Webinar Series Basics of EU GMP-/FDA-compliant Sampling: Statistical Aspects

Wednesday, 24 June 2020 14.00 - 15.30 h

Course No. 18004

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Speakers

Dr. Raphael Bar

Dr. Raphael Bar

BR Consulting

Important: Deadline is 12 noon on 21 June 2020 You will find all webinars of this series in this overview

Background

Sampling of materials is one of the most important processes in pharmaceutical companies. Regulatory agencies require a sampling plan that utilizes basic elements of statistical analysis or provides a scientific rationale for taking a representative sample according to the lot size. According to the revised Chapter 6 of EU GMP Guide, the sampling plan used should be appropriately justified and based on a risk management approach. Representative samples should be taken and recorded in accordance with approved written procedures. FDA requires as well in the Code of Federal Regulations (21 CFR Part 211.84) that sampling should be done upon statistical criteria.

Target Group

This webinar is directed at all those employees from quality control units and production units in the pharmaceutical industry who are competent or responsible for sampling, testing and release of starting materials (APIs and excipients), packaging materials (primary and secondary) as well as finished pharmaceutical products. This course is also of interest to personnel from quality assurance and to those employees from API, excipient or packaging material suppliers who want to get a comprehensive yet compact overview of the requirements on sampling.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Webinar Series Basics of EU GMP-/FDA-compliant Sampling: Statistical Aspects

Seminar Programme as PDF

This webinar will give you a comprehensive overview of the statistical aspects of sampling.

The following topics will be covered:
  • Sampling attributes vs. sampling by variables
  • Basic sampling distributions (binomial, poisson, normal distribution)
  • √N rule
  • Charting and trending
  • Non-conformities and non-conforming items

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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