21 CFR PART 11: Complete Manual for Compliance Success

FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities.
21 CFR PART 11 Complete Manual for Compliance Success

The number of warning letters is increasing proportionally and we as quality and other professionals utilizing the technology and systems to support our businesses are not ready – we are not ready to prepare and host FDA inspections when Part 11 is in scope, we are unsure how to best use and implement Audit Trails and certainly we have challenges with internal and external auditing for Part 11 compliance. This webinar address all these topics and provides you with plenty HOW TO we as auditors and inspectors increase our comfort level with the regulation, with its elements and compliance and practically implement audit system and audit trails – especially since Audit Trails play major role in Part 11 compliance – they can be your best friends and/or worst enemies at the same time.

Areas Covered in the Seminar:

  • How to Prepare and Host FDA Inspections (will cover elements and details of preparation for the inspection as well as elements of the successful practices of hosting an FDA inspection when Part 11 is in scope or the scope of the inspection. We will also cover some commonly asked questions by the inspectors and benefits of being compliant)
  • Internal and External Auditing for Part 11 Compliance (this subtopic includes all aspects of auditing for Part 11 compliance- starting at the audit program level and then going down on how to prepare for an audit to how to successfully execute the audit and follow up on the completed audit. This subtopic also includes CAPA and responses for the audit findings related to Part 11 – what to expect and handle the difference between “regular” audits and Part 11 audits. We include some of the common audit findings and common pitfalls as well as tools for a successful planning and execution of the audit.)
  • Audit Trails (includes types of audit trails, strategies for implementing complaint audit trails, proms and cons of audit trails, how to use audit trails as an audit tool during the internal and external audit as well as during the FDA inspection visit, some examples of “should” and “shouldn’t” when it comes to the audit trails and commonly asked questions related to audit trails.)
  • Overview and Understanding of the Regulation (covers topics such as introduction and development of the regulation, what to expect in the future when it comes to the regulation, options for (non)compliance, “what ifs”, as well as most impactful sections and subsections of the regulations.)
  • How Part 11 Regulation Relates to Other Regulations (this subtopic compares the Part 11 regulation with other regulations focusing on commonalities so that you and your organization can see how easy/hard is to identify gaps as well as how harvest the low hanging fruits when striving to comply with Part 11 regulation. We cover comparison with 3-4 other regulations quoting the exact subsections of each.)
  • Sample Audit Questions (throughout the material, we ensure that we present you and prepare you to deal with some commonly asked audit and inspection questions. These questions are ready-made for you to use when you and your team are conducting internal and/or external audits, but they are also ready-made for you and your team to use as you prepare to/and host FDA inspection when Part 11 in scope of the inspection. We include some of the questions in the material presentation and in addition to that we provide you with additional 30+ commonly asked questions document which you can use for your references and training purposes.)
  • Trends; Warning Letter Examples; Advantages and Challenges of the Regulation (we conducted research to bring you and your team results of inspections and audits that have been conducted in past several years. We include trends and graphs showing how and where Part 11 regulations impacts you the most, but will also show examples of the warning letters that have been issued in last several years due to lack of compliance with the Part 11 regulation. Finally, we cover and include some examples of advantages and challenges you may be benefiting from or facing to address while striving to be Part 11 compliant.)
  • More (we talk about the importance and significance of the regulation regardless if it (currently) applies to you or not. We provide examples and HOW TO so that you and your team can get most out of the materials and presentation – and to be able to use it immediately after attending this training/webinar.)

Who Will Benefit:

  • Quality Managers
  • Quality Engineers
  • Manufacturing engineers
  • CAPA investigators
  • Inspectors
  • Six Sigma specialists
  • Consultants
Speaker Profile

Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation.

Software vendor qualification

Since many of the present generation’s medical devices are run by software; a practical approach is to have this software validated. This validation, also known as software vendor qualification, is a means to ensuring that the software, the heart of the medical device, is compliant with set standards. The principles of this qualification are set out in 21 CFR Part 11.

Why is software vendor qualification needed?

It is generally more economical for medical device companies to buy commercial off-the-shelf software (COTS) than having it developed in-house. Software vendor qualification is the means to ensuring this. This is not only cost-saving; it also saves manpower resources and the time taken to bring the product out into the market. When companies install software that is not built in-house; they need to have COTS that meets some regulatory requirements.

COTS could include software packages like display managers, peripheral interfaces, communications protocols or operating systems. The medical device company needs to have processes that evaluate software packages for their ability to meet intended needs. The companies also need to have processes for software vendor qualification, which will help their products meet strict regulatory requirements.

When should software vendor qualification be done?

An important question that arises with this issue is about when to do the software vendor qualification. If the software is bought from outside, it is understood that it should already have been built to meet standards. What happens once the software starts getting implemented into the company’s systems?

A thumb rule that many medical device companies follow to avoid getting cited from the FDA is this: they ensure that the vendor’s validated system demonstrates “systematic, high quality software specification, development and testing methodologies, together with documentary evidence that they have been followed”. This is the yardstick by which FDA measures software vendor qualification, because to it, any validated system that fails to demonstrate this is considered as not valid.

References:

http://ieeexplore.ieee.org/xpl/login.jsp?tp=&arnumber=263005&url=http%3A%2F%2Fieeexplore.ieee.org%2Fxpls%2Fabs_all.jsp%3Farnumber%3D263005

http://tech.groups.yahoo.com/group/21cfrpart11/message/10728

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Excel spreadsheet validation to eliminate 483s

One of the basic issues for organizations in the regulated area is to carry out Excel spreadsheet validation to eliminate 483s.

Why is this so? The FDA requires validation of electronic records, and this is a key requirement. The FDA has its set of regulatory requirements set out in 21 CFR Part 11. This code requires pharmaceutical, biotech, medical device, CRO, life sciences or related FDA-regulated organizations electronic records to be compliant with it. From this, the importance of Excel spreadsheet validation to eliminate 483s can be understood, because configuring an organization’s Excel spreadsheet application is a key requirement.

Making electronic records as genuine as physical records

21 CFR Part 11 is a set of FDA requirements, with which organizations have to comply to demonstrate that the electronic records they use are as good as the same as paper records in terms of genuineness. This is a core requirement for ensuring that electronic records do not get manipulated.

It is to nullify the drawbacks of using electronic records that 21 CFR Part 11 has to be implemented. One of the important aspects of 21 CFR Part 11 is Excel spreadsheet validation. Organizations need to know how to do Excel spreadsheet validation to eliminate 483s. The important benefit of being compliant is that it not only helps organizations avoid 483’s; when done properly, it saves two-thirds of the validation time and costs.

What does it take?

If an organization has to use Excel spreadsheet validation to eliminate 483’s, it needs to:

  • Know what does and does not need to be validated.
  • Know how to configure spreadsheet applications for Part 11 compliance
  • Have an understanding of how to use Excel’s built in 21 CFR Part 11 features for audit trails, security, data verification, and multiple concurrent users
  • Use risk assessment to reduce testing and improve productivity.
  • Specify and test its own GxP Excel application
  • Create a User Requirements document for the application
  • Create a Project Plan document for the application
  • Create a Functional Specifications document for its application
  • Create a Hazard Analysis document for its application
  • Create a Testing Protocol document for your application

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539