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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Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. 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. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).

A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets their responsibility for meeting it. As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt.

New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

Why you should attend

FDA requires that all computer systems that handle data regulated by the Agency be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.

The guidance was revisited for its application to the medical device industry in the 1990s, as the first issuance addressed pharmaceuticals only. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many FDA-regulated organizations began seeking ways to move into a paperless environment.

This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures, but still remains somewhat confusing. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Who Will Benefit

• Information Technology Analysts
• Information Technology Managers
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors Engaged in Internal Inspection

Session 1 (90 Mins):

• FDA Regulatory Oversight
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• GAMP 5 Software Categorization
• System Risk Assessment

Session 2 (90 Mins):

• 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)
• Security, Access, Change Control and Audit Trail
• Validation Documentation

Session 3 (90 Mins):

• 7 Most Common Problems with Validation
• FDA Audit Preparation

Session 4 (90 Mins):

• Policies and Procedures
• Training and Organizational Change Management
• Industry Best Practices and Common Pitfalls
• Q&A

Speaker Profile

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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200+ followers. WOWWWWWW…

Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Statins ‘should be given to children with heart risks before the age of 10’

Statins should be given to thousands of children by the age of 10 under radical new NHS guidance.

GPs are being urged to identify those who have an inherited risk of high cholesterol, amid warnings that the vast majority of cases are going undetected.

Estimates suggest up to 260,000 people – including 50,000 children – are suffering from genetic deficts which affect the body’s ability to break down cholesterol.

New guidance from the National Institute for Health and Care Excellence (Nice) today says statins should be offered to such cases, to reduce their risk of heart or stroke in midlife.

Just 15 per cent of those with the condition are being treated for it, Nice said, including just 600 of 56,000 children with the genetic problem.

Family doctors are being asked to trawl records to idenitfy those with very high cholesterol levels.

Where levels of more than 9 mmol/l are found in those over 30, and those of 7.5 mmol/l are found in those under 30, high-dose statins should be offered, the NHS guidance states.

And it says gene tests should be used to find other family members – including those below the age of 10 – who are at such heightened risk that they should be put on medication.

Around 56,000 children are estimated to suffer from familial hypercholesterolaemia (FH), yet just 600 have been diagnosed, charities say.

The condition gives men a 50 per cent chance of suffering a heart attack or stroke before the age of 50, while women have a one in three chance by the age of 60.

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Orkambi Reduces Main Biomarker of CF, Vertex Says in Updated Results on Four Therapies

Orkambi (lumacaftor/ivacaftor) reduced levels of the main biomarker of the lung disease cystic fibrosis and improved the nutritional status of children with the condition, according to a Phase 3 clinical trial.

The results were part of a recent update that Vertex Pharmaceuticals provided on Orkambi and three of its other CF therapies, Kalydeco (ivacaftor), tezacaftor (VX-661) and VX-371.

Vertex conducted the Phase 3 trial (NCT02797132) of Orkambi to evaluate its effectiveness and safety in preschoolers with two copies of the CFTR gene’s F508del mutation. The 60 children were aged 2 to 5. Mutations of the gene cause CF by producing faulty versions of the CFTR protein.

An indication of Orkambi’s effectiveness in the trial was that it reduced the production of the children’s sweat chloride and improved their nutritional status.

A sweat test is the gold standard for diagnosing CF because people with the disease have more chloride in their sweat than those who don’t. As for nutrition, the thick mucus that CF produces in the digestive system can prevent patients from absorbing nutrients and fat properly, leading to difficulty gaining weight and slower growth. CF also produces the mucus in lungs and other organs.

The Phase 3 trial also showed that Orkambi was safe and that the children tolerated it well. Researchers reported no adverse events besides those seen in studies of patients aged 6 to 11.

Based on the promising results of the trial, Vertex plans to submit a New Drug Application on Orkambi to the U.S. Food and Drug Administration during the first quarter of 2018. It will also ask the European Medicines Agency to extend the therapy’s availability to very young children.

Another Phase 3 trial (NCT02412111) that Vertex conducted evaluated a combination of tezacaftor and Kalydeco’s ability to reduce respiratory problems in patients more than 12 years old.

The study included 151 participants at 68 sites in the United States, Canada, Australia, and the European Union. The patients had one copy of the F508del mutation and one copy of another CFTR mutation.

Eight weeks of treatment with the combo led to a negligible improvement in a measure of patients’ lung function known as forced expiratory volume in one second, or FEV1. This is the amount of air that people can forcefully blow out of their lungs in one second.

The combo did lead to a reduction in sweat chloride that was larger than Kalydeco generated alone, however.

Given the results, Vertex has decided not to continue pursuing regulatory approval for the combo. One reason is that most patients older than 12 are eligible to receive Kalydeco by itself.

The FDA is expected to make a decision by February 2018 on a related New Drug Application that Vertex has filed. That application involves using the tezacaftor-Kalydeco combo to treat patients aged 12 or older who carry two copies of an F508del mutation or one copy of an F508del mutation plus another mutation. The FDA is giving the request priority review.

European regulators are expected to decide whether to approve the combo therapy in the second half of 2018.

Vertex has completed enrolling children 12 to 24 months for another Phase 3 trial (NCT03277196) of Kalydeco. It will evaluate the therapy’s safety in children less than 2 years old with a CFTR gating mutation and an R117H mutation.

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Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach

Medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, the ISO 13485:2016, recognizes this fact. The disparate requirements of each regulatory system make it necessary for manufacturers to identify their roles, as well as the regulatory requirements for that role, and then incorporate them into their Quality Management System.

