Richard L. Chamberlain
Owner, ECS, LLC
Richard Chamberlain's experience includes consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation. He has also managed large-scale clinical projects including development of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs.

Apart from these Mr Chamberlain has taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems; assisted in the development and validation of numerous computerized systems in all GxP environments; assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management and Compliance to Regulations. He is also familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs.
Upcoming Webinar
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Recorded Webinar
Clinical Trial Cost Estimation
In this webinar, we will cover ways to structure the trials so that it is possible to assign cost estimates to the necessary resources over the life of the trial and then estimate the necessary costs by month, year, and total. We will discuss where some of the problems are in getting reasonable estimates, where they can go wrong during the trial and some ways to manage them.
Recorded Session Get life time access for one participant with download option!

Best Practices for Project Management of Clinical Trials
This online training course will focus on the basic principles of project management and how they can be applied to best meet the needs of your clinical trials. You will take away a set of project management skills and techniques that can be immediately put to use. This is designed for biotechnology/pharmaceutical/medical device professionals who are involved in managing clinical trials and are looking to learn more about the basic project management process and how it might apply to their tasks.
Recorded Session Get life time access for one participant with download option!

Implementing Validation and Qualification - Annex 15 and FDA Requirements
In this webinar, we will cover the role Annex 15plays in Validation and Qualification. We will discuss other related documents that provide for other aspects of what Annex 15 is covering including FDA requirements. The subject of Validation applies to chemical processes, manufacturing processes, computer processes, product approval processes and others. The tools used for validating these processes are quality management, project management, risk management and product life cycles.
Recorded Session Get life time access for one participant with download option!

Best Practices for Communication between IND Sponsors and FDA During Drug Development process
The key learning objective of this webinar is to introduce participants to recommended practices used by investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs. Effective communication with FDA is critical in successfully bringing any therapeutic product to market. However, communication includes much more than the written regulatory submission. Effective communication in all its forms must be concise, carefully considered, and reviewed to achieve the desired outcome.
Recorded Session Get life time access for one participant with download option!

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Reduce the Occurrence of 483s
This webinar will discuss developing procedures for meeting Part 11 and Annex 11 requirements; Standard Operating Procedure for systems development and maintenance; Standard Operating Procedures for step-by-step activities; measure quality and demonstrate compliance to 21 Part 11 and Annex 11; and produce quality records.
Recorded Session Get life time access for one participant with download option!

Creating Effective SOPs for Regulatory Compliance
This webinar will discuss developing procedures for meeting quality and compliance requirements; Standard Operating Procedure development and maintenance; Standard Operating Procedures for step-by-step activities; measure quality and demonstrate compliance to regulatory and other business requirements and produce Quality Records.
Recorded Session Get life time access for one participant with download option!

IRB and Other Committees
Many Hospitals and Clinics today are looking for ways to increase revenues. One way is for them to do more clinical trials. In order to do this they must prepare their staffs to be ready to do clinical trials. This is the first in a series of training sessions intended to do that.
Recorded Session Get life time access for one participant with download option!

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