ComplianceOnline

Introduction and Up-date to Relevant Guidance of Sterilizing Filtration

Instructor: Maik Jornitz
Product ID: 701111
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Sterilization training will provide valuable assistances in validating their sterilizing grade liquid filters within the pharmaceutical and biotech processes.

The talk will list relevant guidance and compliance documents of different regulatory agencies, like FDA, EMEA and supporting organizations, like PDA. Specific section of guidance are quoted and interpreted for its relevance in regard to validation, compliance with CGMP (Current Good Manufacturing Practice) and the impact for the end-user. The focus of the assessment and interpretation will be on sterilizing grade filter topics. New, in future relevant developments will be discussed.

Areas Covered in the seminar:

  • What sterilzing filter relevant guidances are available .
  • What are the different requirements.
  • How do the guidances influence validation and use of steriling grade filters.
  • What is to come in future.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their sterilizing grade liquid filters within the pharmaceutical and biotech processes. The employees who will benefit include:

  • End-users of sterilizing grade filters
  • Validation manager or specialists
  • Regulatory manager or support
  • Quality assurance manager
  • Regulatory agency personnel
  • Consultants

Instructor Profile:

Maik Jornitz, is Group Vice President Marketing at the Sartorius Stedim Biotech Inc.. With over 20 years of experience, Mr. Jornitz supports the biopharmaceutical industry on a world-wide basis, in validation, integrity testing, membrane filtration of air and liquids. As Chair-Elect of PDA, Jornitz has been part of multiple PDA task forces, committee member and chair. He is also member of ISPE, DIA, ASTM and ALSAC. Jornitz is the author and co-author of close to 80 professional papers, 8 books and 6 book chapters. As faculty member of PDA TRI he trains industry members and regulators on a frequent basis. He holds several filter related patents and is the founder of Bioprocess Resources LLC.

Mr. Jornitz received his Diploma in Bioengineering at the College for Advanced Technology in Hamburg, Germany and accomplished his PED at the IMD Business School, Lausanne, Switzerland.

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