4-Hour Virtual Seminar - Batch Record Review and Product Release

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

A strong batch record review system is essential in order to properly document

  • 20-August-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 240 Minutes

How to Perform a Thorough Root Cause Analysis and CAPA Development

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

Systematic approach that utilizes quality tools to objectively identify factors

  • 21-August-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 180 Minutes

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

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

Import and export process for unapproved and approved medical devices

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

Pharmaceutical Contamination and Food Safety

By: Dr. John M. Ryan ,Quality assurance administrator.

A basic understanding of pharmaceutically contaminated foods is critical to any food safety program

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

Quality is not an Organization

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

What does Quality mean to you?

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

Secrets for Writing Excellent SOPs (Standard Operating Procedures)

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

Structure your QMS and develop accurate

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

The Influence of recent FDA and USP activities on Test Method Validation

By: John G. Lanese ,President at The Lanese Group, Inc.

Lifecycle approach to test method validation

  • 03-September-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 120 Minutes

The Enigma of a Healthy Diet (Produce Safety)

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

The risks associated with consuming raw produce and the limitations

  • 04-September-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 60 Minutes

Cybersecurity Practices for Health Care Organizations — Cybersecurity Act Task Force Recommendations

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

Learn how Cybersecurity is different from other kinds of security

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

Best Practices for Preparing for an FDA Computer System Validation Audit

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

Current trends in compliance and enforcement that can help in preparation for an FDA inspection or audit

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

HIPAA Audit and Enforcement Update — Changes to Penalties and Latest Decisions

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

Enforcement actions taken by HHS and state Attorneys General to illustrate

  • 17-September-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 180 Minutes

Carrier Food Safety Problems That May Occur during Transportation (FDA-FSMA)

By: Dr. John M. Ryan ,Quality assurance administrator.

Adulteration during loading, unloading and in-transit operations

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

Artificial Intelligence (AI) in the Food Supply Chain

By: Dr. John M. Ryan ,Quality assurance administrator.

Current trends and products coming your way regardless of where you sit in the food supply chain

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

3-Hour Virtual Seminar on CAPA for Medical Devices

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

How to streamline and monitor your process to ensure compliance and improved performance

  • 18-September-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

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

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

How to determine whether your app is a medical device

  • 19-September-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 60 Minutes

Process Validation General Principles & Practices – Integrating the FDA and EU Guidance; ICH Q8, ICH Q9, ICH Q10 and Quality Metrics

By: John G. Lanese ,President at The Lanese Group, Inc.

ICH guidance documents, US inspectional guidance and how they relate

  • 23-September-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 120 Minutes

3-Hour Virtual Seminar on Human Error Reduction in the Manufacturing Floor

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

Practical approaches and models to address human performance issues in GMP

  • 24-September-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 180 Minutes

Understanding Cleanroom Microbiology – Building A Foundation For Compliance

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

Contamination control and clean room management

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

Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error

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

How in sterile compounding, aseptic technique is contributing to the prevention

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

Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products

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

What is a combination product? What are some examples of combination products?

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

GxP/GMP and its Consequences for Documentation and IT Systems

By: Eleonora Babayants ,Galaxy Consulting Founder and President.

Documentation is a critical tool for ensuring GxP/GMP compliance

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

HIPAA Security Rule Priorities and Challenges — What’s New and What to Focus On in Managing Risks

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

Challenges of HIPAA Security Rule compliance

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

Moving from GMPs to the Pharmaceutical Quality System

By: John G. Lanese ,President at The Lanese Group, Inc.

Firm must implement to be compliant with the CGMPs

  • 03-October-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 120 Minutes

Developing an Effective CAPA Management and Root Cause Analysis System

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

Develop CAPAs pertaining to longer term projects

  • 08-October-2019| 11:00 PM ET | 08:00 AM PT | 10:00 AM CT Duration 180 Minutes

Environmental Monitoring Investigations

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

Comprehensive report the inspector is looking

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

Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

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

Best practices and strategic approach for evaluating computer systems

  • 15-October-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Standardizing Transportation Procedures to Control Food Safety and Quality

By: Dr. John M. Ryan ,Quality assurance administrator.

Improved food safety during transportation processes.

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

USDA Final Genetically Modified Organism (GMO) Label Rule

By: Dr. John M. Ryan ,Quality assurance administrator.

Food manufacturers are required to “prominently’ display clear label information

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

Emerging Issues in Food Safety, Locally. Nationally and Globally

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

Complexity of providing safe food and examine the factors that impact on microbiological food safety

  • 22-October-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 60 Minutes

Handling OOS Test Results and Completing Robust Investigations

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

Detection an out-of-specification result to informal and formal laboratory and batch investigations

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

APPLYING COMPUTER SYSTEM VALIDATION TO MOBILE APPLICATIONS

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

Computer system validation can be applied to mobile applications

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

Risk Management of Source Water used in the Food Industry

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

The limitations of how potability is currently defined and examine options for mitigating

  • 13-November-2019| 12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 60 Minutes

How to write SOP's that Avoid Human Error

By: DR. Ginette M. Collazo ,Owner - Industrial/Organizational Psychologist.

Development to formats designed for human error reduction

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

3-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance

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

Current trends in cybersecurity threats to medical devices

  • 04-December-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes
Back to Top