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.
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...
ISPE hosted more than 450 attendees in person and virtually for the 2024 ISPE Aseptic Conference in Vienna, Austria. Keynotes and education sessions provided a comprehensive overview of key topics and trends...
