Get out of the cold this winter and head down to sunny Florida to take advantage of pharmaceutical industry lead training from ISPE.
Courses in February and March include:
GAMP®* Approach to Data Integrity (T50) New! 6 – 7 February Gain a practical understanding of the current regulatory focus on data integrity and provide tools and solutions.
HVAC (T14) Updated! 8 – 10 February Examine the challenges and accepted HVAC solutions, including control system alarm management; common system construction deficiencies; cGMP documentation; how to maintain an "inspection ready" state; frequency of testing and balancing; airflow visualization and air change rate reduction and a review of ISO14644-1 & 2.
Clean In Place (T03) Updated! 13 – 14 February Submerge yourself into this hands-on workshop for working in groups to design, build, and implement a cleaning process for a pharmaceutical application.
Facility Project Management in the Regulated Pharmaceutical Industry (T26) 6 – 7 March Develop the concept of the project lifecycle from initiation through to delivery of business benefits and get the tools needed to manage all project resources in the highly regulated pharmaceutical industry.
GAMP 5 GxP Compliance (T21) 9 – 10 March Highly interactive course to help you achieve process control systems that are fit for intended use and current regulatory requirements while utilizing the principles and concepts of GAMP 5.
Process Validation in Biotechnology Manufacturing (T32) 27 – 28 March Gain a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses, as well as identifying the long list of activities required to validate biopharmaceutical processes.
Practical Application of Technology Transfer (T19) 30 – 31 March Identify criteria for successful technology transfer (TT) and receive ‘how to’ examples which can be individually tailored, depending on the type and scope of your transfer. Share with a Colleague! Unable to attend? Share this email with a fellow colleague who may be interested in a training course. In return, they can share all their new pharmaceutical knowledge with you.
Don't forget—ISPE also offers online learning and onsite training opportunities.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...