Webinar: Managing Quality – from Deviation and CAPA to Variation and XEVPRM
Sponsored by: Infotehna
Focused on:
Date: 9th May
Days old: 4655
Time: 3PM London / 4PM Paris / 10AM New York
Integral Electronic Document Management System as competitive advantage
In the present tendency to switch every business process to electronic format, it is often overlooked that electronic isn’t always better. Very frequently you can hear mourning about good old paper times, when everything was easy. The most common reason for this sentiment is document and process management system which is not integrated. There is often one application for saving documents, other for tracking, third for reporting, and there may be other dedicated applications – for CAPA, change management, eCTD, and now for XEVPRM. The result is that although e-solutions are in place, everyday work is more complicated than before, and working day passes in logging in and out of different applications, searching for data and composing reports.
The only way how to avoid such mess is to plan in advance and integrate all of your data and process management in one system. This can be accomplished by integration of different applications, but in this case every upgrade of any application requires additional integration and validation, which is both time and money consuming. The other way is to look for application which integrates all of those functions by design.
In this webinar INFOTEHNA myPharmaExpert™ Suite will be presented, and advantages of integration by design will be demonstrated. By using myPharmaExpertTM, your document and process management needs, as well as information tracking and reporting can be addressed without switch between applications – everything is just a click away.
Presented by
Mihajlo Ceraj Ceric, MSc. Pharm.,
Former Director, Pliva (Teva Group member)
Mihajlo Ceraj Ceric is founder and CEO of MCC Consulting, specialized advisory agency for pharmaceutical companies. Prior to his successful private venture, he was 3 decades associated with PLIVA (Teva Group member) where he held a number of managerial posts. Serving on such diverse positions as R&D director, Head of pharmaceutical investments, RA director and Deputy to QA/QC director enabled him to achieve comprehensive and in-depth understanding of business critical processes in pharmaceutical company. After leaving Pliva (Teva Group member) he spent 10 years in INFOTEHNA Group as Life science Director.
Mr. Ceric has particular interest in enterprise content management, and is one of the industry’s top experts in document and processes management. As a consultant he specializes in business process analysis, pharmaceutical procedures streamlining and optimization of electronic document management systems.
Mr. Ceric is also a very prolific author, who has written numerous articles on enterprise content management issues in modern pharmaceutical organizations, and is regular presenter or chair at pharma conferences.
Sinisa Belina, MSc. Pharm. ,
Product development, Process improvement
Mr. Belina started his professional career in PLIVA (TEVA Group member), renowned for its highly competent employees, innovative technologies and continuous investments in production. In addition to his responsibilities in manufacturing, he was part of the very successful Electronic Document Management System (EDMS) implementation project.
In 2007 he joined KRKA, one of the largest generic pharmaceutical companies worldwide, where he worked in Regulatory Affairs department. With years of experience in pharmaceutical business, Sinisa moved to INFOTEHNA as a Life sciences consultant and then he was promoted to Business Services Assistant Director. He applies his detailed knowledge of pharmaceutical documentation and processes principally to areas of business process analysis and optimization of electronic document management systems.
In 2007 he joined KRKA, one of the largest generic pharmaceutical companies worldwide, where he worked in Regulatory Affairs department. With years of experience in pharmaceutical business, Sinisa moved to INFOTEHNA as a Life sciences consultant and then he was promoted to Business Services Assistant Director. He applies his detailed knowledge of pharmaceutical documentation and processes principally to areas of business process analysis and optimization of electronic document management systems.
Download Slides
Please login to download the slidesKey Learning Objectives
- What is the advantage of a solution integral by design
- How processes can be integrated across department boundaries
- What can workflows with integrated reminders do to streamline your process
- How you can get all the reports you need, without once transcribing the data
Audience
- Senior Executives
- Departmental Heads
- Directors
- Heads of Regulatory Affairs
- Research and Development
- Quality Assurance
- Quality Control