GMP Audits – Inspection Readiness

GMP Audits – Inspection Readiness GMP Regulations Event Date 10th to 11th February 2020, Location: Budapest, Hungary OVERVIEW OF GMP AUDITS MASTERCLASS IN EUROPE Regulatory audits are a fact of life, yet companies are often worried when they receive the notification of a planned visit. This planned audit, which can be several weeks in advance or, worst case, an unannounced one often causes disruption to the day to day activities of a GMP facility. Why are we worried since we should be capable of managing and responding to Regulatory Reviews of our GMP activities? The ability of companies to be Inspection Ready enables them to manage the unexpected and also keep on top of the preparation work that often drives our actions in the last few weeks before an audit. By being proactive instead of reactive companies can minimize the disruption to day to day activities and also help reduce the severity of inspection findings since there should be no surprises. Attendance on thi...

GMP Audits – Inspection Readiness GMP Audits – Inspection Readiness  Event Date 10th to 11th February 2020, Location: Budapest, Hungary KEY TOPICS OF GMP AUDITS MASTERCLASS Recognize  the most common inspection types Avoid  mistakes and risky behaviour in relation to inspection Learn  the difference between auditing for oral solid dosage forms & sterile dosage forms Understand  how to maintain GMP in your facility Prepare  for inspection & mock audit

GMP Audits – Inspection Readiness GMP Regulations Event Date 10th to 11th February 2020, Location: Budapest, Hungary KEY TOPICS OF GMP AUDITS MASTERCLASS Recognize  the most common inspection types Avoid  mistakes and risky behaviour in relation to inspection Learn  the difference between auditing for oral solid dosage forms & sterile dosage forms Understand  how to maintain GMP in your facility Prepare  for inspection & mock audit

GMP Audits – Inspection Readiness GMP Regulations Event Date 10th to 11th February 2020, Location: Budapest, Hungary KEY TOPICS OF GMP AUDITS TRAINING IN BUDAPEST In this GMP Audits Masterclass participants will learn Overview of EU Audit types and deficiency classifications In this GMP Audits Masterclass participants will learn the Importance of Inspection/Audit readiness In this GMP Audits Masterclass participants will learn Typical areas of focus for solid dosage forms In this GMP Audits Masterclass participants will learn Typical areas of focus for sterile dosage forms In this GMP Audits Masterclass participants will learn Inspection findings In this GMP Audits Masterclass participants will learn How to stay current in respect of GMP

GMP Audits – Inspection Readiness GMP Regulations Event Date 10th to 11th February 2020, Location: Budapest, Hungary OVERVIEW OF GMP AUDITS MASTERCLASS IN EUROPE Regulatory audits are a fact of life, yet companies are often worried when they receive the notification of a planned visit. This planned audit, which can be several weeks in advance or, worst case, an unannounced one often causes disruption to the day to day activities of a GMP facility. Why are we worried since we should be capable of managing and responding to Regulatory Reviews of our GMP activities? The ability of companies to be Inspection Ready enables them to manage the unexpected and also keep on top of the preparation work that often drives our actions in the last few weeks before an audit. By being proactive instead of reactive companies can minimize the disruption to day to day activities and also help reduce the severity of inspection findings since there should be no surprises. Attendance on this tra...