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.
Recap of the Opening Plenary Session of the 2019 ISPE Global Pharmaceutical Regulatory Summit
Industry and regulators came together on 5-6 December for the 2019 ISPE Global Pharmaceutical Regulatory Summit in North Bethesda, Md. Regulators were both...
The inaugural Student & Young Professionals’ Hackathon at 2019 ISPE Annual Meeting & Expo brought together 36 students and Young Professionals from around the globe to compete in a team-oriented, collaborative, and educational challenge, to learn...