Taking a QbD Approach to Build a Risk Based Strategy for the Development & Validation of Validation of Analytical Methods

Building a goal oriented pathway into which proper design precedes development activities for various Analytical and Test Methods as a means for building Quality into the method right from the start is extremely crucial. This is emphasized by The American Chemical Society (ACS), and is the nucleus of pharmaceutical Quality by Design (QbD).

So, how does one understanding QbD? QbD is a systematic approach towards development that is built on a set of predefined objectives. It informs a proper and thorough understanding of product and process, and process control, all of which are built on the edifice of sound science and quality risk management. QbD has been acquiring a position of preeminence in enhancing the quality, safety and effectiveness of the drugs being supplied to the patient. Its potential in bringing about substantial improvements into the quality performance of the manufacturing process is also gaining ground. Read more

Validation is aligned to QbD

Taking a QbD Approach to Build a Risk Based Strategy

The indispensability of Validation as a tool in demonstrating that the desired method is appropriate and sufficient for the purpose it is meant to serve is emphasized by the ACS. In order to achieve this, the organization has to build a risk based strategy for developing and applying these methods for their intended purpose during the entire lifecycle of these methods.

Meeting regulatory requirements through a risk based strategy 

Know real-life analytical problem solving and Method Development methods. how to create an appropriate Validation schematic and the Validation Protocol.

While imparting an understanding of the fundamentals of Quality Assurance, Quality Control, and analytical methods validation, how can use these tools to enhance the quality of their analytical data submissions that fully company with the respective and relevant FDA, WHO and OECD regulatory compliance directives.

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All the steps about conceptual framework which helps build documentation of practical applications that lead to data handling, Data Integrity, Validation Protocol and other documentation, even as all of them meet regulatory requirements.

An understanding of the extensive guidance for preparing Methods Validation Protocols for the various stages of regulatory submissions, e.g. IND, NDA, ANDA, PAI, CMC, etc., and the other aspects of Laboratory Controls (CGMP), QC procedures, SOPs that cover calibration, standardization, Qualification and Validation, as well as statistical tools, SQC, SPC for processing and monitoring of analytical data; are part of the way to learning and explore your knowledge for better results.

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FDA Warning Letters – an understanding

As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority.

The FDA issues a Warning Letter to a company when it determines, following its inspection of a facility from an industry that it regulates, that the facility is violating some or other terms of the provisions of the FDA Act. The FDA Act is a legislation that gives the FDA the authority to carry out its inspections.

fdaWarningLettersThe issuance of an FDA Warning Letter is an indication that the facility is practicing some degree of nonconformity. A Warning Letter is among the FDA’s strongest tools of ensuring voluntary compliance from organizations with the provisions of the FDA Act.

The FDA publishes on its website any deviances of regulatory significance that it discovers from a facility during its investigations. In its viewpoint, a deviation of regulatory significance is one that leads to enforcement actions if the facility fails to carry out corrective action of whatever violations the FDA has documented.

Types of Warning Letters from the FDATo enable the public and concerned parties to view the Warning Letters it issues from time to time; the FDA has classified these on its website in the following manner:

fdaWarningLettersA General Warning Letter is one that is issued to a company in whose activities the FDA notes significant variations from the principles laid out in the FDA Act. The Warning Letter carries a description of the variation or violation that the manufacturer has been practicing, along with a description of what actions needs to be taken to correct it.

Tobacco Retailer Warning Letters are those that are issued to manufacturers of products made out tobacco, such as cigarettes, smokeless cigarettes and related ones, who are found to be violating the provisions of the FDA’s Tobacco Control Act and with provisions of Title 21 of the Code of Federal Regulations, Part 1140 (21 C.F.R. Part 1140).

Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies) are those Warning Letters that the FDA website sorts out by month and consist only of Division of Drug Marketing and Communications and Drug Warning Letters. This kind of Warning Letter is issued to sellers of prescription drugs online when they are found to violate terms set out by the FDA.

Warning Letter closeout program
fdaWarningLettersWhen the FDA issues a Warning Letter to a facility that comes under the various classifications; it follows up with it from time to time to ensure that the suggestions it advises are carried out. When the facility has carried out the necessary corrective actions; the FDA issues the Warning Letter Closeout, which closes the matter associated with the Warning Letter until the next FDA inspection.

