Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements

Scheduled On : Wednesday, December 4, 2013 at 10 AM PST | 1 PM EST
Duration : 90 Minutes

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Description : 

This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new components to network, back-up of data, access control, rules for passwords, and audit trails. Case studies will be used to highlight common issues and potential solutions.

21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However, for any organization trying to understand and implement Part 11 requirements, there are only two options: One, hire expensive consultants and purchase expensive software, or implement self-created systems and live in constant fear of findings of non-compliance during FDA audits. In this seminar, we will simplify the regulatory requirements and add practical tips for quick and easy verification of compliance with FDA requirements which can be self-implemented by most organizations with minimum technical expertise.

Areas Covered in the Session :

• Part 11 requirements by FDA
• Applicable systems per the FDA
• Validation of computer systems
• Network set-up, maintenance, integrity check and security
• Common elements of Part 11 complaint computer systems
• Building Part 11 compliant systems bottom-up and top-down.
• Back-up and re-creating data
• Verifiable audit trails
• Electronic signatures and certificates
• Best practices for using non-networked computers

Who Will Benefit: 

This webinar will provide valuable information to:

• FDA-regulated labs, clinical trial sites, manufacturers, and sponsors
• Everyone involved in computer system validation
• Anyone selecting computer systems intended for FDA regulated environments
• Information technology professionals responsible for files or network locations
• Quality professionals who organize, document and verify system compliance
• Executives evaluating requirements Part 11 compliant systems

Speakers Profile

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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Herman Wong is a Washington DC-based consultant for computer systems in FDA-regulated industry. He has been in the industry for over 12 years and leads the Information Technology department at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in training of IT personnel in FDA-regulated industry, creating, managing and implementing Part 11 compliant computer systems. Since 2005, Mr. Wong has been evaluating EDC systems for Part 11 compliance at small and big organizations including some of the largest US federal organizations and large pharmaceutical companies.

Compliance Update: FDA approves medical device to treat epilepsy

The U.S. Food and Drug Administration approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.

The RNS Stimulator consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.

Epilepsy produces seizures affecting varied mental and physical functions. Seizures happen when clusters of nerve cells in the brain signal abnormally, which may briefly alter a person's consciousness, movements or actions. According to the Epilepsy Foundation, epilepsy affects nearly 3 million people in the United States and is the third most common neurological disorder, after Alzheimer’s disease and stroke. Approximately 40 percent of people with epilepsy are severely affected and continue to have seizures despite treatment.

The FDA’s approval is supported by a three-month randomized control trial of 191 patients with drug-resistant epilepsy.

The study showed that by three months after the implanted device was turned on (active use) patients experienced a nearly 38 percent reduction in the average number of seizures per month, compared to an approximately 17 percent reduction in the average number of seizures per month in patients who had the implanted device turned off. At the end of three months, the median reduction in seizures, which reflects a more typical patient experience, was 34 percent with active use and about 19 percent with the device turned off. During the trial, 29 percent of patients with an active device experienced at least a 50 percent reduction in the overall number of seizures, compared to 27 percent for those with the implanted device turned off.

During a two-year follow-up phase (unblinded), data demonstrated a persistent reduction in seizure frequency.

Patients with RNS Stimulators cannot undergo magnetic resonance imaging (MRI) procedures, nor can they undergo diathermy procedures, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS). The energy created from these procedures can be sent through the neurostimulator and cause permanent brain damage, even if the device is turned off.

The most frequent adverse events reported were implant site infection and premature battery depletion.

Source: FDA

For more updates and trainings on FDA regulated industries, visit Compliance Trainings

FDA slaps 'deadly' tag on Atossa's cancer Dx recall

The FDA has applied its most serious label to Atossa Genetics' ($ATOS) recall of a breast cancer diagnostic, warning that using the unapproved devices could lead women to forego treatment and increase their risk of serious injury and death.

Atossa voluntarily recalled the ForeCYTE Breast Health Test last month after a February FDA warning letter chided the company for marketing its system without agency clearance. Atossa billed its test as a tool to determine patients' cancer risk by screening small amounts of nipple aspirate fluid, but the company never secured the FDA's backing for those claims.

