This course discusses the need for quality documentation of events that occurred during the crisis that are linked to significant risks and issues that matter. You will review important actions and documentation between various stakeholders (read: sites and sponsors, CROs and sponsors, etc.) which must happen to ensure deviation identification, root cause analysis (RCA), and Corrective and Preventative Actions (CAPA) are handled in a compliant fashion.
This 90-minute seminar will use the guidance provided by ICH Q2 as a foundation and go beyond to show you how to best prepare and execute your methods validation strategy.
Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections.
With the recent increase of job knowledge deficiencies being cited in regulatory inspections – especially in the areas of data integrity and sterile product manufacturing – training and qualification of personnel is becoming increasingly important to inspectors. Learn to define and understand the regulatory expectations around training and training systems in this webinar.
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