The current global pandemic has significant long-term implications for the pharmaceutical industry. The inability to perform face-to-face facility audits will accelerate regulators moving toward quality models based on metrics as key quality indicators, rather than the dominant reliance on face-to-face audits and inspections. Implementation of “virtual” audits has also increased. Equally, industry has needed to accelerate embracing change and adapt quickly, supported by the additional guidance documents issued by regulators.
Continued identification of data integrity problems prior to the pandemic raises the general concern that without audit-based oversight, some organizations may take potential advantage of the situation. The unique nature of the problems created by the pandemic and the accelerated change required to comply with travel restrictions and social distancing requirements could enable this situation. Regulatory trends and audit findings prior to and during the pandemic are particularly important as these establish a baseline of regulatory actions and sends a strong signal to industry.
Despite the global proliferation of data integrity findings, proactively looking for evidence and examples of trends and specific data integrity findings, such as components of ALCOA+, is harder than you might anticipate. For example, FDA no longer supports content-based searching of Warning Letters on their website. This means it is increasingly essential that organizations adopt a more strategic approach to finding and leveraging regulatory non-compliance data from multiple sources than in the past. Additionally, strategies based on “reacting to audit findings” are now perceived as very high risk after reviewing examples of noncompliance actions.
On Wednesday, August 26, Paul Smith, Global Compliance Specialist at Agilent Technologies presented this informative webinar with Govzilla on data integrity noncompliance trends prior to and during the COVID-19 pandemic.
What You Will Learn
- Examples of essential laboratory actions to remain compliant during the pandemic
- Recent data integrity noncompliance findings and trends
- Essential strategies to find, understand, and leverage regulatory noncompliance data
Who Will Benefit?
This session will be valuable to quality, laboratory management, and personnel with an interest in regulatory trends and audit findings in FDA-regulated industries.
To download, click here!
About the Presenter
Paul Smith is currently a Global Compliance Specialist at Agilent Technologies, a company that provides compliance services, software, consumables, and instrumentation to regulated industries. Prior to joining Agilent, he worked in a range of quality, laboratory, and management roles during the 17 years he worked in the pharmaceutical industry. For the last 17 years, he has worked in consultancy roles, monitoring regulatory trends and changes and supporting harmonization of laboratory compliance. This includes changes to pharmacopeias, supporting the development of GAMP Good Practice Guides, and monitoring regulatory actions and observations. He is a regular contributor to journals in the area of analytical instrument qualification and laboratory compliance trends.
To download, click here!
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