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.

Understanding 21 CFR Part 11 compliance for software validation and SaaS/Cloud

Understanding 21 CFR Part 11 compliance for software validation and SaaSCloud4

Software as a Service, SaaS is a method of delivering applications over the Internet. This small definition just about summarizes the core of SaaS: It provides Software as a Service using just the Internet. SaaS applications go by different nomenclatures such as on-demand software, hosted software, or web-based software.

SaaS is a fundamentally different method of delivering applications, because when a client chooses SaaS; there is no need to install and maintain software. It can be accessed with just an Internet connection. SaaS applications can be run on the provider’s servers. Since it is the provider who takes over the responsibility of managing all aspects of the application, such as making it available and secure, and also for its performance; the client is spared the headache of having to manage unfamiliar and often complex software and hardware.

This sunny side of SaaS appeals to many clients, which is the primary reason for which SaaS is a huge market. From over $ 10 billion in 2011 in the US; the global SaaS market is set to grow to around $ 120 billion by 2019. Speculated to grow at a CAGR of anywhere between 18 and 24 percent; SaaS is estimated to make up more than one fifth of all software services by that year.

The difficult side of SaaS

Understanding 21 CFR Part 11 compliance for software validation and SaaSCloud2

This makes the prospects for the SaaS market very bright. However, there is a catch: Most SaaS providers outsource their resources to cut costs. This activity exposes them to the seamy side of this exploding market. Most regulations such as 21 CFR Part 11 are only for the provider, and very little of these are for the vendor. Since there is very less regulation that will offer safeguards to the user from the vendor; the onus of ensuring compliance for both infrastructure qualification and Computer System Validation lies with the regulated company, for it is they who have to show compliance with the regulations and prevent issues relating to availability, performance and protection of data.

Failure in doing so hurts their reputation, because it is they, and not the vendor, that is regulated. This regulated provider is the one that becomes the target of FDA inspections on software validation and should hence do everything it can to avoid FDA actions such as Warning Letters and 483’s. There is thus a major need for regulated companies, software vendors and SaaS/cloud providers to show compliance with 21 CFR Part 11 and other regulations such as Annex 11. This is the only way to avoid legal and other issues associated with noncompliance.

Learn the ways of staying compliant

Understanding 21 CFR Part 11 compliance for software validation and SaaSCloud1

How do regulated companies, software vendors and SaaS or cloud providers ensure compliance and safeguard and enhance their reputation as trustworthy providers? It is this critical issue that will be discussed threadbare at a very useful and educative two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory industries.

At this seminar, David Nettleton, who is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and Computer System Validation, will be the Director.

Want to understand how David explains the way by which regulated companies can offer legally compliant SaaS and cloud solutions? Then please register for this seminar by logging on to Understanding 21 CFR Part 11 compliance for software validation and SaaS/Cloud. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Demonstrating proven techniques

Understanding 21 CFR Part 11 compliance for software validation and SaaSCloud5

The purpose of this seminar is to demonstrate proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Towards imparting this, David will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and Computer System Validation.

With the FDA performing both GxP and Part 11 inspections; the EMA has released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. David will discuss this. He will give participants an understanding of the specific requirements associated with local and SaaS/cloud hosting solutions.

Validation in a number of specialized areas

Since almost every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated; the ways by which they can decrease software implementation times and lower costs using a 10-step risk-based approach to Computer System Validation will be imparted. The Director will review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.

Anyone who uses computer systems to perform their job functions in the regulatory, clinical and IT areas of health care, clinical trial, biopharmaceutical, and medical device sectors will find this seminar highly useful. It is of high value for software vendors, auditors, and quality staff involved in GxP applications.