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

Implementation and Management of GMP Data Integrity

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

Data integrity is assuming greater importance in CGMP for US FDA regulated industry

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

Mental Illness, ADAAA, and the Workplace: Taking Responsibility as an Employer

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

Physical and Mental Health

  • 22-August-2018| 11:00 PM ET | 08:00 AM PT | 10:00 PM CT Duration 90 Minutes

Adult Bullying in the Workplace: 7 Strategies to Prevent & Stop it

By: Lyman Montgomery ,President and CEO.

There also is an “imbalance of power.”

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

Getting the Right People on the Bus (How to Attract and Hire the Best)

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

Don’t suffer from “Bad Hire Nightmares”

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

Live Webinar Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

This webinar highlights some of the potential uses of RWD, and describes the factors that FDA considers when evaluating whether specific RWD is of sufficient

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

Latest FDA thinking on deciding when to Submit a 510(k) for a Change to an Existing Device - FDA's Final Guidance

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

Prepare industry for further 510(k) changes in the future

  • 04-September-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Analytical Methods Validation for FDA Compliance

By: Angela Bazigos ,CEO Touchstone Technologies Silicon Valley.

To enhance Analytical Method Validation

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

Analytical Method Validation and Transfer

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Hands-on” knowledge of the method validation process

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

Stay Interviews: A Powerful Employee Engagement and Retention Tool

By: Marcia Zidle ,Executive and Leadership Coach.

“why are you leaving?”

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

Is Your Software 510k Ready

By: Nancy Knettell ,Founder and Principal at Software510, LLC.

One of the main reasons that submitting a 510K for Software Enabled Medical Devices or Software as a Medical Device can fail to get

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

"The Complexity & Interplay Among the ADAAA, FMLA, and Worker’s Comp (WC): How Do They Work Together—Or Not?: ” Live Webinar

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

The webinar addresses laws that HR is responsible for upholding

  • 07-September-2018| 03:00 AM ET |12:00 AM PT | 02:00 AM CT Duration 90 Minutes

What to do if you receive a FDA-483, Inspectional Observations Form

By: Elvia J Cervantes ,Owner at Juarez FDA Auditing & Consulting Services Inc..

483 if there is clear communication with the Investigator

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

How to Effectively use Pre-Hire Assessments for Improved Employee Selection

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

Do you feel 100% confident that you are hiring talent

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

Unintentional Workplace Retaliation is Still Expensive! And the Truth of the Complaint Doesn’t Really Matter!.

By: Sheila Krejci, M ED ,Sheila Krejci, M ED, author, master facilitator and consultant at Sheila K Consulting, Inc..

And the Truth of the Complaint Doesn’t Really Matter!

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

Mexico Procedures and Documentation Webinar

By: Jan Seal ,International Trade Consultant.

Criminal penalties imposed by each country's Customs

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

Live Webinar How to conduct Annual Product Reviews to achieve GMP Compliance

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

Learn how to write APRs

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

HIPAA, 42 CFR Part 2, and Substance Use Disorder Information — Consents, Controls, and Conflicts in the Rules

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

This session focuses on the issues of managing health information when it may involve substance use disorder treatment information. HIPAA allows a number of

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

Implementing a Robust Supplier Management Program

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

A robust, yet efficient

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

Auditing for Microbiological Aspects of Pharmaceutical Manufacturing

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

Microbiological aspects of manufacturing

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

Criminal Background Checks in the Hiring Process

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

Employees are likely to be honest, reliable

  • 27-September-2018| 03:00 AM ET |12:00 AM PT | 02:00 AM CT Duration 60 Minutes

Food Recall Management

By: Michael Brodsky ,Lead Auditor, Canadian Association for Laboratory Accreditatio.

Unsafe or violative food product

  • 28-September-2018| 01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 60 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

Establishing a Robust Data Integrity Program

By: Kelly Thomas ,Vice President, Americas Quality Operations at Stallergenes Greer.

Data over its entire life-cycle

  • 03-October-2018| 12:00 AM ET | 9:00 AM PT | 11:00 AM CT Duration 90 Minutes

Webinar HR Metrics & Analytics 2018: Update on Strategic Planning, Application Activities and Operational Impact

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

Since HR metrics can assist your organization identify weaknesses and failures in its human resource management and employment practices compliance activities, your organization's selection and

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

On boarding is NOT orientation - How to improve the New Employee Experience

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

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

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

Risk of Objectionable Microorganisms in Bio-Pharmaceutical Manufacturing

By: Carl Patterson, M.S. ,Associate Manager, Quality Control.

Objectionable microorganisms

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

Computer System Validation

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

Testing, based on risk

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

What to do if you are told by the Agency that your response to the FDA 483 is inadequate

By: Elvia J Cervantes ,Owner at Juarez FDA Auditing & Consulting Services Inc..

Firm should assess the 483 issued

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

CGMP Inspections / Auditing -- Internal and External

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

Past “good” inspections are no indication of future inspection

  • 17-October-2018| 01:00 PM ET | 10:00 AM PT | 12:00 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

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 Minute

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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