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.

5 / Dec / 2022 - Monday

* Per Attendee $199

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

6 / Dec / 2022 - Tuesday

* Per Attendee $199

 

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

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706861

This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss why supervision is so important in reducing and preventing human error. Supervision approaches near root causes and root causes for supervision related errors and will address the main five elements to assure an error-free environment.

8 / Dec / 2022 - Thursday

* Per Attendee $199

 

The Human Error Tool Box: A Practical Approach to Human Error

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706862

This course offers practical approaches and tools to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.

10 / Jan / 2023 - Tuesday

* Per Attendee $199

 

Medical Device Change(s) and the 510(k)

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701742

This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

17 / Jan / 2023 - Tuesday

* 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.

30 / Jan / 2023 - Monday

* Per Attendee $199

 

Validation Sampling Plans

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706332

This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.

Recording Available

* Per Attendee $299

 

Project Management for FDA-Regulated Companies

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701758

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Recording Available

* Per Attendee $299

 

FDA Ambitious Regulation of Social Media and Corporate Responsibility

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.

Recording Available

* Per Attendee $279

 

Effective Systems for Change Control in the Pharmaceutical Industry

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 705002

This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

Recording Available

* Per Attendee $249

 

Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible

webinar-speaker   Charles H Paul

webinar-time   90 Min

Product Id: 706825

This instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business.

Recording Available

 

Pharma Regulatory Submissions Know how – Training Bundle

webinar-speaker   Robert J Russell,Karl M. Nobert

webinar-time   9 Hrs

Product Id: 706843

Recording Available

* Per Attendee $1299

 

Recording Available

* Per Attendee $899

 

Pharmaceutical Regulations Training Bundle for Regulatory Affairs Professionals

webinar-speaker   Joy McElroy,Karl M. Nobert

webinar-time   7 Hrs

Product Id: 706841

Recording Available

* Per Attendee $1299

 

Project Management Training for Pharmaceutical Regulatory Affairs

webinar-speaker   Pam Dellea Giltner,John E Lincoln

webinar-time   6 Hrs

Product Id: 706840

Recording Available

* Per Attendee $1099

 

Recording Available

* Per Attendee $1099

 

Recording Available

* Per Attendee $1599

 

How to Prevent cGMP Violations & Warning letters - Training for Pharma Manufacturing

webinar-speaker   Peggy Berry,David L Chesney,Mark Powell

webinar-time   8 Hrs

Product Id: 706838

Recording Available

* Per Attendee $1099

 

How to use Quality Systems and Processes - Training for Pharma Quality Managers

webinar-speaker   Joy McElroy,Dr. Ludwig Huber,John E Lincoln

webinar-time   7 Hrs

Product Id: 706836

Recording Available

* Per Attendee $1299

 

Performing Effective Management Review of the Quality System

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 704933

This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

Recording Available

* Per Attendee $249

 

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