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As per available reports about 36 Relevant Journals,40 Conferences are presently dedicated exclusively Pharmaceutical audits and about 203 Articles are being published on audits
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of organization's quality management system and is a key element in the ISO quality system standard, ISO 9001.Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria. Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem area and includes Quality Control, Quality Assurance, Validation, Contract & Sterile/Aseptic Manufacturing, Storage, Distribution, Transportation, Formulation Development, GMP in Food Industry
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Scope and Importance:
Quality audits can be an integral part of compliance or regulatory requirements. One example is the US Food and Drug Administration, which requires quality auditing to be performed as part of its Quality System Regulation Several countries have adopted quality audits in their higher the UK, the process of quality audit in the education system focused primarily on procedural issues rather than on the results or the efficiency of a quality system implementation Audits can also be used for safety purposes. Evans & Parker (2008) describe auditing as one of the most powerful safety monitoring techniques and 'an effective way to avoid complacency and highlight slowly deteriorating conditions', especially when the auditing focuses not just on compliance but effectiveness.
Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry. A GMP Compliance Audit will allow you to avoid delays in bringing product to market due to not passing a GMP audit. The cost and time associated with regulatory re-audits if an audit outcome is not satisfactory can also be avoided or minimised.
Market Analysis:
The market research available can provide investors and analyst credible information on the direction of pharmaceuticals and pharmaceutical industry is one of the largest and most advanced among the developing countries and it is 3rd largest pharmaceuticals market by 2020 and the pharmaceuticals industry accounts for about 2.4% of the global pharma industry by value and 10% by volume.
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This page was last updated on January 15, 2025
