- 22
- September
- 2023
- Friday
Project Management for Non-Project Managers - Determining the Work that needs to be done
This webinar will walk the participant through the entire process of decomposing a project’s tasks into workable schedulable elements called work packages.
Charles H. Paul |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 22
- September
- 2023
- Friday
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-Hour seminar covers the details of the Regulatory Requirements for a wide range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices, and Combination Products.
Robert J. Russell |
Duration: 3 Hours |
Price: $290.00
| View Details
- 22
- September
- 2023
- Friday
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Mike Thomas |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 25
- September
- 2023
- Monday
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations
This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).
Robert J. Russell |
Duration: 6 Hours |
Price: $545.00
| View Details
- 25
- September
- 2023
- Monday
Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Charles H. Paul |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 25
- September
- 2023
- Monday
4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot
In today’s world, there are a ton of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many companies have reduced their IT staff, so more and more, it is up to each person to deal with all of this data. This seminar will show you how to take large amounts of data from many sources and processes into great reports.
Tom Fragale |
Duration: 4 Hours |
Price: $445.00
| View Details
- 25
- September
- 2023
- Monday
Making your Excel Spreadsheet much Easier to use with Tables
Tables are a powerful Excel functionality to streamline many data management functions.
Ray Evans |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 25
- September
- 2023
- Monday
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
This webinar will help you understand the critical ingredients for conducting an effective root-cause analysis.
Susanne Manz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 26
- September
- 2023
- Tuesday
Excel - Formulas and Functions 101
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Mike Thomas |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 26
- September
- 2023
- Tuesday
How to Write SOPs that Avoid Human Error
Human error is known to be the primary cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 27
- September
- 2023
- Wednesday
6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc.)
This seminar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.
Joy McElroy |
Duration: 6 Hours |
Price: $545.00
| View Details
- 27
- September
- 2023
- Wednesday
The Human Error Toolbox: A Practical Approach to Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 27
- September
- 2023
- Wednesday
Excel - Mastering Lookup Functions
"How do I look up a value in list ONE and pick up a related value from list TWO"
Ray Evans |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 28
- September
- 2023
- Thursday
Excel Charts and Graphs
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Dennis Taylor |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 28
- September
- 2023
- Thursday
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to meet FDA and International Quality Standards
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.
Roger Cowan |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 28
- September
- 2023
- Thursday
How to Deal with Bad Results Under GLP
Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.
John C. Fetzer |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 29
- September
- 2023
- Friday
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 29
- September
- 2023
- Friday
Preventing Human Error in the Life Sciences
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Charles H. Paul |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 2
- October
- 2023
- Monday
Excel - Mastering Lookup Functions
"How do I look up a value in list ONE and pick up a related value from list TWO"
Mike Thomas |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 3
- October
- 2023
- Tuesday
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.
David Nettleton |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 3
- October
- 2023
- Tuesday
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
John E Lincoln |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 4
- October
- 2023
- Wednesday
How to Prepare for and host an FDA Inspection and respond to 483's
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 4
- October
- 2023
- Wednesday
Excel PowerPivot and Power Query
If you work with data, you're likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources.
Tom Fragale |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 5
- October
- 2023
- Thursday
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Dennis Taylor |
Duration: 2 Hours |
Price: $190.00
| View Details
- 5
- October
- 2023
- Thursday
The Transfer of Validated Methods
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods.
John C. Fetzer |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 5
- October
- 2023
- Thursday
How to Write SOPs that Avoid Human Error
Human error is known to be the primary cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 6
- October
- 2023
- Friday
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan.
Robert J. Russell |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 6
- October
- 2023
- Friday
2-Hour Virtual Seminar on Reduce Performance Failures in Your Operations by Addressing Human Performance, Human Error, and Cognitive Effort
In today's fast-paced operational environments, organizations face challenges related to human performance, human error, and mental load. This comprehensive two-hour training program aims to equip participants with the knowledge, skills, and strategies to reduce performance failures in operations.
Charles H. Paul |
Duration: 2 Hours |
Price: $190.00
| View Details
- 6
- October
- 2023
- Friday
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
Advancements in technology have forced organizations to rethink business models.
Carolyn Troiano |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 6
- October
- 2023
- Friday
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training, and experience to complete their job functions.
Michael Esposito |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 6
- October
- 2023
- Friday
Mastering Excel Pivot Tables & Pivot Charts: Number Crunching Made Easy
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Tom Fragale |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 9
- October
- 2023
- Monday
Excel - Quick Tips to Help You be More Productive
Few people learn or use Excel for fun. In fact, many people see it as a necessary evil. So if you have to use it, why not learn to use it faster and more effectively? How often have you found yourself in Excel thinking, "there must be a better and faster way to do this?"
Mike Thomas |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 9
- October
- 2023
- Monday
Secrets to Writing Effective SOPs for Medical Device QMS
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Susanne Manz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 10
- October
- 2023
- Tuesday
Death By CAPA - Does your CAPA Program Need a CAPA?
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process.
Susanne Manz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 11
- October
- 2023
- Wednesday
Excel Formulas and Functions
Excel has over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Dennis Taylor |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 11
- October
- 2023
- Wednesday
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
John C. Fetzer |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 11
- October
- 2023
- Wednesday
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 12
- October
- 2023
- Thursday
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 12
- October
- 2023
- Thursday
Excel Pivot Tables, Pivot Charts, Slicers, and Timelines
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts. We will start with the basics and built up to more complex pivot tables.
Tom Fragale |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 12
- October
- 2023
- Thursday
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.
