Live Webinar Protecting Your Business with the 5 Critical Conflict Minerals and Anti-Trafficking Regulations

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

An in depth look into regulations enacted to manage sourcing of materials from war torn countries and the prevention of supply chain human trafficking and

  • 12-December-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Reporting HIPAA Breaches — When health information is compromised, who must be notified, how, and when

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

how to create the right breach notification policy for your organization and how to follow through when an incident occurs.

  • 12-December-2017| 12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 90 Minute

Live Webinar Post Marketing and Regulatory Complinace

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

The post-marketing obligations encompass more functional areas of the company

  • 06-December-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar : Master Verification and Validation Planning and Implementation

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

Verification and validation requirements have always been part of the US FDA’s GMPs

  • 06-December-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Process Validation - Statistical Process Control

By: JERRY DALFORS ,Principal, JD Technologies.

To gain a current comprehension of the new PV Guidelines

  • 05-December-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar The top five wage and hour mistakes employers make

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

Department of Labor and the increased aggressiveness being shown it is important for companies to understand the Fair Labor Standards Act in greater detail.

  • 05-December-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

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

By: Dr. Susan Strauss RN Ed.D. ,Workplace & School Harassment & Bullying Consultant, Trainer, Expert Witness, Investigator.

This training program helps in identifying the critical components of harassment/bullying investigation in order to determine correct facts and reducing liabilities.

  • 05-December-2017| 12:30 PM EDT | 9:30 AM PDT | 11:30 AM CDT Duration 120 Minutes

Live Webinar :Appraising Credibility, Reaching Conclusions and Writing an Investigative Report: A Critical Step to Minimize Liability

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

An investigation that is not documented basically did not occur.

  • 05-December-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Talent Management: How Smart Companies Engage and Retain Their Millennial Talent

By: Marcia Zidle ,Executive and Leadership Coach.

Learn cost-effective and proven ways to engage and retain your millennial talent that can be implemented b your managers immediately.

  • 04-December-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

3 hr Live Webinar Reduce Human Error on the Drug and Device Manufacturing Processes

By: Ginette M. Collazo ,Ph.D, President, Ginette M. Collazo, Inc..

Human Error as the Root Cause

  • 29-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Live Webinar Project Management for Computer Systems Regulated by FDA

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

This course will describe the best practices for managing such a project, including "who" should be responsible for tasks, "how" the documentation should be accomplished,

  • 29-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Validation Concepts for Medical Devices By Susanne Manz

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Validation is an important element of the Quality System Regulations and ISO13485.

  • 22-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar on Cybersecurity By Angela Bazigos

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

When hackers breach cybersecurity defenses, the risks to enterprises are enormous.

  • 17-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Design Control, Device Risk Management, and Usability Engineering, Under US CGMPs 21 CFR 820 and ISO 13485

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

The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. ISO 13485:2016

  • 15-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

How to Evaluate Payroll Provider Vendors and Minimize Implementation Nightmares!

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

There are consistent processes, implementation concerns, technology glitches and integration pitfalls that if you are not prepared, you can regret the decision to consider upgrading

  • 15-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

3 hrs Webinar : Are You Aware if Your Company needs to be compliant with New Privacy Laws? Did You Know that Your Company Might Need to Be Compliant with the General Data Protection Regulations (GDPR)

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

Learn the historical perspectives in privacy concerns

  • 15-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

3 Hrs Webinar on 505(b)(2) NDAs By Peggy J. Berry, (Ex FDA)

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

What is a 505(b)(2)

  • 14-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

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

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

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

  • 08-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar: Finding the Right Fit: Using Behavioral Interviewing to Uncover Integrity/Honesty Concerns

By: Wes Pruett ,Owner at HR Advisors, Leadership Coach, facilitator, HR consultant.

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

  • 08-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Calculating Overtime Correctly under the Fair Labor Standards Act

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

What the FLSA requires with regard to minimum wage and overtime.

