Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
When QUALITY meets OPEX in manufacturing
PHARMA and Biotech leaders understand the importance of shifting from a culture of compliance to a culture of quality.
Times of transformation call for increasing overall quality and efficiency while lowering costs in order to follow regulations and maintain a competitive edge.
Can you sustain the leadership commitment and employee engagement required in the continuous improvement of quality? Do you know how to overcome resistance to change and successfully lead engaged employees who see the importance of the overall strategy?
On 22 – 23 September 2016, Vienna will be the place where Quality meets OPEX. Organized by Fleming., delegates will have the unique opportunity to attend two events in one and meet 100+ industry professionals under one roof.
At the 12th Annual Quality in Pharma & Biotech Forum, participants will discuss with leading experts how to translate a quality culture into operations and close the loop on their desired level of quality. They will gain insight into GMP inspection trends, data integrity requirements, quality metrics, Lean Six Sigma approach in a quality unit, CMO quality oversight, quality risk management in issue handling, serialization and technology transfer strategies.
The 12th Annual OPEX in Pharma & Biotech Forum will provide insights into developing defect-free processes. Attendees will find out how to achieve manufacturing excellence through more competitive improvement strategies in Digitalization, Six Sigma and advanced technologies such as 3D printing. Experts will explain how to lead initiatives even further, develop operating models in an autonomous work environment and create strong learning loops to adjust the operational excellence approach.
One day prior to the event, on 21 September, a pre-conference site visit to the facilities of Baxalta, one of the largest biopharma companies in Austria, will be prepared for interested participants.
Interested in this topic?
Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
Attendees will be introduced to comparability in biosimilar development, the analytical strategies of protein characterization of biosimilars, the structure of proteins, in vitro pharmacology and much more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Driving the national agenda of Medical tourism through PX Excellence
Read the interview with Dr. Layla Al-Marzouqi, Director of Medical Tourism Council at Dubai Health Authority, and learn how to enrich patient experience and quality of healthcare.
No more trouble with dangerous good shipments
Global temperature controlled pharmaceutical shipments are constantly faced with new logistics challenges and regulations. This January 2017, IATA Dangerous Goods Regulations added further complexity to shipping cold chain products compliantly.
5 Changes in Signal Detection Management
The European Medicines Agency, regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals. A safety signal is generally defined as information about a new or known Adverse Event that may have been caused by a medicine, where it is therefore necessary to conduct further investigation. Evaluation of safety signals plays a major role within pharmacovigilance. Therefore, it is vital for regulatory authorities to know the latest updates detailing the risks and benefits of medicines. The EudraVigilance database is an important source of information on suspected adverse reactions and signals.