The long-awaited draft of the revised Annex 1 was released for discussion last year and now the final revision is anticipated later this year. The document’s focus and content has changed significantly, and the industry is eager to see how these changes will result in new requirements, inspection expectations, and overall process control strategies. Clarification on the intent of new and existing requirements is anticipated. This conference will cover the impact on the industry and on manufactures. Local authorities and industry speakers representing medicines and vaccines manufacturers, as well as equipment and instrumentation suppliers, will present their views on the revised Annex 1 and the modifications it induces. Sufficient time has been allocated to discuss how to address the new requirements and be proactive in getting ready to comply with the new regulation.
The long-awaited draft of the revised Annex 1 was released for discussion last year and now the final revision is anticipated later this year. The document’s focus and content has changed significant ...
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