  • 07-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar ICH Q11- API Manufacturing

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Q11 guidance and learn skills for practical implementation of those requirements.

  • 01-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach

By: JERRY DALFORS ,Principal, JD Technologies.

Different microorganisms in different environments during sterilization have different resistance to the destructive principles that causes the organism or spore to die (lethality) Some extreme

  • 01-November-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Thinking ahead five years in HR

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

How to apply practical HR futurism practices to your HR department in order to prepare you to help make an impact and to prepare for

  • 26-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

3 Hour Webinar: How the FDA is Trained on Medical Device Inspections

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms

  • 26-October-2017| 12:00 PM EDT | 9:00 AM PDT | 11:00 AM CDT Duration 180 Minutes

Live Webinar Beyond Handbooks, Benefits, and Photo IDs: The Role of HR and Management in New Employee Onboarding

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

Onboarding needs to include fun activities, using “buddies” to streamline the new hire’s experience, beginning from the point of the job offer. It is one

  • 25-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar : Software / Firmware Verification and Validation to Meet Regulatory Requirements

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

Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical,

  • 25-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Critical Factors when Developing an Employee Handbook That Protects Your Company!

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

Did you know that Employee Handbooks can be a risk or a benefit for Employers? For years an Employee Handbook has been one of the

  • 19-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

3-hour webinar: Training & Development in the Life Sciences

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

Webinar Includes : All the training handouts , certificate ,Q/A and 3 Hrs Live Webinar

  • 19-October-2017| 12:00 PM EDT | 9:00 AM PDT | 11:00 PM CDT Duration 180 Minutes

Live Webinar Achieving Sustainability Results with ISO 26000

By: Kelly Eisenhardt ,Co-Founder and Managing Director of BlueCircle Advisors.

Social responsibility is a high priority for corporate leaders focused on increasing brand awareness along with revenues. It has become a critical success factor for

  • 18-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar FDA Focus:Purchasing / Supplier Controls for Medical Devices

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls.

  • 18-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar How to Handle,Identify and Investigate FMLA Abuse

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

Learn How to Minimize the Misuse of FMLA Leave

  • 17-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar DHF, DMR, DHR, and Technical File / Design Dossier – And the New EU MDR

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

Requirements for the U.S. FDA's DHF per the CGMPs, 21 CFR 820.30 and the almost now identical ISO 13485:2016 Design and Development File -- including

  • 17-October-2017| 12:30 PM EDT | 09:30 AM PDT | 11:30 AM CDT Duration 90 Minutes

Live Webinar Texting and E-mail with Patients - Meeting Patient Requests within the HIPAA Rules

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

This HIPAA compliance training will explain how HIPAA requirements for privacy and security can be reconciled with patient requests for information to be provided by

  • 17-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Review of global strategic drug development opportunities

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Learn how to plan, control and manage a full global development

  • 12-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Pediatric Safety Plan (PSP) in the US

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Learn how to prepare a PSP

  • 12-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Quality Assurance During the Clinical Trial

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

This course will give you an introduction to where to do quality assurance and how to do it.

  • 12-October-2017| 12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 90 Minute

Live Webinar Preventing Medical Device Recalls

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

In a recent study, the FDA has reported a 95% increase in medical device recalls

  • 12-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Strategies for Avoiding Employment Discrimination Claims

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

This webinar will familiarize you with and sensitize you to the key pitfalls to be aware of and avoid and provide you with some practical

  • 10-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Development and Audit of Complaint Handling and MDR Processes

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Application of risk management to complaint handling program

  • 09-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Batch Production Record and Device History Record Review and Quality Assessment to ensure compliance with DMF and DMR specifications

By: JERRY DALFORS ,Principal, JD Technologies.

BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch

  • 05-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Implementing a Change Control Quality System Successfully

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

  • 05-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Drug Discovery & Development: the FDA Way

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

The Drug Discovery and Development (but also the biologics and medical device) process is a very complex process with every participant focusing on their particular

  • 05-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

3-hour Webinar:NAFTA 2.0: Current State of Renegotiations and How It Could Affect You

By: Douglas Cohen ,Senior Manager for Global Trade and Contracts, Worldwide Trade and Legal Associates.