Methods of issuing Warning LettersIt is only when it discovers violations that the FDA issues Warning Letters. It is through inspections that it discovers violations, from which Warning Letters follow. However, the FDA can also issue Warning Letters to facilities about which its receives complaints of wrongdoing from state personnel.

An FDA Warning Letter is not an enforcement action
fdaWarningLettersIn the perspective of the FDA; a Warning Letter is of an informal and advisory nature. An FDA Warning Letter is a description of the violation observed at a facility; but this in itself does not make the FDA take enforcement action. Rather, through a Warning Letter, the FDA advices the organization on what steps it has to take in order to rectify and correct the reasons for which the Warning Letter was issued. An FDA Warning Letter offers the organization enough opportunity to take corrective action that is of a voluntary and appropriate.

 

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Understanding the infinite area of medical device compliance

Understanding the infinite area of medical device compliance 1.pngWith a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic.

With the FDA being the sole regulator for this very vast area; it comes up with regulations, and expects medical device manufacturers to comply with them. This is part of the FDA’s primary function of assuring quality from medical devices. Compliance with these medical device regulations ensures that companies’ products meet the quality and safety and integrity of medical devices.

Areas of medical device compliance regulations

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The FDA’s regulation of medical devices and a few nonmedical devices cover the areas of manufacturing, repackaging, and relabeling, and/or importing. The regulations for medical devices are set out in 21 CFR Part 807, whose various sections detail all the requirements for compliance for Class I, II and III medical devices. The following are the activities connected with compliance for medical devices:

  • Registration of the establishment
  • Listing of the medical device
  • 510 (k)
  • Premarket approval
  • Investigational Device Exemption (IDE)
  • Quality Systems
  • GMP
  • Device labeling
  • Device reporting.

A thorough understanding of the FDA medical device compliance areas

Understanding the infinite area of medical device complianceThe ambit of the FDA’s regulations being very wide; it is important for medical device companies to have clarity on the many FDA medical device compliance regulations. This understanding will be offered at a seminar being organized by GlobalCompliancePanel, a very well-known provider of professional trainings for the areas of regulatory compliance.

The Director of this two-day seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc.

Please register for this webinar by visiting Understanding the infinite area of medical device compliance . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Helping to strategize compliance for medical devices

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Medical device companies need to put in place a sound strategy for medical device compliance. A certain level of strategic thinking alone ensures this. Susanne will show participants how to inculcate this thinking and instill it into the organization. She will show how to be cost-effective while improving the quality and compliance of medical devices. The ways of building a sound Quality System, which is at the root of medical device compliance; will be imparted.

An effective and efficient Quality System can only be implemented based on a thorough understanding of what the regulatory requirements mean, and adapting them into the Quality System. The ways of doing this will be the core of this seminar. Susanne will demonstrate the ways by which to plan, structure and implement a Quality System that addresses the specific business needs of the participants.

Addressing issues within a Quality System

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The methods for identifying, prioritizing and analyzing risks will be explained during the discussion on how to create a quality strategy and plans. Susanne will help participants explore the capabilities needed for every medical device to meet quality standards and implement compliant Quality Systems.

Also taken up for discussion are areas related to continuous improvement, Six Sigma, and Corrective and Preventive Action (CAPA), which are important components for addressing issues within a medical device company’s Quality System. Susanne will help with this very important aspect.

Over these two days, Susanne will also take up other crucial aspects of medical device compliance. These include:

  • Effectively communicating and escalating risk
  • Monitoring performance and progress
  • Kick starting the Quality System to avoid common problems such as MDRs, recalls, 483s, and Warning Letters.

Susanne will cover the following areas at this seminar on medical device compliance:

  • Quality System Expectations
  • Quality System Structure
  • Strategy and Planning
  • Risk management in your quality system
  • Case for Quality
  • Inspection preparedness and management
  • Monitoring and metrics
  • Creating a quality strategy and plans.

continue to improve the medical device compliance

 

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

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The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:

  • The aging population
  • The huge spending power of one of the world’s largest economies
  • The infusion of new technologies into the field of medical devices, which pushes up costs initially
  • The high proportion -nearly a quarter of the entire market -of imported medical devices, especially from the US, which introduce sophisticated, technology-driven products of higher price into the market

Japan’s classification system of medical devices, which classifies these products into Class I, Class II, Class III and Class IV; varies from that of the US or the EU. Adherence to Japanese Industrial Standards, which define industry-wide safety and performance requirements, is mandatory for medical devices.

