How to Create a Medical Software Development File – ISO 62304

Managers who deal with regulatory or quality guidelines or medical software for medical devices with software.

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The 62304 is a standard from the ISO which deals with the lifecycle management of medical software and the software used in medical devices. It goes without saying that risk management is central to the implementation of this standard and is inbuilt into it.

In the advanced medical devices markets of the world, such the European Union and the US, or Japan and China or just any other market, the application of ISO 62304 is mandatory for medical devices. They form a core part of the regulatory requirements of most of these markets. This means that medical device organizations who do not get their ISO 62304 implementation right face the risk of regulatory action.

The medical software development file is a very crucial component of the development process and the lifecycle of medical software in accordance with ISO 62304. How to apply the ISO 62304 in the medical software development process and how to create a medical software development file are thus very important to learn for medical device companies.

Compliance4All, a leading professional training platform that offers cost-effective learning on all the areas of regulatory compliance, is organizing a webinar on June 11, at which all the aspects of applying the ISO 62304 in the medical software development process and the knowledge of the right way of creating a medical software development file that meets regulatory expectations, will be taught.

At this webinar, Prof. Dr. h.c. Frank Stein, a very senior and highly respected medical device academic and professional, will be the expert. To enroll for this ninety-minute session.

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The essence of the learning this webinar will offer is that it will help participants understand what the ISO 62304 for medical software is, and how this standard works. Participants will gain valuable learning of how to apply the ISO 62304 in the medical software development process and how to create a medical software development file.

This will help them understand how to apply this standard smartly in a medical software development project during both the medical software development and in the post market process stages.

Prof. Dr. h.c. Frank Stein will cover the following areas at this webinar:

  • What is the scope of the ISO 62304?
  • What are the requirements of ISO 62304 in medical software development processes and the medical software life cycle?
  • Which companies must apply ISO 62304?
  • How to implement ISO 62304 in a smart way into a medical software development project and in a quality management system according ISO 13485?
  • How to use the ISO 62304 in the Post Market Process according ISO 13485 and the EU MDR?
  • What are the expectations of European Notified Bodies?

This learning is of invaluable assistance to professionals such as

  • CEO’s of companies which sell to Europe medical software or medical devices with software
  • Regulatory Affairs Managers of companies which sell to Europe medical software or medical devices with software
  • Quality Managers of companies which sell to Europe medical software or medical devices with software
  • Quality Representatives of companies which sell medical software or medical devices with software to Europe
  • Other Managers who deal with regulatory or quality guidelines or medical software for medical devices with software.

Please visit for more details

https://t2m.io/OOsUYhk2

Basic Supply Chain Food Safety Control Requirements 2019

With the finalization of the FDA’s FSMA Preventive Control Rules, new FDA outbreak testing technologies and increasingly complex supply chain controls, spices and other low moisture foods are becoming increasingly identified as outbreak contributors.

Spices are frequently found to carry salmonella, are full of physical adulterants, are often not identified as allergens, may be impacted by lead and, when not carefully controlled throughout the supply chain, represent a bacterial growth potential that can end up in processed foods.

Spice handling operations are subject to environmental facility controls, environmental sampling and test, process validation, Good Agricultural Practices (GAP), current Good Manufacturing Practices (cGPM), sanitary transportation rules, as well as packaging, labelling and other controls.

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Virtually all processed foods use spices to enhance flavors. Most spices used in the United States are imported, often from unknown, unregistered and unregulated farms prior to moving to larger handling and packing centres in the U.S. Most spices are grown and imported from tropical environments and are hand harvested with little or no food safety controls.

Knowing where and how spices are harvested and handled and the basics of spice food safety will prepare your company to prevent outbreaks that can destroy your company.

If your company is involved with spices in any way, you need to assure that you have appropriate food safety controls in place. With new reports becoming public, it is obvious that in spite of being classified “generally regarded as safe” (GRAS), spices are not as safe as previously thought.