  • 04-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Live Webinar :Device Warning Letters - Review

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Learn the FDA process for issuance of warning letters

  • 03-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live webinar Country of Origin Marking for Imports/Exports

By: Jan Seal ,International Trade Consultant.

Exporters and manufacturers that ship goods to the United States will benefit by understanding U.S. marking regulations to properly mark their products before shipping them

  • 03-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Biosafety and Blood borne Pathogen Safety in the Lab

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

This webinar will review the regulations and guidelines recommended by the Centers for Disease Control and Prevention

  • 03-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar HR Metrics: 2017 Key Issues for Human Resource Management

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

As organizations increasingly place value on business metrics, HR will need to identify and update the strategic and operational metrics that it measures and reports.

  • 02-October-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Management Controls Under FDA QSR and ISO 13485

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

  • 02-October-2017| 1:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

3 hours Webinar: Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 3 Hrs Live Webinar

  • 29-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Live Webinar Qualification of contract manufacturer organizations based on practical experience

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Attendees will receive “A 6 page Pre-Audit Questionnaire and a 25 page CMO audit form”

  • 27-September-2017| 02:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 60 Minute

3-hr Webinar : Untangling the FMLA, ADAAA, GINA, and Workers Compensation Laws

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

Webinar Includes : All the training handouts , certificate ,Q/A and 3 Hrs Live Webinar

  • 27-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

How to Evaluate Payroll Provider Vendors and Minimize Implementation Nightmares!

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

All companies with 50 or more employees must ensure compliance with federal, state and local regulations. It is difficult to navigate the employment law reporting

  • 27-September-2017| 12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 90 Minute

Risk Based Approach to 21 CFR 11 ER/ES & Validation of Computer Systems

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This Hands-On course will provide the attendees with both a strategic and a tactical understanding of how CSV fits into all aspects of the Life

  • 27-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Regulatory Submissions all Part of CMC

By: JERRY DALFORS ,Principal, JD Technologies.

  • 26-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Use of Electronic Health Records (EHR) in FDA Regulated Clinical Investigations

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

This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.

  • 22-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Mobile Medical Apps (Is It a FDA Regulated Device) and Cybersecurity

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

Cybersecurity is very important for moblile apps. The FDA requirements for cybersecurity in the app design will be explained

  • 19-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live webinar: International Letters of Credit

By: Jan Seal ,International Trade Consultant.

A letter of credit is one method of payment used in international trade transactions.

  • 19-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar : Compliant Use of Cloud Technologies in the Life Sciences

By: Joseph Franchetti ,FDA Quality and Regulatory Compliance Specialist.

This presentation will highlight the concerns of industry and give you the confidence you need to maintain a cloud based system in a regulated environment

  • 14-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Packaging and Labelling for Commercial and Clinical Products - 2017

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.

  • 07-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Understanding European Filing and Registration Procedures for Drug Approval

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

How to choose the appropriate pathway to drug approval in the EU

  • 06-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Regulatory Submissions all Part of 510K

By: JERRY DALFORS ,Principal, JD Technologies.

FDA BRIEFING Documents

  • 06-September-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Regulatory Perspectives on Pharmacogenomics: A Review of Key Issues Faced by FDA

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

Submission of pharmacogenomics data as part of a drug or biologic submission, impacts the approval of the submitted product. Complying with FDA requirements on the

  • 30-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Design Control Principles for Medical Device Manufacturers

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed

  • 28-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Implementing Effective Regulatory Compliance

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

This webinar will take the participant on a journey that begins with an organizational clean slate and builds all of the key pieces that are

  • 23-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live webinar: U.S. Export Documentation and Procedures

By: Jan Seal ,International Trade Consultant.

Keep current with the changes that have taken place with the export regulations including changes in 2017

  • 22-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Organizational Change Management Best Practices for Computer System Validation in Industries Regulated by FDA

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

Organizational change management is a key aspect of computer system activities involving the FDA’s guidelines on the system development life cycle (SDLC).

  • 16-August-2017| 12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 90 Minute

Live Webinar 2017-DMFs in eCTD format

By: Peggy J. Berry. ,MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official).

You will gain an understanding of contact points with the FDA throughout the lifecycle of the DMF

  • 15-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

HIPAA Audits and Enforcement — Being prepared helps prevent violations and penalties

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

HIPAA audit and enforcement programs and how they work, and discuss the areas that caused the most issues in prior audits and enforcement actions.

  • 14-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

The FDA Inspection: From SOP to 483

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections

  • 10-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Do’s & Don’ts of Poster Compliance! Your Company is at Risk for Fines & Penalties if you are not aware of the many Changes in Poster Compliance!

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

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

  • 03-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Using Microsoft Excel to Ensure Accurate Analysis, Monitoring and Training to be within required FDA Compliance – profitability

By: JERRY DALFORS ,Principal, JD Technologies.

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

  • 02-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT 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

  • 02-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Conducting a Regulatory Documentation and Training Gap Analysis in the Life Sciences

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

  • 01-August-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

3-hr webinar:Design Controls for Medical Devices

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency.

  • 31-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Live webinar Import Compliance Program for U.S. Companies (What is New!)

By: Jan Seal ,International Trade Consultant.

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

  • 27-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar 21 CFR 11 Compliance for Excel Spreadsheets

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional

  • 27-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live webinar Quality Risk Management By Steven Laurenz

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 25-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar On Conducting Internal Investigations the Right Way

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 25-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Crucial Compensation : How to Have Calm, Effective Pay Discussions with Employees

By: Wes Pruett ,Owner at HR Advisors, Leadership Coach, facilitator, HR consultant.

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

  • 24-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Customer Service Excellence: Building Service Champions

By: Marcia Zidle ,Executive and Leadership Coach.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 20-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Good Documentation Practices for FDA-Regulated Computer System Validation

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 19-July-2017| 12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 60 Minute

Live Webinar FDA Regulation, 3D Printing and Medical Devices

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

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

  • 19-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Unraveling the Mystery: Why some companies struggle while others succeed

By: Bahaa Moukadam ,Future Shaper, Certified Gazelles Coach, Advisor to Successful Leaders.

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

  • 19-July-2017| 12:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 90 Minute

Live webinar:Using Smart Phones and Mobile Devices in Healthcare — Misuse may be a HIPAA violation

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

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

  • 17-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

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

Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management

  • 12-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minute

Live Webinar Implementing the New Affordable Care Act and Discrimination Laws into Your Organization’s Wellness Program

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

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

  • 12-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence

  • 11-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Current Concepts & Challenges in Cloud Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

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

  • 11-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Unemployment Insurance: Preparing for and Managing 2017-2018 Tax Liabilities

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 10-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Process Validation: Principles and Protocols

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

This webinar explains the regulatory requirements for process validation

  • 06-July-2017| 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.

  • 05-July-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Document Control for Start-ups: Cost-Efficient and Compliant

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Document control can be a time- and paper-consuming process. To your start-up, time is a valuable commodity. So is money.

  • 28-June-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Privacy And Security: Learn From Best Practices For HIPAA Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

HIPAA, the Health Insurance Portability and Accountability Act, sets the standard for protecting sensitive patient data.

  • 27-June-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 180 Minutes

Live Webinar Equipment Validation, Tracking, Calibration and Preventive Maintenance

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment

  • 23-June-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Implementing a process for the successful Technology Transfer of drug products

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

This training will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer

  • 21-June-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Medical Devices - International Regulatory Compliance & Regulatory Affairs

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

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

  • 20-June-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Medical Device Trends for Computer Systems Regulated by FDA

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 14-June-2017| 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 60 mins Live Webinar

  • 13-June-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Risk Management - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

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

  • 08-June-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

How to Create an Export Compliance Program under the Export Administration Regulations

By: Douglas Cohen ,Senior Manager for Global Trade and Contracts, Worldwide Trade and Legal Associates.