Now, the agency has applied a Class I label to the recall, warning that using ForeCYTE as a stand-in for mammography or other diagnostic procedures could put patients at serious risk. False positives could spur needless anxiety and unnecessary medical costs, the FDA said, while false negatives could lead to delayed diagnosis and treatment of breast cancer, increasing chances of death.

Atossa has said it's working with the FDA to get its banner product back on the market, but it may be difficult to reverse the damage, and the company's shares have fallen roughly 60% since October. The recall came amid Atossa's nationwide commercial scale-up for ForeCYTE, following partnerships with distribution giants McKesson and Thermo Fisher ($TMO) to spread the system around the country. The company believed its test had a chance to become as ubiquitous as the Pap smear, CEO Steven Quay said.

Atossa has said it hasn't heard of any adverse events tied to ForeCYTE, and the FDA is asking patients and physicians to report problems through its MedWatch platform.

Source: FDA

For more updates and trainings related to FDA, visit Compliance Trainings.

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Medical Devices and Pharmaceutical Quality Management System - Applying the Principles of Lean Documents and Lean Configuration

Scheduled On : Wednesday, November 20, 2013 at 10 AM PST | 1 PM EST

Duration : 60 Minutes

Description : 

The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push" systems, many traditional document practices are artifacts of a flawed approach.  Lean documents presents a fresh departure from these practices, while building upon proven principles. Lean configuration comes from the same principles, utilizing the unique power of software solutions to take over functions that had previously burdened controlled "paper" documents.

Do you find yourself constantly struggling to create, manage, and maintain all of the information found in the documents of a typical QMS - which is often redundant, repetitive, and chained together in a cumbersome way?

Do you find that your design and manufacturing resources are spending way too much time on documentation and not enough on design, manufacturing, and supplier management?

This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.

Areas Covered in the Session :

• Brief introduction to Lean Documents and Lean Configuration
• Quality System Regulation, 21 CFR Part 820, ISO 13485, ICH Q10 Pharmaceutical Quality System
• Key elements of a Quality Management System (QMS)
• Applying lean principles to medical device QMS documents
• Applying lean principles to pharmaceutical QMS documents

Who Will Benefit: 

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Quality Engineering
• Operations
• Document Control
• Lean Program Leaders

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Speaker Profile

José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with ....more

Robust Corrective And Preventive Action (CAPA)

Scheduled On : Tuesday, November 12, 2013 at 10 AM PST | 1 PM EST
Duration : 90 Minutes

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Description : 

Vital elements of a robust, "bullet-proof", "closed-loop"  Corrective and Preventive Action (CAPA) program include: "Gatekeeper" capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis. Such a "closed-loop" CAPA system will meet / exceed CGMP requirements and U.S. FDA expectations. Robust CAPA requires a specific sequence of activities, each building on the other, to enhance patient safety and improve product quality.

It is also key to many other important cGMP activities -- Non-conformance / OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, other Verification and Validation activities, Audit corrective and preventive actions, et al. Simple tools and work flow are not understood, diseminated, and used, consistently.  Product failures, liability issues, scrap / waste / fall off, and needless recalls result, as evidenced in recent notorious events.

Avoid a "shoot from the hip" approach.  Define, then attack, and resolve root problems / causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of the "closed-loop" CAPA system.


A robust CAPA requires repeatable, systematic Failure Investigation and Root Cause Analysis. The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for reslution of the key underlying problem -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s) -- using a repeatable system.

The most important area audited by the FDA is CAPA -- it assures the FDA that company is in compliance without the Agency constantly auditing it. One of the most cited 483 observation is failure to resolve the key underlying problem and close out CAPA documents in a timely manner -- basically an inability to define, locate and resolve the basic problem(s) or root cause(s). Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.

Areas Covered in the Session :

• Regulatory "Hot Buttons"
• CAPA Background
• Correction, Corrective Action, Preventive Action Defined
• Impact Analysis and Response - a Key Component
• CAPA System Assessment
• "Bullet-Proof"
• Data Sources / Metrics
• Monitor for Effectiveness
• "Closed-Loop" - Lock In the Change
• Beyond Regulatory Compliance

Who Will Benefit: 

This 90 minute in-depth webinar will provide valuable assistance to all regulated companies that need to review and modify their company's CAPA system.

Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operators
• Consultants
• cGMP instructors

And all personnel involved in verification and/or validation planning, execution and documentation.

Speaker Profile

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.