A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
This program is going to be presented to give the attendees a better or broader perspective of how to use this program from a more comprehensive understanding based upon how this system has been proven to be very successful in gaining FDA approval when the field inspectors have come in to do their job to ensure this facility is operating in a way that is very reliable and consistent in dong what is needed to minimize patient risk.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained.
Speaker: Jerry Dalfors | View Anytime | Price: ¤190.00 | View Details
Make sure our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP) as well as vendors supplying product specific raw materials unique to this product.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: ¤158.00 | View Details
Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details
Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and the overall process results based on statistical database for each batch of that product code. Strategies for process control and operator activities can be designed to reduce variation, adjust for variation during manufacturing and reduced possibility for operator error, as well as an overall blend to manage critical process parameters (CPPs) as well as the original process limits which typically change after the initial validation as well as the trend analysis for each critical step of the process.
Speaker: Jerry Dalfors | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details