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:The EU's new Cosmetic Product Regulation (EU CPR) will be given a certain, wider position as the EU CPR is representing the latest, most modern regulatory framework which is influencing other global legislators. Areas Covered in the Session:Basis principles and provisionsExperiences and obstacles from the implementation phaseOptions for compliance approaches and available supporting toolsRemaining issues and future perspectives and ac...

FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are discussed and the implications of both a good and poor response to a possible Warning Letter are given. Why you should attend: Learn how to respond to FDA 483's and the best way to write the response. Learn the new policy from FDA regarding how and when to respond. Learn the best way to respond in...

Overview: We will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits and reagents specifically applicable to microbiology laboratories. Why should you Attend:During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits and reagents specifically applicable to microbiology laboratories. Areas Covered in the Session:Control Point...