How do you build the quality that is essential to all processes and products? Training auditors to conduct good audits is one way. These are some critical skills auditors must know to conduct successful audits:
Using audit trails and checklists to prepare and conduct audits
Knowing what points are often missed during an inspection
Effectively evaluating audit and report findings
Identifying critical components for a good audit report
Understanding the concepts behind compliance auditing while knowing global cGMP concepts and regulatory requirements related to auditing
Tools such as checklists also can help the auditor focus on key items. With proper training, auditors can find issues early, when they may be more easily corrected—and long before they become unmanageable or systemic. ISPE has a popular course to provide this training, called GMP Auditing for the Pharmaceutical Industry.
The ISPE APQ Assess, Aspire, Act and Advance Framework will be complemented with an OPEX Benchmarking and ICH Q10 maturity assessment tool specifically developed for use with the APQ program by the University of St.Gallen, Switzerland. Used in conjunction with the APQ self-assessment tools for...
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
As we enter the new year, this is the perfect time to make the 2021 ISPE Aseptic Conference part of your personal professional development plans. The virtual conference will allow participation from across the globe with no risk to pandemic exposure. The three-day format with shorter sessions will...