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Enabling the leaders of the future

pharmaphorum

From clear communication with an unsettled, dispersed workforce to maintaining positive energy and managing people’s working hours, the need for open, inclusive and empathetic leadership has never been more important. . iii] It’s no longer just about the company, compensation package and secondary benefits (e.g., gym membership).

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eMDR System Enhancements

The FDA Law Blog

Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format. For any major changes, additional time will be granted between the release of the implementation package and production deployment.

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Methodology to Define a Pharma 4.0™ Roadmap

ISPE

defines a service-oriented architecture (SOA) where application components provide services to the other components through a communication protocol over a network. The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. April 2015. to Industry 4.0

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Pharmacy practice in emergency care: patient safeguarding

Hospital Pharmacy Europe

Current state of play in ED pharmacy practice Fast-forward to 2015 and, due to shortages of physicians and nurse practitioners, NHS England commissioned the Pharmacists in Emergency Departments (PIED) study. Safeguarding training and knowledge gaps Training in the safeguarding process and the type of maltreatment increases victim recognition.

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DSCSA Postponement And What It Means For Independent Pharmacies

DiversifyRx

Most of the existing requirements have been in place since 2015 and require Pharmacies to have SOPs, Training, and data storage (or agreements with their ATPs in place) to maintain the required transaction data. The four requirements below are handled in various ways.

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Air Speed Qualification: At Working Position or Working Level?

ISPE

Regulatory Background and Cleanroom Air Velocity In 2015, the authors of the Concept Paper on Revision of Annex 1 decided to harmonize the regulatory framework globally, including established methodologies such as those from the International Organization for Standardization (ISO). Published 2 February 2015.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). October 2015. 7 An integrative (vs.