Remote audits – The new normal

By: Helen Kargaryani, Global Head of Quality at NDA Group.

In this whitepaper, Helen provides tips and good practices for remote audits as an alternative method to conducting traditional on-site audit.


The COVID19 pandemic is presenting unprecedented challenges to healthcare, the pharmaceutical industry’s supply chain and the ways in which companies operate “business as usual”. Quality and compliance activities have been particularly affected, areas that are crucial to ensure the long-term safety and efficacy of treatments.

Quality audits and inspections are essential aspects of the checks and balances in a pharmaceutical Quality Management System (QMS). With new guidance’s, constrained travel and limited access to buildings, suppliers, records and people, manufacturer, regulatory and quality personnel must now explore methods and techniques to evaluate quality and compliance in light of these restrictions. To meet these challenges, regulatory agencies and companies alike are adapting to the situation, relying heavily on remote mechanisms to continue delivering lifesaving medicines and products globally.

In this whitepaper, we will provide tips and good practices for remote audits as an alternative method to conducting traditional on-site audit. This paper will also cover circumstances in which remote audits may be necessary and preferable to an on-site audit. Furthermore, we will discuss potential challenges and benefits when auditing remotely and how to adapt your processes and systems to prepare your company for remote audits.

Click to the full article
 

Contact us to learn more about how our integrated team can provide advice and support into your drug development plan.

 

 

 

NDA invited by United Arab Emirates government at PV Conference

Shelley Gandhi, NDA’s Head of Pharmacovigilance services, has been invited by the United Arab Emirates government to speak at their 3rd National Pharmacovigilance & Risk Management Conference on 29th and 30 May, titled: “New Pharmacovigilance Legislation, Implementation and Risk Management Assessment Industrial Perspective”. The main objective of the conference was to inform the pharmaceutical companies to report ADR and submit their PSUR to the national authority in UAE in order to minimise medication error and adverse drug reactions. Shelley spoke on a number of topics, including ICSRs & MedDRA, Signal Detection and Management, PSUR (PBRERs) and co-chaired shared panel sessions, to an audience that included physicians, pharmacists and Pharmacovigilance officials and specialists.