Thursday July 25, 2019
12:00 pm – 1:30 pm EDT
Instructor: Nissan Cohen
Annex 1 is a European guidance document for Sterile Medicinal Products. Annex 1 was originally devised in the early 2000s and is currently under revision. The topics and subjects of Annex 1 are extensive defining all aspects of Sterile Medical products processing, manufacture, and critical utilities used. These subjects include barrier technology, cleanroom classifications and qualification, water systems, disinfection, steam for sterilization, compressed gases, cooling systems, terminally sterilized products, aseptic preparation, different aspects of sterilization, closed and single use systems.
This seminar will provide a comprehensive overview of Annex 1 with discussion on the role of guidances versus pharmacopoeial mandates. Bioparmaceutical companies marketing products to Europe need to be cognizant of Annex 1 as this guidance, in its current form, is enforced by European regulatory authorities. The current draft revision is expected to be published in early to mid-2020.
Who should attend:
- Sterile product processing personnel
- Aseptic manufacturing personnel and management
- Critical Utilities personnel supplying water, gases, and HVAC supporting aseptic manufacturing
- Engineering and maintenance personnel
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-122