Carolyn Troiano |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 13
- October
- 2023
- Friday
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Robert J. Russell |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 13
- October
- 2023
- Friday
How To Comply With FDA And European Regulatory Guidelines For Contract Manufacturing Operations - The CMO Supplier Agreement
The webinar begins with an introduction to the regulatory landscape governing contract manufacturing operations. The presenter, an industry expert with extensive knowledge of FDA and European regulatory guidelines, sets the stage by highlighting the importance of compliance and its impact on product quality, patient safety, and market access.
Charles H. Paul |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 13
- October
- 2023
- Friday
Good Manufacturing Practices (GMP) - An Introduction
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
Michael Esposito |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 16
- October
- 2023
- Monday
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions
An Excel formula is an equation or calculation that is stored in a worksheet cell. A formula enables you to perform simple or complex calculations on numbers. So think of any scenario that involves addition, subtraction, division, or multiplication and that's where you'd use a formula.
Mike Thomas |
Duration: 3 Hours |
Price: $290.00
| View Details
- 17
- October
- 2023
- Tuesday
Medical Device Software Validation Meeting FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 17
- October
- 2023
- Tuesday
Essentials of Validation - IQ OQ PQ
Validation is an important element of the Quality System Regulations and ISO13485.
Susanne Manz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 18
- October
- 2023
- Wednesday
The Most Common Problems in FDA Software Validation & Verification
This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations.
John E Lincoln |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 18
- October
- 2023
- Wednesday
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
John C. Fetzer |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 18
- October
- 2023
- Wednesday
2-Hour Virtual Seminar on Responding to FDA 483, Warning Letter, and Consent Decree Findings
This two-hour session is designed to equip professionals in the pharmaceutical, biotechnology, and medical device industries with the knowledge and strategies necessary to effectively address regulatory findings from the Food and Drug Administration (FDA).
Charles H. Paul |
Duration: 2 Hours |
Price: $190.00
| View Details
- 18
- October
- 2023
- Wednesday
The Human Error Toolbox: A Practical Approach to Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 18
- October
- 2023
- Wednesday
3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
Carolyn Troiano |
Duration: 3 Hours |
Price: $290.00
| View Details
- 19
- October
- 2023
- Thursday
Mastering Excel Pivot Tables
Excel has a variety of tools like sorting, filtering, and subtotal to manage large lists of data, but if you need to analyze all that data and do it quickly, there's no better feature than a PivotTable. You can quickly create a compact summary report (based on tons of data) without needing to write complex formulas or rely on lengthy techniques.
Dennis Taylor |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 20
- October
- 2023
- Friday
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Robert J. Russell |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 20
- October
- 2023
- Friday
3-Hour Virtual Seminar on Lean And The Manufacturing Process
Lean manufacturing has gained significant importance in the life sciences industry as organizations seek to optimize their manufacturing processes, improve efficiency, and ensure regulatory compliance.
Charles H. Paul |
Duration: 3 Hours |
Price: $290.00
| View Details
- 20
- October
- 2023
- Friday
3-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Michael Esposito |
Duration: 3 Hours |
Price: $290.00
| View Details
- 20
- October
- 2023
- Friday
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis.
Susanne Manz |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 23
- October
- 2023
- Monday
Excel Basics - Data Visualization - Creating Effective Charts
"Every Picture Tells a Story" is a popular saying which is true not only in everyday life but in Excel too. Behind every set of numerical data is a story waiting to be told. The telling of this story needs to be succinct, easy to understand, and engaging.
Mike Thomas |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 24
- October
- 2023
- Tuesday
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to the FDA.
Carolyn Troiano |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 25
- October
- 2023
- Wednesday
Excel Data Management Tools
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently.
Dennis Taylor |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 25
- October
- 2023
- Wednesday
How to Deal with Bad Results Under GLP
Assessment of the cause for a non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.
John C. Fetzer |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 25
- October
- 2023
- Wednesday
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 26
- October
- 2023
- Thursday
How to Write SOPs for Human Error Reduction
Human error is known to be the primary cause of quality and production losses in many industries.
Ginette Collazo |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 27
- October
- 2023
- Friday
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-Hour seminar covers the details of the Regulatory Requirements for a wide range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices, and Combination Products.
Robert J. Russell |
Duration: 3 Hours |
Price: $290.00
| View Details
- 27
- October
- 2023
- Friday
Excel - Formulas and Functions 101
Although it is perfectly possible to use Excel without ever creating a formula or using a function if you don't, you're missing out on a huge part of the application’s power.
Mike Thomas |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 30
- October
- 2023
- Monday
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments, and to-dos.
Mike Thomas |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 31
- October
- 2023
- Tuesday
Excel Charts and Graphs
This live webinar will show you quick ways to create charts, explore which chart types work best for different data, and give you tips on when and how to add gridlines, change background colors, adjust scaling, insert titles, re-configure 3-D charts, insert clip art images and add trend lines. You can add both functionality and eye-appeal to your charts with simple formatting techniques.
Dennis Taylor |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 31
- October
- 2023
- Tuesday
Business Continuity Planning For Contract Manufacturers In The Life Sciences
Business continuity planning is crucial for contract manufacturers operating in the life sciences industry
Charles H. Paul |
Duration: 90 Minutes |
Price: $150.00
| View Details
- 31
- October
- 2023
- Tuesday
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidances.
Edwin Waldbusser |
Duration: 60 Minutes |
Price: $150.00
| View Details
- 1
- November
- 2023
- Wednesday
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and a live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP-compliant spreadsheet application.
David Nettleton |
Duration: 75 Minutes |
Price: $150.00
| View Details
- 5
- December
- 2023
- Tuesday
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification
This 2-Hour Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls.
David Nettleton |
Duration: 2 Hours |
Price: $190.00
| View Details
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