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GMP Audits – Inspection Readiness

GMP HACCP Training

GMP Regulations Event Date 19 -20 March 2020, Location: Berlin, Germany

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 training course will provide background information on how to improve your company’s inspection readiness and assist in the improvement of your GMP systems.

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

Registration Fee


€2496


Per Participant


About Berlin, Germany

Berlin, Germany’s capital, dates to the 13th century. Reminders of the city’s turbulent 20th-century history include its Holocaust memorial and the Berlin Wall’s graffitied remains.

You may also be interested in our Risk Based Inspection Masterclass

We also organize In-house training session on this topic, so if you are looking for In-house training in Process Hazard Analysis then click here. We Deliver In-house training for Process Hazard Analysis in all countries and all time zones.

Start Time

9:00 am

March 19, 2020

Finish Time

5:00 pm

March 20, 2020

Address

Berlin, Germany

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