In addition, the Japanese medical devices market has been undergoing a few major changes. Medical device manufacturers have to deal with strict new package insert requirements. The Marketing Authorization Holder (MAH) system, which deals with licensing rules, have changed, requiring a new MAH License category for In Vitro Diagnostic (IVD) devices. New changes have been made into several other aspects of medical devices. These include:

Medical device manufacturers have to also reckon with expanded scope of third party certifications, and comply with rules for Software as a Medical Device and for transferring pre-market certifications.

Full explanation of the regulatory requirements 

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All these factors make it very important for medical devices that want to enter the Japanese market, to get a thorough understanding of the regulatory requirements. Complete understanding of all these and more will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry; will be the Director of this seminar. David carries an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance arenas.

 

Please log on to Regulatory Filing Requirements and Compliance Processes for medical devices in Japan to enroll for this highly valuable training session which will put the whole gamut of regulatory requirements for medical devices in Japan in perspective. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Understanding how to streamline the regulatory process

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By attending this seminar, participants will be able to get a proper grasp of the entire registration and approval process in Japan. They will be able to identify and understand the major changes to medical device registration process in Japan. This will help them to streamline the medical device registration process, which will help them to obtain approval for their product in the most cost-effective and timely manner.

 

At this highly interactive session, the Director will let participants discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions. This will be a very hands-on approach to helping them to review and discuss pain points, challenges and solutions.

David will cover the following areas at this seminar:

  • Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
  • In Japan, are medical devices required to be registered before they can be sold?
  • What are the different regulatory classifications for medical devices?
  • What are the different application categories for medical device registration?
  • What does the registration pathway look like for each regulatory classification?
  • What are the document requirements for notification for the various classes of medical devices?
  • What are other requirements that are necessary for approval in addition to the device application?
  • Is local testing (type testing/sample testing) required for registration?
  • When are clinical studies required for registration?
  • Is approval in the Country of Origin required for registration?

 

To join us for more information, get in touch

 

 

 

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

 

21 CFR Part 11 compliance requirements for software validation 1.jpgSoftware as a Service, SaaS, is a way by which applications are delivered over the Net. It provides Software as a Service using just the Internet, and hence the name. SaaS applications are known by varied names. On-demand software, hosted software, and web-based software are some of these.

Where SaaS differs as a method of delivering applications is that there is no need to install and maintain software at or from the client’s location. All that is needed to access all these is an Internet connection. The provider can run SaaS applications on his own servers. With the provider taking 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 hassle of having to manage unfamiliar and often complex software and hardware.

Given this novelty and ease of its application; SaaS has grown into a huge market. Its US market was estimated at just over $ 10 billion in 2011. In the next couple of years, the global SaaS market is set to grow to around $ 120 billion. Experts put its speculated CAGR at between 18 and 24 percent and expect SaaS to make up more than one fifth of all software services by 2019.

Now, the difficult part of SaaS

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All these bright spots about SaaS notwithstanding; it comes with a few hiccups. Given its nature, most SaaS providers outsource their resources to cut costs. This makes them very vulnerable, since most regulations, such as 21 CFR Part 11, apply only to the provider, and give little by way of safeguards to the vendor. With very less vigilance and scrutiny on 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.  In other words, while the actual work of SaaS is carried on by the vendor; it is the client who has to ensure compliance with regulations arising out of 21 CFR Part 11.

Since on paper it is the regulated provider to whom all the regulations apply; it becomes the target of FDA inspections on software validation. They have to show compliance with these regulations set out in 21 CFR Part 11 and other regulations such as Annex 11 if they have 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. This is the only way to avoid legal and other issues associated with noncompliance.

The ways of staying compliant

21 CFR Part 11 compliance requirements for software validation

This is what a two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory industries, will offer. This seminar will explain in-depth how regulated companies, software vendors and SaaS or cloud providers can ensure compliance and safeguard and enhance their reputation as trustworthy providers

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 of this seminar.

Please register for this webinar by visiting 21 CFR Part 11 compliance requirements 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.

An explanation of proven techniques

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Over the two days of learning at this seminar, David will demonstrate proven techniques for cutting costs associated with the implementation, usage, and maintenance of computer systems in regulated environments. In doing 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. Companies must update their systems and processes to maintain compliance. This aspect will be explained at this seminar. The Director will offer participants an understanding of the specific requirements associated with local and SaaS/cloud hosting solutions.