The various jurisdictions, however, deal with post-market device issues in diverse ways. Complaint management, Adverse event reporting and Recalls are three interlocking and interrelated processes that need to go into the QMS.

Corrective action and design changes, which are supporting QMS processes; also need to complement these three processes. And then, the regulatory requirements, which usually involve areas such as recordkeeping and reporting, also come in.

A course on how to implement an integrated QMS

GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a highly educative and valuable learning session on these primary and secondary QMS processes and the way they need to be understood and implemented in relation to the US, EU, and Canadian regulations.

Dan O’Leary, who is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, which focuses on analytic skills and a systems approach to operations management, will be the Director of this two-day seminar. Dan brings more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

Want to benefit from Dan’s rich experience and want to understand the way in which to implement an integrated QMS in which the various aspects of complaints, adverse reporting and recalls are built? Please register for this seminar by visiting Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Alignment with the FDA’s QMS

The extent of its alignment with the FDA’s Quality Management System (QMS) requirement is one of the highlights of the final version of the ISO 13485:2016 standard, which has now become available. The degree of alignment set out in 2016 version of 13485 may be significantly higher than that of the previous version of 2003; yet, there still do exist a few points at which it deviates from the FDA’s QMS. Companies that should comply with this standard have to keep this in mind.

Now that the ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and the new EU Medical Device Regulation have been introduced; companies need to update their QMS and integrate all of the elements if their implementation has to be effective and compliant. At this two-day session, Dan will provide the tools that the participants will need for this.

Upset man lost in thought having received bad news from his doctor

The agenda of this learning session will be the following:

• The Regulatory Structure
• FDA QSR
• ISO 13485:2016 and regional variants
• ISO 14971:2007 and regional variants
• Implementing MDSAP
• The EU Medical Device Regulation
• Servicing
• Identification of problems
• Servicing data analysis
• Input to the complaint process
• Complaints

Identifying complaints

• Evaluating complaints
• Investigating complaints
• Complaint data analysis
• Input to the corrective action process
• Input to the risk management process
• Corrective Action
• Developing the process
• Analyzing product and process information
• Determining subsequent actions
• Input to the design process
• Input to the risk management process
• Design and Design Changes
• Determining the need for a design change
• Documenting design changes
• Design change verification and validation
• Input to the risk management process
• Input to the pre-market submission process
• Risk Management
• ISO 14971:2007 and regional variants
• Incorporating post-market information
• Updating Pre-market Submissions
• US – The 510(k) guidance
• EU – Technical files and design dossiers
• Canada – License changes
• Adverse Event Reporting
• US – MDR
• EU – Vigilance Reports
• Canada – Mandatory Problem Reporting
• Recalls
• US – Corrections and Removals
• EU – Field Safety Corrective Actions
• Canada – Recall.

 

Click here to join us for more information, get in touch

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the new ISO version, the ISO 13485:2016. Because of the divergence in the requirements of each regulatory system; manufacturers are required to identify their roles, as well as the regulatory requirements for that role, and then incorporate them into their Quality Management System.

When it comes to post-market device issues; the various jurisdictions, however, deal with these in different ways. Three interlocking, interrelated processes need to go into the QMS:

• Complaint management
• Adverse event reporting
• Recalls

Supporting QMS processes such as corrective action and design changes also need to complement these three processes. Over and above the QMS processes come the regulatory requirements, which usually involve areas such as recordkeeping and reporting.

A complete learning on how to implement an integrated QMS

A highly educative and valuable learning session on these primary and secondary QMS processes and the way they need to be understood and implemented vis-à-vis the US, EU, and Canadian regulations is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

The Director of this two-day seminar is Dan O’Leary, who is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, which focuses on analytic skills and a systems approach to operations management. Dan brings more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

To understand the way in which to implement an integrated QMS in which the various aspects of complaints, adverse reporting and recalls are built; please register for this seminar by visiting An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Alignment with the FDA’s QMS is a major point

One of the highlights of the final version of the ISO 13485:2016 standard, which has now become available, is the extent of its alignment with the FDA’s Quality Management System (QMS) requirement. Although the degree of alignment set out in 2016 version of 13485 is significantly higher than that of the previous version of 2003; there still do exist a few points at which it deviates from the FDA’s QMS. Companies that are required to comply with this standard have to keep this in mind.

Now that the ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and the new EU Medical Device Regulation have been introduced; companies need to update their QMS and integrate all of the elements if their implementation has to be effective and compliant. At this two-day session, Dan will provide the tools that the participants will need for this.

The agenda of this learning session will be the following:

• The Regulatory Structure
• FDA QSR
• ISO 13485:2016 and regional variants
• ISO 14971:2007 and regional variants
• Implementing MDSAP
• The EU Medical Device Regulation
• Servicing
• Identification of problems
• Servicing data analysis
• Input to the complaint process
• Complaints

Identifying complaints

• Evaluating complaints
• Investigating complaints
• Complaint data analysis
• Input to the corrective action process
• Input to the risk management process
• Corrective Action
• Developing the process
• Analyzing product and process information
• Determining subsequent actions
• Input to the design process
• Input to the risk management process
• Design and Design Changes
• Determining the need for a design change
• Documenting design changes
• Design change verification and validation
• Input to the risk management process
• Input to the pre-market submission process
• Risk Management
• ISO 14971:2007 and regional variants
• Incorporating post-market information
• Updating Pre-market Submissions
• US – The 510(k) guidance
• EU – Technical files and design dossiers
• Canada – License changes
• Adverse Event Reporting
• US – MDR
• EU – Vigilance Reports
• Canada – Mandatory Problem Reporting
• Recalls
• US – Corrections and Removals
• EU – Field Safety Corrective Actions
• Canada – Recall.