Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
cGMPs in the Quality Control Laboratory
Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details
Analytical Method Validation
An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
Speaker: Jerry Lanese | View Anytime | Duration: 90 Minutes | Price: ¤189.00 | View Details