Good Distribution and Storage Practices for Life Science Products

Why Should You Attend:

You should attend this webinar if

(i) you are a compliance and quality auditor.
(ii) you may be called upon to assist one or a team of auditors going into your own company’s or a contracted warehouse or distribution center.
(iii) you may be called upon to perform a department self-inspection.
(iv) you are a member of supply chain or logistics supervision or management who will host future audits and regulatory inspections.

This webinar will show you what to cover in a well-planned and organized distribution center or warehouse audit as well as how to obtain audit evidence. Even if you will never perform or assist an audit in the future, if you are a member of the supply chain or logistics department and especially its management, it is incumbent upon you to learn how an auditor/inspector thinks and thus how you should begin to help your department become more GMP compliant and audit-friendly.

By attending this training you will gain the knowledge necessary to ensure successful preparation for and performance during a regulatory inspection. It is highly important since, often this sets the tone (especially the first impressions) for the larger inspection of all the processes at a life science product manufacturer.

Areas Covered in the Seminar:

• The purpose of a warehouse or distribution center.
• What information might be requested in advance of an audit or regulatory inspection.
• Regulations and guidances applicable to warehouses and distribution centers (some are also pharmacies).
• Personnel and training.
• Environmental control (temp, humidity), alarms, site security, business continuity/disaster recovery.
• Preventive maintenance and calibration.
• Contract service provider qualification.
• Housekeeping and pest control.
• Inventory control, First-Expired-First-Out.
• Expired, damaged, and returned goods.
• Preparations for shipping (Location-dependent).