Are You Considering Annex 1
Sterile Manufacturing Requirements?
Lachman Executive Director Keith A. Lamb, Ph.D., and Principal Consultant in the Compliance Practice, Patrick Day, M.S., along with Senior Directors, Paul L. Dexter, M.S., and Adnan Ziaullah recently hosted a seminar entitled, “Are You Considering Annex 1 Sterile Manufacturing Requirements?” The distinguished participants provided actionable information to evaluate an organization’s status in fulfilling the protocols and assist in the development and implementation of a measurable plan to satisfy the newly expanded Annex 1. The requirements went into effect on August 25, 2023. The webinar also offered critical perspectives, insights, and guidance, focusing on the struggles that many companies face in addressing this complex challenge from different directions and with diverse tactics and strategies.
Among the topics discussed in this webinar are:
- Identifying your weaknesses in accordance with Annex 1
- Preparing and laying out a scope for your risk assessment
- Creating a culture of continuous improvement
- Diagnosing potential risks across your supply chain
ADDITIONAL RESOURCES
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