GMP for Biological and Biotechnology Products Training

Course Descriptor

Our Biotech training course discusses and interprets the cGMP requirements for each step involved with process development, validation, control, auditing, and effective quality assurance (QA) and quality control (QC).  We run process simulations and have detailed discussions that promote understanding about risk assessment, deviation investigation and batch dispositioning.  This course also provides a unique insight into assuring GMP for biological products when working alongside experts in the field across a complex process train.

GMP for Biological and Biotechnology Products Training

SKU: GMP-for-Biological-and-Biotechnology-Products-Training Category:

2,900.00

Dates:
  • 14/07/2020 - 17/07/2020
Fee:
€2900
Suitable for:

This course is designed to support EU Qualified Persons as part of their QP application or as a valuable, highly focused continuing professional development event.  NSF designed the course to give production, QA, QC and technical services staff detailed insight into the challenges of producing and testing biotech and biological pharma products.

Who should attend

This course is designed to support EU Qualified Persons as part of their QP application or as a valuable, highly focused continuing professional development event.  NSF designed the course to give production, QA, QC and technical services staff detailed insight into the challenges of producing and testing biotech and biological pharma products.

Key topics covered

The subject matter this course covers includes:

  • The key design, controls and monitors associated with the common biotech process steps
  • The basic science and typical process controls associated with producing a high quality biological or biotech drug substance
  • An introduction to how quality is assured across the bioprocess and the insights/limitation of QC testing
  • The benefits and pitfalls of subcontracting key steps in the bioprocess
  • A summary of current hot topics in this field in terms of regulatory censure, GMP observations and trends
  • How to audit a biological or biotech facility
  • Guidance on the key concerns when acting as an EU QP or QA/production/technical services professional in this field

Learning outcomes

On completion of this course, delegates will know and understand:

  • The common stages in the mammalian and bacterial bioproduction processes
  • How to verify the effectiveness of each bioprocess stage via online and offline monitoring and testing
  • The critical challenges associated with bioprocessing in terms of vulnerability, risk assessment and process control
  • How the pharma quality system must be designed around the requirements of the biomolecule
  • Audit bioprocesses, how they are designed and controlled, what key documentation is generated and how an effective product dispositioning system is set up (taking into account common process deviations or cGMP deficiencies gleaned from real-life experience in the field)

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