This session will cover outbreaks as well as basic microbial reduction techniques, drying, testing, preventive controls, sanitation operation procedures, water issues, pest controls, storage, facility controls (air/dust/humidity), and other basic spice handling food safety considerations.

  • All Registered food Facilities involved with spices and Dried Herbs
  • Domestic Spice Receivers and Foreign spice Suppliers to U.S. markets
  • Spice Growers, Packers, handlers, Transporters
  • Processing, Carrier and Distributor Facility owners and Managers
  • Spice importers, Handlers, growers, and Packers
  • Food Safety and Quality Personnel whose operations are involved with spices
  • Process and facility sanitation and maintenance personnel
  • Spice purchasing and supplier qualification personnel
  • Company Compliance Officers
  • Internal and External Auditors
  • All Restaurant and Food retail store Owners and Managers

3-Hour Boot Camp for the Detection of Microbial Pathogens in Foods and Feeds

The session then describes how to confirm that results obtained by commercially-available kit, are comparable to or exceed those obtained using the reference method.

All methodologies described in this presentation are also used by FDA labs. FDA applies them to education, inspections, data collections, standard setting, investigation of outbreaks and enforcement actions.

This presentation uses the latest FDA thinking and guidance documents to assist you in re-establishing those requirements that need to be fulfilled in the evaluation for microbial methods used in your testing laboratories. It also re-establishes performance evaluation (verification & validation) criteria, necessary for the use of commercially-available diagnostic test kits and platforms.

The presentation further describes evaluation criteria for methods to detect, identify and quantify all microbial analytes that may now be, or have the potential to be associated with foods and feeds, i.e. any microbiological organism of interest (target organism) or the genetic material i.e. DNA, RNA, toxins, antigens or any other product of these organisms.

Session #: 1
Duration: 1 hour
Learning Objectives: This section sets the context for the overall presentation and then provides validation criteria and guidance for all FVM-developed or any existing method(s) that has been significantly modified.
Introduction

  • Purpose & Scope
  • Administrative Authority & Responsibilities
  • General Responsibilities of the Originating Laboratory
  • Method Validation Definition
  • Applicability
  • Requirements

Criteria and Guidance for the Validation of FDA-Related Methods

  • Validation Definitions
    • The Reference Method
    • The Alternate Method
    • The Originating Laboratory
    • The Collaborating Laboratory
  • The Method Validation Process
    • Emergency Use
    • Non-Emergency Use
  • Validation Criteria
    • Validation Criteria for Qualitative Methods to Detect Conventional Microbial Food-borne Pathogens
    • Validation Criteria for Identification Methods
    • Validation Criteria for Quantifiable Methods to Detect
    • Conventional Microbial Food-borne Pathogens
  • Method Validation Operational Aspects
    • General Considerations
    • Assessment of Validation Results

Session #: 2
Duration: 1 hour
Learning Objectives: This session describes guidelines intended to support method validation efforts for developers of molecular-based assays e.g. PCR, to be used to confirm the identity of exclusion of isolated colonies. Methodologies from this session can be used for either conventional or real time PCR assays.

The session then describes how to confirm that results obtained by commercially-available kit, are comparable to or exceed those obtained using the reference method.

Criteria and Guidance for the Validation of FDA-related molecular Based Assays

  • Inclusivity & Exclusivity
  • Target Genes & Controls
  • Comparison to the Reference Method

Criteria and Guidance for the Validation and Verification of Commercially Availbale Microbiological Diagnostic Kits and Platforms

  • Definitions
    • Validation of an Alternative Method
    • Verification
  • Criteria
    • Commercially-available Microbiological Diagnostic Kits Whose Performance Parameters Have been Fully Validated in a Multi- Laboratory Collaborative Study Monitored and Evaluated by an Independent Accrediting Body e.g. AOAC-OMA, AFNOR, etc.
    • Commercially-available Microbiological Diagnostic Kits Whose Performance Parameters are Supported by Data Obtained Through an Independent Laboratory Validation Protocol and Evaluated by an Independent Accrediting Body e.g. AOAC-RI

How to Find the Right “DIETARY SUPPLEMENTS” for Your Specific Product (Service)

These have to match what is specified in the master manufacturing record.

Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.

Please visit http://bit.ly/2DIk8lf to enroll for this webinar.

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How to find the right dietary supplements for your specific product (service) can be quite a challenge, if you are one of the players in the industry. The reason is this: manufacturers, labelers and packagers of dietary supplements, and even those who hold them, have to comply with the requirements set out in 21 CFR Part 111.

21 CFR Part 111, or what is called the “DS CGMP rule”, requires those who manufacture, package, label and stock dietary supplements to ensure the quality of the product by adhering strictly to the packaging and labeling requirements set out in this Part. These have to match what is specified in the master manufacturing record.

Till the FDA published the Dietary Supplements CGMPs as a “Final Rule”, which brought 21 CFR 111 into existence, the Quality Management Systems and controls on dietary supplements were loose and voluntary in nature. About the only requirement was the one set out by the Dietary Supplement Health and Education Act of 1994 (DSHEA), by which the Congress defined what is meant by a “dietary supplement”, and only required that every supplement be labeled a dietary supplement.

Complying with 21 CFR 111 is not optional

All that has changed with 21 CFR 111. To start with, the FDA now has a set of regulations for dietary supplements that is different from what is set out for conventional foods and drug products.  And then, players in the dietary supplements field that fail to comply with these requirements can have their products termed “adulterated” or “misbranded” by the FDA.

Despite the introduction of this Part, considerable confusion abounds in the industry as to just what type of manufacturing controls and record keeping, and labeling content the FDA requires, with the result that this Part continues to be a regulatory sore point for many new and established companies in the industry.

It is this confusion that this webinar seeks to clarify. John E. Lincoln will help participants of this session resolve these issues.

John will explain all the aspects of FDA Part 111, which will include Quality Management System/Quality Assurance/Quality Controls, personnel, facilities, equipment, software controls, production and Process Controls, holding and distribution, complaints and returns, and records.

At this 90-minute webinar, which is aimed at benefiting Senior Management in the dietary supplements industry, QA/RA, R&D, Consultants, those in Engineering and Marketing, those tasked with Product, Process, Validations and CGMP responsibilities, as well as other interested consumer groups, medical and other healthcare professionals, staff and office personnel, and start-ups, John will cover the following areas:

  • History of Dietary Supplement regulation in the U.S
  • The Dietary Supplement Health and Education Act (DSHEA)
  • The key requirements of the Dietary Supplements CGMPs, 21 CFR 111
  • Required steps for CGMP compliance
  • Problem areas, common pitfalls
  • Implementation: Systems, templates and tools.

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About the speaker:

John E. Lincoln is a graduate of UCLA. His experience also includes managing pilot production, regulatory affairs, product development/design control, 510(K) submissions, risk management per ISO 14971, and projects. He brings over 28 years of experience in the FDA-regulated medical products industry, during which he has worked with companies ranging from startups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt.

GMP Expectations for Products Used in Early Phase IND Studies

GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

  • Discussion of the elements found in the guidance document for Phase 1 material
  • What to do at really early stages
  • What about special IND studies?
  • What about preclinical studies?
  • Varying GMP activities that depend upon the nature of the IND product
  • What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
  • What to do about QC activities such as instrument qualification, method validation, and process validation

These guidelines remove some of the problems https://goo.gl/9qYuLa

What is GDPR and How to Comply and How to Protect Privacy?

When not implemented properly, can lead to havoc for the company.

A core law concerning the protection of data of all people living in the European Union (EU) is the General Data Protection Regulation (GDPR). The GDPR, which is codified as Regulation (EU) 2016/679, has been formulated to fulfil two important purposes:

  • Placing the control of personal data in the hands of citizens and residents of the EU
  • Easing the regulatory process and environment and standardizing and unifying data protection regulations across the EU with the aim of making global business within the EU easier.

