The document summarizes key FDA regulations and guidance related to electronic records and electronic signatures, including 21 CFR Part 11. It outlines requirements for electronic signatures from regulations like 21 CFR Part 11, Annex 11, and guidance documents from the FDA and EMA. The document emphasizes that these regulations apply to all electronic records, not just those with electronic signatures, and are intended to help catch criminals by ensuring the integrity of electronic records and signatures.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...ICHAPPS
TRAINING PROGRAMME ON
21CFR PARTS-210 AND 211
QUALITY ASSURANCE
Slideshow About 21 CFR
“Every product must be fit for its intended purpose”
“Every product must be fit for its intended purpose”
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES- UNITED STATES OF AMERICA
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
Complying with 21 CFR Part 11 - Understanding the role of predicate ruleJasmin NUHIC
To obtain knowledge and understanding of 21 CFR Part 11 as how it applies to you as well as be advised of consequences which may result in failing to comply with this regulation.
The presentation describes how to conduct reliability planning and testing for software controlled electron-mechanical systems. It is based on working experience in US FDA, FCC and European CE regulated companies. The presentation provides practical and rational steps to improve product reliability and comply with applicable regulations.
研讨会简报介绍了如何进行软件控制的电子机械系统的可靠性规划和测试。它是基于在美国FDA,FCC和欧洲CE规管公司的工作经验。研讨会演示文稿提供仅结合实际,合理的措施来提高产品的可靠性,并遵守适用的法规.
7 Mistakes of IT Security Compliance - and Steps to Avoid ThemSasha Nunke
This presentation describes seven typical IT security compliance errors and outlines the best practices you can immediately apply to your environment to help your company achieve compliance.
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...ICHAPPS
TRAINING PROGRAMME ON
21CFR PARTS-210 AND 211
QUALITY ASSURANCE
Slideshow About 21 CFR
“Every product must be fit for its intended purpose”
“Every product must be fit for its intended purpose”
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES- UNITED STATES OF AMERICA
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
Complying with 21 CFR Part 11 - Understanding the role of predicate ruleJasmin NUHIC
To obtain knowledge and understanding of 21 CFR Part 11 as how it applies to you as well as be advised of consequences which may result in failing to comply with this regulation.
The presentation describes how to conduct reliability planning and testing for software controlled electron-mechanical systems. It is based on working experience in US FDA, FCC and European CE regulated companies. The presentation provides practical and rational steps to improve product reliability and comply with applicable regulations.
研讨会简报介绍了如何进行软件控制的电子机械系统的可靠性规划和测试。它是基于在美国FDA,FCC和欧洲CE规管公司的工作经验。研讨会演示文稿提供仅结合实际,合理的措施来提高产品的可靠性,并遵守适用的法规.
7 Mistakes of IT Security Compliance - and Steps to Avoid ThemSasha Nunke
This presentation describes seven typical IT security compliance errors and outlines the best practices you can immediately apply to your environment to help your company achieve compliance.
Implementing Agile in an FDA Regulated EnvironmentTechWell
Developing medical devices that are subject to FDA approval has traditionally followed the waterfall methodology, largely due to the structure of the regulations that govern development practices. But we know from myriad case studies in different industries that agile methodologies are far superior in providing the highest value to customers in the shortest time to market. Neal Herman shares how one developer of complex medical devices embraced agile software development practices and proved that it could not only develop software faster with higher quality but also meet all regulatory requirements. Convincing the internal quality management, systems engineering, and regulatory departments was difficult, but the software department was able to overcome these obstacles and fundamentally change the company’s philosophy on product development. Since 2012, software development productivity is up 100 percent, and quality is up 200 percent. Now, after seeing these gains from the software department, agile is being rolled out to all areas of R&D including hardware.
Managing Reliability Expectations & Warranty Costs in Medical ElectronicsCheryl Tulkoff
What are ‘medical’ electronics?
Is it a realistic category?
Some implanted in the body; some outside
Some portable; some fixed
Some complex; some simple
Some control; some monitor; some medicate
All connected by the perception that one’s life
may be dependent upon this product
Creates a powerful emotional attachment/effect
Assuring reliability becomes critical
Leardon Solutions Product Development and Commercialization Lifecycleleardonsolutions
This presentation describes the detailed activities for each phase and checkpoint in Leardon Solutions' Product Development and Commercialization Lifecycle.
