FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation (CSV) and maintaining the system in a validated state throughout its life.

The SDLC approach takes all aspects of validation into account throughout the life of the system and protects the data that it houses through its retention period.  The data is a key asset for any FDA-regulated company and must be protected.  If data becomes invalid, based on improperly validating and maintaining the system that houses it in a validated state, the work related to the data would need to be repeated.  This could result in a devastating loss to any company’s bottom line.

We will discuss the key areas that are most important during inspection and audit, including security, data integrity, validation, training, and documentation.

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 session will provide some insight into current trends in compliance and FDA enforcement.  Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.  Others are based on factors including economics, social media, new diseases, politics, and a host of other influences.

Instructor:

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.

  • Information Technology Analysts
  • Information Technology Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists

Here to go in details

How the Things Will Change The Way You Approach [Phase I Gmps]

Including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

manufacturing

So, that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.

  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing
  • Quality Assurance, and Clinical Operations

The latest computer system industry standards for data [security]

Minimize the validation documentation to reduce costs without increasing regulatory or business risk.

Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.

The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

security

Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated.

Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.

Objectives of the Compliant with Part 11:

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

21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures:

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

Read more at http://bit.ly/2CVLELD_SaaS_Cloud

200+ followers. WOWWWWWW…

followed- 200

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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Design Control for Medical Devices

Design Control for Medical Devices 3

Design Control for medical devices is of utmost importance to the medical device industry. In order to get a grasp of its importance, one needs to get an understanding of what Design Control is. In simple terms, Design Control for medical devices is a set of logical and linear steps that medical device manufacturers have to take to ensure that:

  1. The medical device being manufactured is safe
  2. The medical device manufacturer follows all the steps and procedures for ensuring that the device it develops is what was meant to be developed
  3. Design controls for medical devices have to be put in place to ensure that the final product – the medical device – meets all the required and prescribed regulatory procedures and guidelines and meets the customer’s expectation

In short and simple terms, design controls for medical devices are verifiable and provable assurances that medical device manufacturers have taken adequate steps to guarantee that a medical device meets its set of required standards and procedures to ensure its safety and meet customer requirements.

FDA and ISO expectations of design controls for medical devicesBoth the FDA and the ISO have regulatory requirements from medical devices that expect some Design Control standards. The FDA’s requirements for design controls for medical devices are spelt out in FDA 21 CFR 820.30, while ISO 13485 is the standard for design controls for medical devices. Although formed by different regulatory or standards bodies; both the FDA 21 CFR 820.30 and the ISO 13485 are essentially similar. Their purview of the areas of design controls for medical devices is almost identically similar to each other. Sections of the FDA 21 CFR 820.30 and the ISO 13485 speak of requirements relating to the following in their various sections:

In just one area of design controls for medical devices, namely Design History File, there is a small difference, in that while the FDA’s regulatory requirements for design controls for medical devices include DHF; in the case of the ISO 13485, this is treated separately.

There is thus near total convergence between the FDA 21 CFR 820.30 and the ISO 13485 when it comes to design controls for medical devices.

Basic requirements of FDA 21 CFR 820.30 and ISO 13485Both the FDA 21 CFR 820.30 and the ISO 13485 have expectations for design controls for medical devices. These are the core areas:

designControlForMedicalDevices

Good Documentation Practice Guideline is simple: just write

Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.

Good Documentation Practices are essential for a number of disciplines. The soul of documentation is, naturally, the written word. What happens when something that happened is not actually written down? It is a work of no practical use, because apart from those that carried out the particular undocumented task; no one else is aware of it. And even when the people who did that task or were witness to it are prone to have their own interpretation and perception of what was done. This is why proof in the form of writing is the most important element of Good Documentation Practices.

goodDocumentationPracticesGuidelines

What to write, and how toGDP should not only be about just writing down; it is about what to write and also, how, meaning, in what manner. If there has been an intervention in any method of manufacture or any other activity in the regulated industries; the change should be noted down in the proper format as prescribed by the FDA. This enables everyone concerned, from the people in the organization to the auditors to the regulatory agencies, to clearly identify what action was carried out, by whom and when. This further leads to a discovery of the impact of the actions. This is the key to determining the effectiveness of the application of the GDP principles in the particular case.

goodDocumentationPracticesGuidelinesThis is why the FDA has very clear-cut requirements and expectations of GDP from the industries it regulates. These clearly explain the method by which to document the said document, the ways of doing it, and what actions to take when the need arises.