The legislative and secretarial bodies of the EU, i.e., the European Parliament, the Council of the European Union and the European Commission, consolidate and strengthen all aspects relating to data protection for all individuals within the European Union (EU) through the GDPR regulation.  The GDPR also addresses the area of export of personal data to regions outside the EU.

GDPR-and-DPIA-Data-Protection-Impact-Assessment-What-the-DPIA-should-contain-at-least-according-to-Article-35-of-the-GDPR-General-Data-Protection-Regulation

Gain complete understanding of the GDPR

With the GDPR now being the law that companies that want to do business in the EU have to comply with; it is necessary for them to get proper and thorough understanding of all its elements. This learning is what a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Derk Yntema, who has over 15 years of experience in ICT and security-management and has demonstrated capacity to implement innovative security programs that drive awareness towards information security and strengthen organizations and proven knowledge of privacy legislation and helping companies towards privacy compliance. Please visit http://bit.ly/2JurJbE to enroll for this webinar and get a full and proper understanding of the GDPR and how it matters to your business.

Explanation of the advantages and disadvantages of the GDPR

Derk will explain all the aspects of the GDPR, including its benefits and drawbacks. Among the advantages it carries are the greater and clearer insight it offers into Personally Identifiable Information (PII) processing within the company, the boost and synchrony it gives to security controls across the 27 EU members, the increased customer confidence that accrue from stronger safeguards for data protection, and the simplification of the process of doing business in the EU.

However, the GDPR, when not implemented properly, can lead to havoc for the company. It can result in unimaginably high levels of penalties, up to two percent of violating companies’ worldwide revenues, fines of up to € 20 million, complicated lawsuits, loss of reputation, and many liability cases.

The insights that Derk will offer at this webinar will help participants understand how to comply with the regulation in such a manner that their organizations fully derive the benefits of this regulation and neutralize the negative effects of not doing it right.

He will cover the following areas:

  • What is Privacy?
  • How to Protect Privacy
  • What is PII?
  • What is in the GDPR (General Data Protection Regulation)
  • How to Comply.

This webinar is of very high value to professionals such as Board of Directors, Supervisory Board, CxO’s and Compliance Managers/Officers.

http://data.consilium.europa.eu/doc/document/ST-9565-2015-INIT/en/pdf

http://mlawgroup.de/news/publications/detail.php?we_objectID=227

http://www.eugdpr.org/

https://goo.gl/forms/pYroJzGipxGafw4A2 For updates Please fill this

What is FDA regulation of combination products?

Different parts of the combination product meet different proprietary purposes or serve different kinds of benefits.

First, what is a combination product? FDA’s 21 CFR 3.2 (e) describes a combination product as a product that has any of these combinations: a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.

Lines of distinction are blurring

With the recent technological advancements in the way drugs are combined; there has been a steady increase in the number of combination products the FDA has been getting and expects to receive for review. Historically, the FDA’s medical product centers, such as the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) have been tasked with the approval of combination products. However, in the near future, FDA regulation of combination products is likely to undergo a vast change, as strict segregation of these bodies has given rise to challenges related to regulation, policy, and review that need to be addressed.

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FDA regulation of combination products covers all aspects of the development and management of combination products, such as clinical investigation, pre-clinical testing, manufacturing and quality control, marketing applications, promotion and advertising,adverse event reporting, and post-approval modifications.

Marketing applications are the backbone of FDA regulation of combination productsFDA regulation of combination products requires all combination products to fulfill marketing applications. This is what enables it to be certified as fit for marketing. A single marketing application or separate one can be made for different parts of the combination product, for its marketing application to get approved.

In most cases, more than one marketing application gets filed when the different parts of the combination product meet different proprietary purposes or serve different kinds of benefits. It is also possible that when any of the individual parts making up a combination product has already been approved for another use, multiple marketing applications are made out as part of FDA regulation of combination products.