ECA Certified Biotech Manager

Due to the specifics in biotechnology, fulfilling the regulatory requirements in the manufacture and quality assurance of biotech products is a tremendous challenge, and industry as well as authorities are constantly treated with new and expected changes in the regulatory guidelines.

ECA stays abreast of these changes. The Certification Programme “ECA Certified Biotech Manager” provides you with the opportunity to acquire the necessary knowledge and qualification to fulfil the current requirements in GMP for pharmaceutical Biotechnology.

Courses and Conferences acknowledged

To receive the certificate, the applicant must attend three out of the following courses/conferences. After attending the third course, the applicant obtains the certificate “ECA Certified Biotech Manager”.

  • Protein Analytics
  • GMP for Advanced Therapy Medicinal Products (ATMP)
  • Annex 2 & Co. – GMP Compliance for Biopharmaceuticals
  • Bioassays and Bioanalytics
  • Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
  • Pharmaceutical Biotechnology for Non-Biotechnologists
  • GMP for Vaccine Manufacturers – Current regulatory requirements and practical implementation
  • Leachables and Extractables
  • Blood and Plasma – Audits and Inspections
  • Small Batches
  • Blood, Blood Products & Plasma
  • Advanced GMP for ATMPs
List of all courses and conferences currently offered and acknowledged in this programme

Your Questions

For questions relative to the ECA Certified Biotech Manager, please contact enquiry@gmp-compliance.org.

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