Using a Learning Management System (LMS) to Develop Pharma Training Curricula

By: Michael Esposito ,Principal at TrainReach Consulting, LLC.

Development of job position curricula in the Pharmaceutical industry

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

Creating and Maintaining an Effective and Efficient Technical Training Program

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

GMP regulations on the training topic.

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

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats

By: Michael Esposito ,Principal at TrainReach Consulting, LLC.

Problem of counterfeit drugs and suggest ways to combat it

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

Harmonized Tariff Schedule/Schedule B Classification

By: Martin Ken Behr ,Customs and International trade lawyer.

Must understand how The Schedule B (also known as the Statistical Classification of Domestic and Foreign Commodities

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

How to prepare for and host a FDA inspection and respond to 483’s

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

How to respond to 483s and warning letters

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

Understanding the FDA Compounding Pharmacies Guidance Document

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

Why the Compounding Pharmacy Guidance document is being implemented

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

Automating Assays for Clinical Diagnostics

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

Steps needed to transfer, validate and maintain an automated assay in the laboratory

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

How to Detect Lack of Data Integrity

By: Ron Snee ,Founder and President of Snee Associates.

Data integrity sources and introduces the assessment of “data pedigree”

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

Bad Standard Operating Procedures (SOPs) = Bad Training: Garbage In, Garbage Out

By: Michael Esposito ,Principal at TrainReach Consulting, LLC.

How to maximize this connection to improve the quality of both SOPs

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

Process Validation – Principles and Protocols

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

Definitions and application of applicable terminology

  • 16-July-2019| 03:00 PM ET | 12:00 PM PT | 04:00 PM CT Duration 60 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

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

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

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

Latest draft guidance from the FDA in regards to Quality Metrics

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

Monitoring Product Quality, Process Performance and Enabling Continued Process Verification – A Systems Approach

By: Ron Snee ,Founder and President of Snee Associates.

Disciplined and structured QbD approach to achieve this objective

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

10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love

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

Understanding of the regulatory expectations for Data Integrity

  • 18-July-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.

Traceability issues critical to the appropriate location

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

Learn How Blockchain Will Become the Basis for an Integrated Food Safety System (IFFS)

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

How risk levels and probable supply chain failure points can be calculated

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

Non-conforming Material and Failure Investigation

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

Confusing regulations and effectively deal with non-conforming material

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

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

HCPCS code billing for medications-find what payers are requiring to pay these codes

By: Stephanie Thomas ,Billing Director, CE Medical Group.

Simplify the process by submitting claims correct the first time

  • 23-July-2019| 01:30 PM ET | 10:30 AM PT | 12:30 PM 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

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

SOP's for Bioanalytical Methods Validation

By: Todd Graham ,Managing Partner, Delevan Street Biosciences.

Advantages and challenges in each class

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

Understanding the FDA Aseptic Processing Guidance Document

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

How final drug product is aseptically processed, pharmaceutical companies can implement

  • 25-July-2019| 11:00 AM ET | 08:00 AM PT | 10:00 AM CT Duration 60 Minutes

Quality Control of Microbiological Media, Reagents and Test Kits

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

Practical QC approach for in-house prepared and/or commercially purchased media

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

ISO/IEC 17025:2017 Section 8 – Management System Requirements

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

Changes in the standard and what you must do to update your QMS

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

Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada

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

General procedure for the preparation and documentation of the Annual Product Quality Review

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

Supervising a Human Error Free Environment: You can do a Lot More than you Think

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

Human behavior CAN be manipulated reducing the likelihood of these occurrences

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

Responsibilities of the Carrier Under the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

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

Carrier transportation operations personnel are required to take this and the subsequent two training sessions.

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

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

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 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

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

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
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