Validation in several specialized areas

The regulatory agencies require almost every computerized system used in laboratory, clinical, manufacturing settings and in the quality process to be validated. David will show the ways by which they can do this while decreasing software implementation time and lowering costs using a 10-step risk-based approach to Computer System Validation. He will review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.

This seminar is of high value to 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. Software vendors, auditors and quality staff involved in GxP applications will also derive high value from this seminar.

 

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Effective legal writing skills are essential for FDA submissions

professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA

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A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA are deeply technical in nature, because of which they make heavy reading. Being the product of studiously and meticulously carried out research and finding, these submissions are very scientific and technical. Mastering the art of making legal writing effective and embellishing it is necessary for those who make FDA submissions because this can make these documents lucid and pleasant.

It is the habit of most law schools to prepare future attorneys by teaching them the art of summarizing and sharpening intricate and heavy textual and academic matter into crisp, concise and credible arguments. It is in situations such as drafting responses and applications to FDA that these kinds of writing skills become vital. The FDA expects responses to their queries, or for that matter, any poser that requires a response, to be very exact, scientific and technical. So, developing the art of effective legal writing skills for FDA submissions is a big need for those who prepare legal documentations.

Ridding submission documents of heavy text

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Making submissions about the product apart; effective legal writing skills for FDA submissions need to be developed for another important reason. Companies have to paddle through a muddle of legally heavy, often confusing regulations, which are legally binding requirements that are based upon statutory laws and judicial opinions.

Professionals in the pharmaceutical and medical device companies are required to handle these and respond to these at the appropriate times. A firm grasp of the requirements for doing this is needed for clearly understanding how to frame persuasive arguments and to negotiate with the FDA.

Effective legal writing skills can contribute to success in FDA submissions

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Effective legal writing skills for FDA submissions can stand between the success and failure of many new drugs, biologic or medical device projects, because a document that is confusing and is laden with incomprehensible jargon confuses the regulatory authorities and could become a reason for rejection of the submission.

This is why the more persuasive and articulate these arguments; the greater the chances for the company’s products of getting approvals from the FDA. All these facts make the cultivation of effective legal writing skills for FDA submissions extremely important.

Major learning on effective legal writing skills for FDA submissions

Effective legal writing skills are essential for FDA submissions

The ways of making legal writing skills effective for FDA submissions will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

The Director of this highly important and rewarding session on legal writing skills for FDA submissions is Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com.  In order to get clarity on how to develop the right tools needed for effective legal writing skills for FDA submissions, please register for this webinar by just visiting Effective legal writing skills are essential for FDA submissions

Effective legal writing skills for FDA submissions improve the chances of success

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At this very valuable webinar on effective legal writing skills for FDA submissions, Robert will familiarize participants with the legal writing skills and practical techniques that will enhance their chances for success. Good regulatory writing may help to meet FDA branch-level requirements; but effective submissions that are laced with effective legal writing skills for FDA submissions can withstand scrutiny at the FDA Division level.

The seminar will be highly useful to any person working in Regulatory Affairs or Quality Management who is responsible for summarizing data and technical results, obtaining regulatory clearance or approval of a product, and selling or marketing regulated products. These include Regulatory Affairs professionals, Quality Assurance professionals, Marketing professionals, Scientific and Engineering/Product Development Managers, and Consultants to any regulated industry.

At this webinar, Michalik will cover the following areas:

Regulatory Filing Requirements for medical devices in Japan

 

Japan is the world’s third largest market for medical devices, after the US and Europe. Ironically, many of the world’s medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are relatively less complex than those of the US and Europe and other markets.

Regulatory filing requirements for medical devices in Japan start with passing what is called the Pharmaceutical and Medical Device Law (PMDL). To facilitate better understanding of the language and to make regulatory filing requirements for medical devices in Japan easier, the Pharmaceuticals and Medical Devices Agency (PMDA), which is a part of the Ministry of Health, Labor and Welfare (MHLW) issues English language documents.

The “Toroku” registration processThe Japanese system for complying with regulatory filing requirements for medical devices has two different modes for domestic and foreign medical device manufacturers. For Japanese medical device companies, a registration system known as “Toroku”, which is formulated under the PMDL, applies. According to this process, domestic manufacturers whose manufacturing processes are based in Japan have to register their manufacturing facilities with the local authorities at their respective prefectures. For foreign manufacturers, the same have to be registered with the PMDA.

The step-by-step processThis is how the step-by-step process for regulatory filing requirements for medical devices in Japan takes place:

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