This webinar is focused on the current state of UDI regulations, the best approaches to medical device UDI Compliance in the cloud and how to gain business benefits by implementing KPIT's UDI Cloud Solution. This is a must-watch session for medical device companies who are preparing for UDI compliance or the ones who have already implemented however looking for a long-term solution.
5 Things To Consider When Making A Change To An Existing Medical DeviceEMMAIntl
In this constantly changing world, it is important that your products keep up with the latest technology available. With medical devices now being in the form of wearables, long gone are the days when patients needed to be hooked up to a system to monitor their health.
Continuously improving your product requires you to make changes, and some of these changes may require notifying the FDA in the form of supplemental reports, 510(k)s, etc...
In this presentation from, Janeen Santorosa discusses the best practices for harmonization of GMP auditing, domestic and international regulations for supplier auditing, integration of risk-based practices, and supplier audit practice tools.
In this presentation from IVT's 4th Annual Validation Week EU, Paul Pluta, discussed the differences between the traditional approach to cleaning validation and the lifecycle approach, applicable regulatory guidance, current industry trends, the necessary phases of the lifecycle approach (design and definition, cycle development, validation, and implementation), how to continously monitor the process, change control, and common obstacles to compliance.
This session from the Institute of Validation Technology's 14th Annual CSV Conference looks at B. Braun’s journey in moving from an in-house validated training tracking system to learning management in the cloud.
In this session from the Institute of Validation Technology's Validation Week Europe, Kurtis Epp and John Kandl discuss how to implement QbD to all three stages of process validation.
This presentation from the Institute of Validation Technology's first annual Validation and cGMP Compliance Week Singapore discusses the obstacles to quality such, the key components to improve quality, and the tools for strategic teamwork.
This session from the Institute of Validation Technology's Contamination and Control Week discusses regulatory expectations and industry drivers for aseptic cleaning and environmental monitoring, regulatory expectations for cleanrooms, and current FDA and EU expectations during inspection of sterile and aseptic operations.
In this presentation from the Institute of Validation Technology's Life Sciences Aseptic Processing, Kim Van Antwerpen discusses collecting environmental data, methods for trending, and interpreting and sharing environmental monitoring data.
Regulatory inspections have had a significant impact on the number of drug shortages and companies facing adverse regulatory actions.
Review of the inspection trends can be useful in assessing the regulatory status of your own company and help aid in the preparation for upcoming inspections. This session from IVT's Contamination and Control Week provides an in-depth, practical look at some of the recent Warning Letters and discusses current trends.
The Validation Master Plan is a a valuable opportunity to provide an overview of your company’s validation process, including organization structure, content, and planning.
Regulatory guidelines on stability testing are mainly designed to address studies that will be applied to support NDAs. However, in any pharmaceutical development program, a number of other stability studies are also required, for example, to help select appropriate formulations and to support regulatory applications for clinical programs. This session from the Institute of Validation Technology's Stability Programs Forum outlines a number of examples of early development stability studies.
This presentation from IVT's 4th Annual reviews what to do when you have an exception, critical vs. non-critical exceptions, and learning how to prevent exceptions.
This presentation from IVT's 4th Annual Validation Week Europe provided a thorough explanation of developing a gap analysis, areas in validation that are issues of concern, and FDA expectations of a manufacturer's gap analysis.
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
This workshop examines the approach to Continued Process Verification and demonstrating that your product and process are operating in a state of control and continue to do so over the life of the product. Without any prior coordination, the theme was elaborated by the afternoon speakers once the conference itself was underway. The concept of “step up step down” for adjusting the level of product scrutiny both for process parameters monitoring and for sampling and testing quality attributes was explored and developed.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
This presentation from IVT's 2nd Annual Validation Week Canada covers the 2011 FDA Process validation and the subsequent statistical processes. Statistics in process validation is introduced as well as the integration with six sigma and solutions to common mistakes.
A comprehensive presentation on GMP systems and integration. This includes validations, vendor qualification, preventative maintenance, audits, CAPA, and utilization of system results.