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Booklet Bundle (eBooklets)

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Price: USD ($) 137.00

VAT on Electronic Books is chargeable in the UK and EU. Please see the 'Booklet Terms and Conditions' for further details.

New for 2020, the RQA PDF Booklet Bundle allows the opportunity for anyone to buy the PDF library of booklets that the RQA sell. You will receive a link to the 27 digital booklets that you can download at your leisure. Build your own library of eBooklets written about the GxPs and Quality in general.

eBooklets you will receive access to are:

A Monitor’s Guide to Investigator Site Audits

A Practical Guide for the Good Laboratory Practice Study Director

A Practical Guide to GLP Quality Assurance

A Practical Guide to Good Laboratory Practice in the Analytical Laboratory

Auditing Computerised Systems

CAPA: Effective Approaches to Improvement

Comparison of Pharmacovigilance Regulations in Europe and Japan

Computerised System Validation

Electronic Standard Operating Procedures

Good Clinical Laboratory Practice (GCLP)

Good Clinical Practice Regulatory Authority Inspections

Guidelines for Quality in Non-Regulated Scientific Research

Guide to the Role and Responsibilities of GLP Management

Hosting an External GLP Inspection

Investigators' Guide to Investigator Site Audits

Management of the Training and Competency of Personnel in GxP and Research Environments

Management Review

Medical Devices Regulation Booklet

Pharmacovigilance Agreements (PVAs): Guidance on the Quality Oversight and Operational Aspects

Pharmacovigilance Auditing

Quality Assurance in Pharmaceutical Due Diligence

Quality Risk Management

Quality in Research

Remote Audits and Inspections of Pharmacovigilance Systems - A Guide for Auditors and Auditees

The FMEA Toolkit

The Role of QA in Outsourcing

The Role of the Monitor in Veterinary Clinical Studies

The Quality Systems Guide is also included in the download links but can be accessed through logging into the website (or registering if you have not got an account with the RQA).

As part of your purchase, you will also receive access to a webinar recording by the authors of the Remote Audits and Inspections of Pharmacovigilance Systems - A Guide for Auditors and Auditees eBooklet.

 

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