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.

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.

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How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Course “How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

• This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
• Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
• The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
• Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
• This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.
• Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated.
• Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
• Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
• This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

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Course Objectives:

• Understand what is expected in 21 CFR Part 11 and Annex 11 inspections
• Avoid 483 and Warning Letters
• Learn how to buy COTS software and qualify vendors.
• Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
• Requirements for local, SaaS, and cloud hosting
• How to select resources and manage validation projects
• “Right size” change control methods that allows quick and safe system evolution
• Minimize the validation documentation to reduce costs without increasing regulatory or business risk
• Write test cases that trace to elements of risk management
• Protect intellectual property and keep electronic records safe

  Day 1 Schedule

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  Day 1 (8am to 5pm; 0.5 registration, 1.0 lunch, 0.5 (2-15min) breaks, 7.0 class = 9.0)
  8:00am to 8:30am registration
  8:30am class starts

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  Lecture 1:
  Introduction to the FDA (1:30) {1:30}

  • How the regulations help your company to be successful
  • Which data and systems are subject to Part 11

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  Lecture 2:
  21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures (4:00) {5:30}

  • What Part 11 means to you, not just what it says in the regulations
  • Avoid 483 and Warning Letters
  • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
  • How SaaS/cloud computing changes qualification and validation
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents

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  Lecture 3:
  The Five Keys to COTS Computer System Validation (0:30) {6:30}

  • The Who, What, Where, When, and Why of CSV

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  Lecture 4:
  The Validation Team (0:30) {7:00}

  • How to select team members
  • How to facilitate a validation project

  Day 2 Schedule

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  Day 2 (9am to 3:30pm; 1.0 lunch, 0.5 (2-15min) breaks, 5.00 class = 6.5)

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  Lecture 5:
  Ten-Step Process for COTS Risk-Based Computer System Validation (1:00) {1:00}

  • Learn which documents the FDA expects to audit.
  • How to use the risk-based validation approach to lower costs.
  • How to link requirements, specifications, risk management, and testing.
  • Document a computer system validation project using easy to understand fill-in-the-blank templates.
  • Based on: “Risk-Based Software Validation – Ten Easy Steps” (Davis Horwood International and PDA – http://www.pda.org, 2006).

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  Lecture 6:
  How to Write Requirements and Specifications (0:30) {1:30}

  • Workshop for writing requirements and then expanding them for specifications

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  Lecture 7:
  How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:00}

  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

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  Lecture 8:
  Software Testing (1:00) {3:00}

  • Reduce testing by writing test cases that trace to elements of risk management.
  • How to write efficient test cases

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  Lecture 9:
  System Change Control (0:30) {3:30}

  • How to manage a validated system with minimal documentation

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  Lecture 10:
  Purchasing COTS Software (0:30) {4:00}

  • How to purchase COTS software and evaluate software vendors.

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  Lecture 11:
  Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}

  • How to save money
  • How to increase quality
  • How to increase compliance with less documentation
    

    Carolyn Troiano

    Consultant, BrainStorm Central Consulting

    Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

    During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

   

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Proper Understanding of the US and EU Regulations on Combination Products

Businesses that want to register and maintain combination products in the US and the EU face two markets that are as different from each other as chalk is from cheese. These markets are not only not comparable to each other in about any parameter; their regulations are different from and independent of each other. Complete knowledge of the regulations in all their interpretation and nuances is necessary for businesses that want to market combination products into the US or the EU.

Only proper acquaintance with the existing regulations and their latest updates can help regulatory professionals and companies take the steps in ensuring that their products comply with regulatory requirements and meet quality standards. This is the rationale and the purpose behind the formulation of the regulations in the US and the EU by the respective regulatory agencies, the FDA and the EMA. These agencies seek to ensure that the end user consumes products that comply with the set scientific standards.

An understanding of the way in which they have evolved could perhaps throw some light on the diverse nature of regulations in these two markets: The FDA was primarily created as a consumer protection agency, while the EMA created its regulations with the intention of harmonizing the commercial and technological interests of the Member States.

The fundamental difference between the regulatory agencies is that the FDA is centralized, and regulates food and medicinal products within only one market, the US market, no matter how large it is. On the other hand, the EMA oversees as many as 28 members countries of the European Union, for all of which it makes and implements a synchronized set of regulations.

The EU’s September 2016 update

Any understanding of the regulatory aspect concerning combination products in the EU is incomplete without a reference to the compromise it reached in September 2016 through its two major legislative organs, the European Commission and the European Council. Relating to medical devices and invitro diagnostic (IVD) devices; this compromise, reached as many as four years after a deal was made, is a regulatory landmark.

It empowers the EMA to now assess and authorize high risk combination devices, such as implants. Formulated to replace the existing EU legislation on medical devices and in-vitro diagnostics, this update brings in greater uniformity and consistency in the assessment and approval process of high risk combination devices across the EU.

Proper understanding of the US and EU regulations on combination products

Documentation requirements and interfacing

These areas for learning:

• Documentation requirements for combination products EU
• Documentation requirements for combination products US
• Interfacing, development, quality, regulatory
• Managing third parties and document control.