The PharmaExperte® with APV Diploma Seminar (May 10 - 11, 2023)

The PharmaExperte® with APV Diploma Seminar is organized by Working Group for Pharmaceutical Process Engineering eV / Arbeitsgemeinschaft fur pharmazeutische Verfahrenstechnik e.V. (APV) and will be held from May 10 - 11, 2023 at Oranien, Wiesbaden, Hessen, Germany.

OBJECTIVE:
Participants will gain in-depth insight into:
• Relevant regulations
• Classification options and definitions of standard substances
• Procurement and sources of supply of standard substances (from pharmacopeia standard   to synthesis)
• Requirements, characterization, and qualification of standard substances
• Adjustment of standard substances
• SOPs and documents for the correct handling of standard substances
• Special features of biological molecules "biopharmaceuticals"
• Correct handling and monitoring of standards and reagents (hard copy vs. LIMS incl.   practical demonstrations of LIMS systems)
• responsibilities
• Use periods and shelf lives
• Storage and transport of standard substances (including qualification of storage   locations/storage conditions)
• Compliance with the cold chain for biological molecules "biopharmaceuticals"
• Use and handling of standard substances in the laboratory (what is allowed, what is   not, including practical examples)
• Use of pharmacopoeial standards (USP, EP, etc.)
• Use of biomolecules as a standard substance
• Standard substances in the audit focus (e.g. FDA), typical audit findings, and CAPA   measures

Additional details will be posted as soon as information is available.