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

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

Costs

ECA-Member: EUR 199,--
Non ECA Member: EUR 249,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Raphael Bar,  BR Consulting, Israel

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

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

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