Quality Assurance is unthinkable without the application of GDP principles. The main reason for establishing GDP is ensure that the documentation does the following to the record in question:

goodDocumentationPracticesGuidelines
What needs to be documented?Another major element of GDP is to determine what is to be documented. The FDA and other regulatory agencies require the principles of Good Documentation Practices to be applied across a number of activities at different stages. These include:

goodDocumentationPracticesGuidelines

The EMA’s requirements
goodDocumentationPracticesGuidelinesThe EMA also has clear-cut guidelines on Good Documentation Practices. Some of its core requirements relate to

  • Specifications
  • All aspects of the manufacturing including the product’s formulae, the way in which the processing was done, the methods of its packaging, and the extent to which its testing instructions are written down
  • SOPs
  • Protocols
  • Technical agreements

Further, most regulatory agencies have their own requirements with regard to the styling, ways by which the amendments, if any, need to be jotted down, the type of ink to be used, the way in which the review, if any, needs to be entered, and who should put signatures and where, so on. Manufacturers who fall under the purview of respective regulatory agencies need to adhere to these.

And, for other reasons, as wellImplementing Good Documentation Practices is a great idea to have for meeting regulatory requirements, because companies that do not meet these requirements are in a spot of bother about a number of issues. However, in addition to this, there is also the need for maintaining GDP for business reasons, as well. A business that complies with the requirements set out by the FDA or other regulatory agencies in relation to Good laboratory practices, the CFR regulations such as 21 CFR Parts that apply to various industries, and also as required as part of national and global agencies; earns a good name in the market and is considered a reliable company.

 

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The increasing role of the social media in healthcare

 

The increasing role of the social media in healthcare 6With the social media having moved beyond being a platform for sharing personal information; its role in healthcare has nearly exploded of late. This is mainly because the growth of the social media has more or less coincided with that of the electronic records in healthcare.

Whatever the identifiable or unidentifiable reasons for the convergence of social media in healthcare; the fact is that social media in healthcare is a major phenomenon that is here to stay.

Social media in healthcare is being analyzed for potentially huge business opportunity, and it is being taken up for serious discussion in legal circles, with the American Congress and many other legislative bodies around the world thinking of taking serious steps for regulating it.

The increasing role of the social media in healthcare 4

The most fundamental aspect of social media in healthcare is that its growth has been helped by the core feature it brings: its ease of adaption in this sector. Healthcare information, as we all know, is very vital, and speed is of great importance. This is why social media in healthcare has come to be one of the most talked about scenarios in the healthcare today, propped in no less measure by the gigantic size of the American healthcare economy.

The advantages social media brings into healthcare

 

The increasing role of the social media in healthcare 1As just seen, the social media in healthcare facilitate great use because they help transmit information at a pace that was difficult to imagine till recently. With the development of the electronic health records (EHR) in the US, technology has made possible the customization of health records. A platform like the social media can help accelerate this pace enormously. It can also help practitioners and other stakeholders of healthcare information, such as Business Associates and Covered Entities and a host of related ones gather information and transmit it and process it at lightning speed.

Concerns

The increasing role of the social media in healthcare 3

The enormous benefits that the social media bring into healthcare notwithstanding; there is room for serious concern.

Like all other technology-driven tools, the social media in healthcare comes with an inherent risk: the laxity of records. Loose or nil security or healthcare records are a serious cause for concern. The recent breaches in health data have cost many healthcare organizations in the US millions of dollars.

The social media in healthcare give an opportunity for marketers to pitch their products or services, but they also open up lots of opportunity for the unscrupulous among these to exploit and manipulate this information. This is akin to the potential drawbacks credit cards and other such facilities bring. The social media in healthcare is a tool that is open to a high degree of vulnerability to breach. This is all the more true of new technologies, such as the cloud, which the social media in healthcare have embraced with open arms.

So, while the social media in healthcare is a force to reckon with, it is not something that is totally free of drawbacks. Till regulatory action frees the sector of these, the social media in healthcare will continue to grow, albeit with its concerns.

 

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