Training & seminars
Module 8 – GxP and Quality Auditing Practices
21 November 2016
Where
The Boulevard St Giles Premier Hotel<br />Mid Valley City<br />Lingkaran Syed Putra,<br />59200 Kuala Lumpur, Malaysia
Aim: To provide an introduction to auditing principles and practices , and to develop a broad understanding of the requirements and techniques for planning, conducting and reporting quality audits applicable to manufacturing systems for drugs, biologics and devices.
Day 1
AM ►Critical role of quality audit in GxP compliance & improvement
PM ►GxP audit schedule, managing regulatory audits in an effective manner, what to expect from GMP licensing audits
Day 2
AM ►The role of supplier audits for actives, excipients and components in Vendor management
PM ►Documents, records & data for effective audits.
Day 3
AM ►Four fundamental steps of auditing explained in detail, tips on how to manage & facilitate audits in a constructive manner
PM ►Utilisation of risk management in relation to prioritising audits
Download the brochure and registration form.