Core Processes in the Pharmaceutical Laboratory: EU GMP-Compliant Sampling and Handling of Substances

Frank Stein
Jul 13, 2020 - 01:00 PM EST
Starting at

$249


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Description: 

Complying with good manufacturing practices (GMP) is mandatory for your drug’s success – sampling, testing and packaging materials all need to meet stringent regulatory standards.

Set yourself up for EU success with the webinar, Core Processes in the Pharmaceutical Laboratory: EU GMP-Compliant Sampling and Handling of Substances.

Our expert in the implementation of GMP standards in the EU will guide you through the planning and execution of materials sampling and testing to ensure your compliance. These steps are the first links in the chain of quality control. Mistakes made during sampling, for instance, will put the wisdom of all subsequent manufacturing steps in question and cannot be eradicated or made up for later. Enroll for the webinar that clarifies regulatory requirements, methodological principles, and practical recommendations to help you ensure the quality of your sampling and testing program as well as the finished drug. Ensure that your teams are aware of and are following quality standards that will ultimately help your end product’s results.                                                                                   

This webinar will include practical and detailed instructions, illustrations, examples, tables, and checklists enabling you to quickly familiarize yourself with all of the steps of manufacturing best practices:

 

  • Batch sampling principles and requirements
  • Factors influencing sample selection
  • Qualifications and training of people doing the sampling
  • Special requirements for microbiological sampling
  • Risk assessment for sampling
  • The two classes of drug substances — reference standards and reagents

Register today to help your team get clarification on regulatory requirements, methodological principles and practical recommendations to ensure the quality of your sampling, testing program, and finished drug.

 

Key Report Highlights: 

  • The necessary equipment to ensure a representative sample
  • Materials you must sample and what factors you must consider
  • Factors influencing the sampling process as part of risk-assessment plans
  • Basic rules for ensuring that representative samples are taken
  • Documentation requirements
  • Proper storage and shipment of samples
  • Checking on substances’ suitability and intended use
  • Ways to characterize and qualify substances
  • Requirements for storage and shelf life
  • Questions likely to arise during an audit

 

Who Will Benefit

  • Quality Management Staff
  • Regulatory Affairs Personnel
  • Logistics and Supply Staff
  • Packaging and Distribution Department Personnel
  • Lab/testing Staff

 

Webinar Events
Attend Live Webinar
Jul 13, 2020 - 01:00 PM EST

Duration: 90 Minutes

Single Attendee


Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version


Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version


Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Frank Stein, Senior Expert Medical Devices

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.


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