Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.
Artesan Pharma Gmbh & Co. KG in Lüchow, Germany, demonstrates how an effective program of serialization, i.e. the traceability of medicines, can successfully be put into practice in today's pharmaceutical industry.
If you were to take a look at the criminal statistics of any given country, you would soon gather that counterfeits, imitations and fake products are on the rise among international criminal offences. Virtually all sectors have been affected; whether the electronics industry, the pharmaceutical industry, the automotive industry or the capital goods industry. It is an alarming development that has led governments and international organizations to draw up laws and measures against this growing crime.
Which parameters must pharmaceutical manufacturers take into account for scale-up? How can Quality by Design be introduced in the development phase?
This webinar discusses how achieving accurate demand forecasts is extremely challenging, especially for new drug launches, and what other pharmaceutical companies are doing to overcome those challenges.
In this webinar we will share best practices that demonstrate how to connect directly to data sources in the production lines, record and then store the data in secure databases.
Join Vaisala Regulatory Expert Piritta Maunu as she discusses methods of stability testing in drug production and how they relate to monitoring.
Why and how Multivariate analysis and Design of Experiments can make the difference in process automation and quality improvements cases.