The Sales & Marketing Effectiveness in Chemicals Forum will bring together industry leaders as well as experts responsible and deeply involved in sales and marketing strategies.
Topic insight: Quality Culture: GxP?, GMP?, or just Good Managerial Practice?
Harvey and Green (1993) outlined the nature of quality culture, which was seen, at the time, as a functuon of manufacturing industry:
A culture of quality is one in which everybody in the organisation, not just the quality controllers, is responsible for quality. A central feature of such organisations is that each worker or team of workers is both a customer of, and supplier to, other workers in the organisation: they form a chain of internal customers and suppliers. It is the responsibility of each unit to ensure the quality of their own work. The emphasis is on ensuring that things are ‘done right first time’. When they are not then the process that has led to an unsatisfactory output is analysed so that corrections can be made in the process to ensure that the problem does not arise again. In a quality culture there is no need to check final output. Indeed to do so, is to shift responsibility away from those involved at each stage.
Over the last 20-odd years working in 'controlling functions' in the pharmaceutical and allied industries we have heard variously about:
- GMPs for the 21st Century
- the 'cost of quality'
- the 'cost of compliance'
- Quality By Design
- Design for Validation
- Right First Time
- Governance and policy
- Data-driven decision making
plus a whole host of other buzzwords. But at the end of the day the attitude towards Quality, Ethics and Compliance is based on the MINDSET of the company and it's employees.
The commitment and understanding of Senior Leadership, Middle Management, Team Management and the individual is critical. If any of these groups mess up, you can forget all about 'GxP'. In essence, GxP relates to some very simple questions:
- 'How well managed is the company?'
- 'Does the company plan to succeed or fail?'
- 'How does the company deal with and learn from its mistakes?'
- Is the company driven by its shareholders, the senior leadership team, the good of the patient or simply the dollar bill?
More recently, in 2014 in the Harvard Business Review, Srinivasan & Kurey concluded the following:
A company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one
The purpose of this presentation is to consider and identify the way companies are managed and how this impacts the consistent provision of effective, efficacious and good value products. After all, who picks up the cost when it all goes wrong?
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.
Hassle-free air shipments with data loggers – 100% IATA compliant
Shipping temperature controlled pharmaceuticals is a complex business, with many variables and multiple supply chain partners involved. When shipments are sent with data loggers, they are subject to specific IATA and Dangerous Good Regulations to increase security of air cargo shipments. These regulations have become stricter year on year and reached a new level in 2017.
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.
Hazardous chemical waste and its impact on the environment
Discover more about production and threats that are caused by hazardous chemical waste.