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THE PHARMAPACK EXHIBITION brings together more than 250 companiesrepresenting the leading designers, manufacturers and suppliers of drug packaging and delivery systems. It also attracts the highest decision-makers of pharmaceutical, biopharmaceutical, veterinary laboratories, institutions and health companies

This 3-hr virtual seminar on HIPAA Privacy and Security Audits and Enforcement will cover HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited. Documentation requirements, enforcement actions and how to prepare and respond to an audit will also be explored.

Why Should You Attend:

This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.

Why Should You Attend:

Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming,in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR?