Regulatory Challenges of Real-world Artificial Intelligence (AI) and Machine Learning (ML)
This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Regulatory Challenges of Real-world Artificial Intelligence (AI) and Machine Learning (ML)
This session will provide insights on moving from the traditional regulatory strategies for mature technologies to the new regulatory strategies for novel uses of AI and ML while engaging FDA and/or Notified Bodies in the effort. The IMDRF, US and EU perspectives on what's next for AI and ML as SaMD will be explored.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA's Cloud Compliance & Regulations
This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science".
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities,which in turn generate many types of electronic records.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Make Your FDA Inspection as Painless as Possible
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA's Cloud Compliance & Regulations
This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will learn the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
European Data Protection Regulation - 2018 Implementation
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Writing Effective SOPs
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Excel Spreadsheets for 21 CFR 11 Compliance
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3 Hours Virtual Seminar on Boot Camp: Data Integrity - FDA's Latest Thinking
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
FDA's Enforcement of 21 CFR Part 11 Compliance
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
European Data Protection Regulation - 2018 Implementation
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
Speaker: Angela Bazigos | View Anytime | Duration: 2 Hours | Price: ¤190.00 | View Details
FDA's Enforcement of 21 CFR Part 11 Compliance
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-hour Virtual Seminar on Analytical Method Validation Process
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.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest
Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
European Data Protection Regulation - 2018 Implementation
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA's Enforcement of 21 CFR Part 11 Compliance
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-hour Virtual Seminar on Analytical Method Validation Process
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.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
Speaker: Angela Bazigos | View Anytime | Duration: 2 Hours | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Project Management for 21 CFR 11
This class will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA Enforcement of 21 CFR 11 Compliance
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 data integrity, security and availability of electronic records but also related to validation of software and computer systems. However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what the FDA is looking for in these inspections.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
21 CFR 11 Compliance for Excel Spreadsheets
In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. 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.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA Enforcement of 21 CFR 11 Compliance
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 data integrity, security and availability of electronic records but also related to validation of software and computer systems. However, typically, citations are against the predicate rules, not part 11 itself. This is very confusing and makes it difficult to determine what the FDA is looking for in these inspections.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
Speaker: Angela Bazigos | View Anytime | Price: ¤190.00 | View Details
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
Speaker: Angela Bazigos | View Anytime | Duration: 2 Hours | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Speaker: Angela Bazigos | View Anytime | Price: ¤190.00 | View Details
Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Price: ¤190.00 | View Details
FDA's enforcement of 21 CFR part 11 compliance
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤167.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤163.00 | View Details
Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤157.00 | View Details