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

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

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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
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