Overview: The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Why should you Attend: FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Areas Covered in the Session:E...

Overview: The trends will impact virtually every industry that is dependent on supply chains. There is a convergence of supply chain trends that will dramatically change the global marketplace. Why should you Attend:Understanding of the supply chain trends that will dramatically impact business over the 2-5 yearsWhy purchasing decisions must consider transparency and sustainability Why the triple bottom line is becoming increasingly important...

Overview:This webinar explains the basics, by using a t-test as an example. One of the very many possible formulas is then demonstrated, as well as 2 different software programs and their "Power Curves". Why should you Attend:Whenever a test of statistical significance is conducted with the hope that the result will be non-significant, the results may be unacceptable to a regulatory agency unless the test had an acceptable level of "power". Ar...

Overview: Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods. Why should you Attend: Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances a...

Overview: It is just a fact of life that someone on your team, whether you selected them or whether they were assigned to you will be a non-performer. Why should you Attend:Are you spending too much of your own time trying to recover for the poor performance of team members? Are you missing deadlines because others can't get their work to you on time? Areas Covered in the Session:How to identify potential performance issuesHow to evaluate team...

Overview: This webinar will cover fundamental extrusion processing hardware as well as how that hardware is operated in order to produce the desired product. Both single and twin screw extruders and their differences in operating characteristics will be covered. Why should you Attend: Extrusion processing is a complex process and is regarded as a science with a healthy dose of art, typically requiring many years of practice to master. Areas Co...

Overview:The course will be delivered in two modules. The first module will cover federal and state regulatory agencies governing compounding pharmacies and handling of hazardous drugs for sterile and nonsterile compounding according to USP 800. Why should you Attend: After the debacle of New England Compounding Center meningitis outbreak, the field of compounding pharmacy came into extensive scrutiny by federal and state regulatory agencies....

Overview:How to include critical reagents comparison, selectivity experiments, assessment of stability, importance of communication between the development and the validation labs and accuracy of transfer documents. Why should you Attend:Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees validity of results. If you work in pharmaceutical...

Overview:In this interactive session author will discuss about the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule. Why should you Attend:The benefits require the correct information for FDA and U.S. Customs software programs. At least now, using the PREDICT and ACE programs let you check the status of your entry and what the communications are between your broker and U.S. Cu...

Overview:This webinar will take you through the discussion of how environmental monitoring data is reviewed for product release, also this session provides meaningful information on the quality of the aseptic processing environment. Why should you Attend:This webinar first explains the various US and international regulatory requirements for the various clean room classifications as well as the environmental monitoring of clean room environmen...