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.
ECA Certified
Biotech Manager
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
List of all courses and conferences currently offered and acknowledged in this programme
(including detailed information on every event – venue, dates, fees and agenda as PDF)
(including detailed information on every event – venue, dates, fees and agenda as PDF)
Your Questions
For questions relative to the ECA Certified Biotech Manager, please contact enquiry@gmp-compliance.org.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others