Consultant.

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process

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

A Comparison of ICH Q-10 Quality System and the FDA's Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

By: Howard Cooper, CBA, CQM ,Senior Regulatory Consultant.

FDA guidance documents on Pharmaceutical cGMPs

  • 24-October-2018| 01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes

Webinar How to properly document employee interactions

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

Meets the legal requirements of Federal statutes

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

The Use of EHR Data in Clinical Investigations (Research) – FDA’s Latest Guidance

By: Richard Chamberlain ,Owner at Extended Clinical Services, LLC.

EHR system in a submission to FDA

  • 25-October-2018| 01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes

How to Manage Your Vendors in Clinical Research

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Current FDA regulations and ICH guidelines

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

Introduction to Spreadsheets: Part 1

By: David H. Ringstrom, CPA ,CPA is president and founder of Accounting Advisors, Inc..

Structural basics of Excel worksheets and workbooks

  • 29-October-2018| 02:30 PM ET | 11:30 AM PT | 01:30 PM CT Duration 60 Minutes

FDA’s New Import Program for 2018: Be Prepared and Be Compliant

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

FDA and U.S. Customs and Border Protection

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

What International Labor Regulations Put Your Company At Risk For Fines, Penalties and Lawsuits?

By: Margie Faulk PHR, SHRM-CP ,Compliance Officer.

Services to international borders

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

Preparing for an FDA Medical Device Sponsor Inspection

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

New product-marketing approvals

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

Fundamentals in Utilization Management

By: Toni G. Cesta, Ph.D., RN, FAAN ,Consultant and Owner at Case Management Concepts, LLC.

Strategies for stream-lining the process

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

Accounts Payable Fraud - Detecting and Preventing AP Fraud

By: Craig Taggart ,Managing Director, BCC Capital Partners.

Criminals are coming up with new high-tech ways of hijacking

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

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

Preventing fraud should be a standard part of any compliance plan

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

Excel Insights: Automating Financial Statements

By: David H. Ringstrom, CPA ,CPA is president and founder of Accounting Advisors, Inc..

Exporting reports for spreadsheet analysis

  • 07-November-2018| 11:30 AM ET | 08:30 AM PT | 10:30 AM CT Duration 90 Minutes

Complaint Handling

By: Peggy J. Berry, MBA, RAC ,President & CEO at Synergy Consulting.

Effective internal systems for receiving

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

Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components

By: Howard Cooper, CBA, CQM ,Senior Regulatory Consultant.

Provides a higher level of quality

  • 07-November-2018| 01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes

Terminate for the Right Reasons-and Avoid Legal Headaches

By: Susan Fahey Desmond ,Attorney/Principal with Jackson Lewis PC.

How to handle tricky termination decisions

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

The ROI of Employee Engagement

By: B. Lynn Ware, Ph.D., CEO ,CEO of Integral Talent Systems, Inc..

Employees who are well supported and committed to their organization

  • 14-November-2018| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 60 Minutes

Establishing the Mentor-Mentee Relationship for your Organization

By: B. Lynn Ware, Ph.D., CEO ,CEO of Integral Talent Systems, Inc..

Implementing a mentorship program

  • 15-November-2018| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 60 Minutes

Multi-state Regulation Coordination! Learn How Employers Can Ensure Compliance with Current, New, and Proposed State Specific Laws!

By: Margie Faulk PHR, SHRM-CP ,Compliance Officer.

What works in one state will not work in another

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

FDA's Expectations from Supplier Management for GMP: Quality Agreements and More

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

FDA’s requirements without creating undue burdens for the organization

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

FDA's Recent Regulation on the Use of Social Media

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

Medical devices subject to FDA regulation

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

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

By: Jan Seal ,International Trade Consultant.

Learn how to take "reasonable care"

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

2018 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

How to write, organize, and maintain SOPs and train personnel

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

Five things Medical Device Industry should expect in 2019

By: Milind Nadgouda ,Co- founder and Director at RiverArk Limited.

What to expect in 2019

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

Complying with Pregnancy Discrimination Act - What to Expect When Your Employee Is Expecting

By: Susan Fahey Desmond ,Attorney/Principal with Jackson Lewis PC.

Without falling afoul of the law

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

FDA Inspection Readiness

By: Pam Dellea-Giltner ,CEO and principal auditor of PDG Clinical Consulting LLC.

What it means to be “Inspection Ready”

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

FDA Regulation of Digital Health – Current Status and Recent Developments

By: David R. Dills ,Director of Regulatory Services at CROMSOURCE.

FDA focusing on Digital Health?

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

Live Webinar Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Electronic Records & Electronic Signatures

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

What’s New in Onboarding?

By: B. Lynn Ware, Ph.D., CEO ,CEO of Integral Talent Systems, Inc..

Developing and implementing a well though out process

  • 06-December-2018| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 60 Minutes

The IRS is Coming: How to Prepare for the New IRS Partnership Audit Rules

By: Craig Taggart ,Managing Director, BCC Capital Partners.

Try their hand at solving the issue, while balancing compliance

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

Live Webinar European Data Protection Regulation – 2018 Implementation

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

European Data Protection Regulation

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

FDA Compliance and Mobile Applications

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

Understanding of computer system validation planning, execution and management concepts

  • 10-December-2018| 01:00 PM EDT | 10:00 AM PT | 12:00 PM CT Duration 90 Minute

Building a World-Class Advertising and Promotion Review Program

By: Peggy J. Berry, MBA, RAC ,President & CEO at Synergy Consulting.

Compliance within the US, "gray areas"

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

Payroll Fraud: Detection and Prevention Best Practices

By: Peter Goldmann ,Founder and President of FraudAware LLC.

Find patterns, red flags and stop scams

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

3-hrs Virtual Training 2018 Latest FDA thinking on deciding when to Submit a 510(k) for a Change to an Existing Device – FDA’s Final Guidance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

By FDA Expert 30+ years exp.

  • 14-December-2018| 12:00 PM EDT | 9:00 AM PDT | 11:00 PM CDT Duration 180 Minutes

Volatile Termination: Be Prepared to Handle Terminations with Employees Who Are Aggressive, Own Weapons, Have Mental Illness and Other Issues You Are Not Aware They Have!

By: Margie Faulk PHR, SHRM-CP ,Compliance Officer.

Employees without fear of retribution from the regulatory agencies

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

Top 10 Employment Cases of 2018 - Be Better Prepared in 2019

By: Susan Fahey Desmond ,Attorney/Principal with Jackson Lewis PC.

The most interesting court decisions in 2018

  • 22-January-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

How Is Social Media Impacting How Employers Discipline Employees?

By: Margie Faulk PHR, SHRM-CP ,Compliance Officer.

Must learn how to navigate the social media environment

  • 24-January-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
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