  • 07-June-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Medical device cybersecurity following latest FDA Guidance

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 06-June-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Personnel Training to Assure FDA and ISO Compliance

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 31-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Medical Device MDR following new FDA Guidance

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 25-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Implementing a process for the successful Technology Transfer of drug products

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 18-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Letters of Credit for Importers and Exporters (TRD272D)

By: Douglas Cohen ,Senior Manager for Global Trade and Contracts, Worldwide Trade and Legal Associates.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 17-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

FDA Guidance: Medical Device Recalls By Ex FDA investigator

By: Larry Spears ,Ex FDA investigator and President at L.Spears Consulting LLC.

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

  • 17-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

An Introduction to the New EU Medical Device Regulation

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 16-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Integration of Enterprise Requirements Planning (ERP) and Legacy Systems in an FDA-Regulated Environment

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

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

  • 11-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Continuous Improvement Tools for your Quality Management System

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

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

  • 10-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinars How to Conduct a Human Factors/ Usability Validation

By: Edwin Waldbusser ,Regulatory Consultant, Med Device Advisors.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 03-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

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

  • 02-May-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar The Requirements and Responsibilities of a HIPAA Security/Privacy Officer

By: Howard Jones ,President of HJones & Associates LLC.

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

  • 26-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 26-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Harmonized Tariff Schedule Classification

By: Jan Seal ,International Trade Consultant.

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

  • 25-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Effective FDA Regulatory Inspections

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 20-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Good Documentation Practices for FDA-Regulated Computer System Validation

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

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

  • 19-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Achieving Success and Compliance in the Supply Chain

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 18-April-2017| 02:30 PM EDT | 11:30 AM PDT | 01:30 PM CDT Duration 60 Minute

Live Webinar Audit – An Essential Tool for Continuous Improvement

By: Susanne Manz ,Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc..

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

  • 18-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Quality System Management Effectiveness

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 12-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

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

  • 11-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Implementing a Quality by Design program for product development

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

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

  • 06-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Live Webinar Medical Device Trends for Computer Systems Regulated by FDA

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

  • 05-April-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar The Requirements and Responsibilities of a HIPAA Security/Privacy Officer

By: Howard Jones ,President of HJones & Associates LLC.

Webinar Includes : All the training handouts , Certificate ,Q/A and 60 mins Live Webinar.

  • 28-March-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minutes

Live webinar Supplier Management in a Compliant, Cost-Efficient Manner

By: Jeff Kasoff ,FDA Speaker, Quality and Regulatory Consultant.

Webinar Includes : All the training handouts , Certificate ,Q/A and 60 mins Live Webinar.

  • 27-March-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minutes

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

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

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

  • 22-March-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar: Best Practices in Preparation for an FDA Computer System Audit

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

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

  • 15-March-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live webinar HHS Guidance on Ransomware in Healthcare

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

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

  • 15-March-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Implementing a Risk-Based Internal CGMP Annual Audit Program

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

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

  • 14-March-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Live Webinar Proper Execution of Annual Product Reviews

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

Webinar Includes : All the training handouts , Certificate ,Q/A and 60 mins Live Webinar.

  • 01-March-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minutes

Live Webinar:-FDA Labeling Requirements

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

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

  • 22-February-2017| 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

3 ½ Hours Webinar :Harmonized Tariff Schedule Classification (Importers and Exporters)

By: Jan Seal ,International Trade Consultant.

This course will aid participants in minimizing errors in import and export under the Harmonized Tariff Schedule (HTS). It will help better protect your company

  • 01-January-2017| 11:30 AM EDT | 08:30 AM PDT | 10:30 AM CDT Duration 210 Minutes
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