Investigation of Out-of-Specification Test Results

webinar-speaker   Paul Larocque

webinar-time   90 Min

Product Id: 706638

Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.

13 / Jul / 2021 - Tuesday

* Per Attendee $249

 

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703476

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

19 / Jul / 2021 - Monday

* Per Attendee $229

 

Pharmaceutical Data Integrity

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706101

Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.

19 / Jul / 2021 - Monday

* Per Attendee $199

 

Transfer of Analytical Methods according to USP <1224>

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706036

In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.

23 / Jul / 2021 - Friday

* Per Attendee $199

 

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

 

Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

webinar-speaker   Travis Austin MacKay

webinar-time   90 Min

Product Id: 702154

This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.

6 / Aug / 2021 - Friday

* Per Attendee $229

 

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 write SOP's that Avoid Human Error

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704418

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

5 / Oct / 2021 - Tuesday

* Per Attendee $199

 

Human Error Reduction in GMP Manufacturing

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704107

This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.

Recording Available

* Per Attendee $299

 

Human Error Reduction Techniques for Floor Supervisors

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706137

Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Recording Available

* Per Attendee $249

 

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

 

Basic Clean Room Technology, Operation and Contamination Control in a Nutshell

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 706142

Attend this webinar to understand the Clean Room regulations, design, classification, sources and types of particles. Learn how to create a common ground between these varying regulations and requirements. It will discuss the types of micro-organisms, routine monitoring processes, and typical mitigation steps to effective contamination control.

Recording Available

* Per Attendee $299

 

Pack of 3 Trending Courses on USP Standards

webinar-speaker   Dr. Afsaneh Motamed Khorasani,Mark Powell,Dr. Ludwig Huber

webinar-time   3 Hrs

Product Id: 706719

Recording Available

* Per Attendee $599

 

FDA Data Integrity Training: Pack of 6 Training Courses

webinar-speaker   John R Godshalk,Carolyn Troiano,Danielle DeLucy,Kelly Thomas

webinar-time   9 Hrs

Product Id: 706717

Recording Available

* Per Attendee $1299

 

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

 

Pharmaceutical Water System: Design, Testing and Data Management

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705863

In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.

Recording Available

* Per Attendee $299

 

Recording Available

* Per Attendee $1299

 

Recording Available

* Per Attendee $1299

 

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

 

 

 

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