Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: ¤240.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: ¤240.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH
The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding and Implementing USP 1058 Analytical Instrument Qualification
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This webinar will provide a good understanding on how to effectively conduct and document method validation, method re-validation and periodic review.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
New FDA, EMA and USP Guidelines for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This Webinar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This webinar will provide a good understanding on how to effectively conduct and document method validation, method re-validation and periodic review.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding and Implementing USP 1058 Analytical Instrument Qualification
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding and Implementing USP 1058 Analytical Instrument Qualification
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the New USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
New FDA or EMA and USP Guidelines for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This Webinar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Control of Excel Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g for data capture, data evaluation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to control, validate and use Excel® requirements can be met. Attendees of this webinar will get all details on how requirements can be met.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding and Implementing USP 1058 Analytical Instrument Qualification
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation of Analytical Methods and Procedures
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data.
Speaker: Dr. Ludwig Huber | View Anytime | Price: ¤190.00 | View Details
Effective Training Practices for FDA Compliance
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. In the meantime the USP has published an updated general chapter <1224>.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program. Just in the last three years, FDA issued more than 30 warning letters with Part 11 and data integrity violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Good Laboratory Practice Regulations - Introduction and Strategies for Implementation
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding and Preparing for FDA's on-going Part 11 Inspections
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last four years FDA has issued more than 30 warning letters with Part 11 deviations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Implementing the New FDA Data Integrity Guide
In the last couple of years FDA has increasingly observed CGMP violations involving data integrity lapses during CGMP inspections. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. For better understanding FDA's data integrity expectations the agency has published a draft guidance answering 18 questions related to data integrity for cGMP compliance.
Speaker: Dr. Ludwig Huber | View Anytime | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding and Preparing for FDA's on-going Part 11 Inspection Program
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 24 months FDA issued more than 30 warning letters with citations Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Good Laboratory Practice Regulations - Introduction and Strategies for Implementation
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations. Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Effective Training Practices for FDA Compliance
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
FDA's New Enforcement of 21 CFR Part 11
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Analytical Instrument Qualification According The New Revision of USP 1058
The first version of USP <1058> has been released in 2008. Since then it has evolved as the global standard for analytical instrument qualification, despite of some deficiencies of the first version.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
Calibration and Qualification in Analytical Laboratories
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤183.00 | View Details
Auditing Computer Systems for FDA and International Compliance
Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤178.00 | View Details
Quality by Design (QbD) for Development and Validation of Analytical Methods
Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: ¤189.00 | View Details
FDA Compliant HPLC Qualification and Performance Testing
High Performance Liquid Chromatography is the most frequently used analytical tool for pharmaceutical and API testing laboratories. FDA and international agencies require HPLC equipment to be calibrated, qualified and tested to ensure accurate and reliable analytical results. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis.
Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: ¤189.00 | View Details