Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704086

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

26 / Jul / 2021 - Monday

* Per Attendee $299

 

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

webinar-speaker   Ginette M Collazo

webinar-time   60 Min

Product Id: 704210

This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.

10 / Aug / 2021 - Tuesday

* Per Attendee $229

 

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

17 / Aug / 2021 - Tuesday

* Per Attendee $229

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

Root Cause Analysis - The Heart of Corrective Action

webinar-speaker   Betty Lane

webinar-time   75 Min

Product Id: 703391

This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.

Recording Available

* Per Attendee $299

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705130

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Recording Available

* Per Attendee $299

 

Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 701142

This Quality management training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive Maintenance.

Recording Available

* Per Attendee $249

 

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703875

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

Recording Available

* Per Attendee $299

 

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704314

This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.

Recording Available

* Per Attendee $299

 

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703000

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

Recording Available

* Per Attendee $299

 

Properly Investigating and Remediating OOS Results

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 704351

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Recording Available

* Per Attendee $299

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

Building a Compliant Laboratory - From Foundation to Business Excellence

webinar-speaker   David Husman

webinar-time   90 Min

Product Id: 706396

Everyone struggles with getting their laboratory into compliance. Learn how to build a compliant laboratory from starting with a good foundation to implementing for Business Excellence. Dr. Husman’s presentation will walk you through the process and steps needed to ensure a compliant laboratory is built or rebuilt for business excellence.

Recording Available

* Per Attendee $299

 

Risk Management - A Process Flow Approach to Converting a Guidance into an SOP

webinar-speaker   David Husman

webinar-time   60 Min

Product Id: 706414

Attend this webinar to learn how to translate a new guidance or regulation into a working process, and how to use process flow, techniques and templates to develop procedures on your own. The webinar will provide you with a working SOP for Risk Management.

Recording Available

* Per Attendee $299

 

The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 706183

Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments. There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.

Recording Available

* Per Attendee $299

 

Deviation Management - Why Have We Not Solved the Problem?

webinar-speaker   David Husman

webinar-time   60 Min

Product Id: 706413

This webinar will discuss the causes for failure in our deviation systems and recommendations to successfully take a different approach that results in problems finally being solved.

Recording Available

* Per Attendee $299

 

Bioanalytical Methods Validation

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 701769

This training on bio-analytical methods validation will help you to understand the FDA and EMA guidance for Instrumental, ligand binding and cell-based assays and also review of recent 483s impacting validation.

Recording Available

* Per Attendee $299

 

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

webinar-speaker   Karl M. Nobert

webinar-time   90 Min

Product Id: 703313

This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.

Recording Available

* Per Attendee $349

 

Data Integrity - It's Not New and So Much More than Just Computers

webinar-speaker   David Husman

webinar-time   60 Min

Product Id: 706410

This webinar will discuss the recent attention regulators have placed on data integrity and show how the requirements are not new. The sources of data issues go far beyond the laboratory and are not just found in computer/electronic systems.

Recording Available

* Per Attendee $299

 

Validation of HPLC/UPLC Methodologies

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705291

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Recording Available

* Per Attendee $249

 

 

 

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