Want An Easy Fix For Your Good Laboratory Practices? Read This!

This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

GLPs are enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

What are the Learning Objectives:

  • What are Good Laboratory Practices
  • Why were they created
  • What is the objective of GLPs and how are they associated with GMPs and SOPs
  • Statistical procedures for data evaluation
  • Instrumentation validation
  • Analytical and laboratory certification
  • Documentation and maintenance of records
  • Consequences of noncompliance
  • Disqualification and reinstatement

Who will Benefit:

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Research and Development Personnel
  • Regulatory Affairs Personnel
  • Project Managers
  • Manufacturing Managers
  • Validation Engineers
  • Internal Auditing Personnel
  • Microbiology Personnel
  • Auditors

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How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Course “How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
  • 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.
  • 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.
  • This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Course Objectives:

  • 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

    Day 1 Schedule


    Day 1 (8am to 5pm; 0.5 registration, 1.0 lunch, 0.5 (2-15min) breaks, 7.0 class = 9.0)
    8:00am to 8:30am registration
    8:30am class starts


    Lecture 1:
    Introduction to the FDA (1:30) {1:30}

    • How the regulations help your company to be successful
    • Which data and systems are subject to Part 11

    Lecture 2:
    21 CFR Part 11/Annex 11 – Compliance for Electronic Records and Signatures (4:00) {5:30}

    • 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

    Lecture 3:
    The Five Keys to COTS Computer System Validation (0:30) {6:30}

    • The Who, What, Where, When, and Why of CSV

    Lecture 4:
    The Validation Team (0:30) {7:00}

    • How to select team members
    • How to facilitate a validation project

    Day 2 Schedule


    Day 2 (9am to 3:30pm; 1.0 lunch, 0.5 (2-15min) breaks, 5.00 class = 6.5)


    Lecture 5:
    Ten-Step Process for COTS Risk-Based Computer System Validation (1:00) {1:00}

    • Learn which documents the FDA expects to audit.
    • How to use the risk-based validation approach to lower costs.
    • How to link requirements, specifications, risk management, and testing.
    • Document a computer system validation project using easy to understand fill-in-the-blank templates.
    • Based on: “Risk-Based Software Validation – Ten Easy Steps” (Davis Horwood International and PDA – http://www.pda.org, 2006).

    Lecture 6:
    How to Write Requirements and Specifications (0:30) {1:30}

    • Workshop for writing requirements and then expanding them for specifications

    Lecture 7:
    How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:00}

    • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

    Lecture 8:
    Software Testing (1:00) {3:00}

    • Reduce testing by writing test cases that trace to elements of risk management.
    • How to write efficient test cases

    Lecture 9:
    System Change Control (0:30) {3:30}

    • How to manage a validated system with minimal documentation

    Lecture 10:
    Purchasing COTS Software (0:30) {4:00}

    • How to purchase COTS software and evaluate software vendors.

    Lecture 11:
    Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}

    • How to save money
    • How to increase quality
    • How to increase compliance with less documentation

      Carolyn Troiano

      Consultant, BrainStorm Central Consulting

      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…

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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Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA’s realization, over time and experience; that the major part of a device’s problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

cgmpForCombinationProducts

Outstanding characteristics of the Design History File

cgmpForCombinationProducts

What should the Design History File contain?

The DHF should contain the following:

cgmpForCombinationProducts

Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU’s version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company’s “Declaration of Conformity” for that product:

  • General Information/Product Description/EC Authorized Representative
  • Classification Determination
  • Essential Requirements
  • Risk Analysis
  • Labeling
  • Product Specifications
  • Design Control
  • Clinical Evaluation
  • System Test Reports
  • Functional Bench Testing
  • Lab Testing
  • Sterilization validation (or AAMI TIR 28 Analysis)
  • Packaging Qualifications
  • Manufacturing
  • Sterilization
  • Conclusion
  • Declaration of Conformity
  • Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices

While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

 

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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

What are the potential areas of risk management?

 

What are the potential areas of risk management.jpgThe most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.

In a very broad sense, the potential areas of risk management include all areas of a business, because simply no area of the business is exempt from a risk. Talk about finance, and it comes with a risk. What about manufacturing? And what about operations or marketing? How about human resources? In this very expansive sense, every area or activity of the business is among the potential areas of risk management.

Potential areas of risk management could lie simply anywhere

potential-areas-of-risk-managementOn top of these potential areas of risk management that each part of the business is prone to; there are also the other industry-related risks that inhere into any business. The risks of running, say, a firecracker business, are much higher than running a grocery store. So, potential areas of risk management should ideally include a very broad discussion on every aspect of risk management.

However, when one takes an overview of the potential areas of risk management instead of trying to break down the elements of each function in which there are potential areas of risk management; one can classify these among them:

Generic risks: As we have been discussing, any business, absolutely any business, comes with some degree of risk. And, each business comes with its own generic risk, such as falling short of funding at crunch times, core people leaving the organization at important times, logistics failures at critical times, and so on.

potential-areas-of-risk-managementProduct specific risks: As the title suggests, this kind of risk is specific to the product that the business deals with. Some products come with their unique risks, and hence, this kind of risk counts among the potential areas of risk management.

People-specific risks: These can happen in a business in which much depends on a few important people. The inefficiency or departure of such people could be among the potential areas of risk management for businesses or projects that are dependent on people.

potential-areas-of-risk-managementFinancial risks: Obviously among the top potential areas of risk management; financial risks come into play when the organization is not able to meet its bottom lines due to a variety of factors. Not getting funds on time, not getting payments from customers on time, not being able to service debts are some of the factors of financial risks.

Technology risks: Technology is a high area of risk, because it keeps changing at a breakneck speed. If organizations don’t keep up with the pace, technology risks could count among potential areas of risk management.

potential-areas-of-risk-managementMarket risks: Market risks are yet another of the potential areas of risk management because most businesses are run on the assumption or speculation that a market is going to grow at a certain rate or pace. If the estimate of this market goes wrong, it affects the business negatively.

Customer risks: The ultimate decider of the business is the customer. If a customer gets irate at a bad product or service and issues bad press, it could become one of the biggest of the potential areas of risk management.

potential-areas-of-risk-managementReal estate risks: For some businesses, especially retail, the location of the business is a major factor. In many instances, the choice of location could often decide the fate of the business. Imagine setting up a high end retail store in the vicinity of a slum. Does that make sense? Yet, even if a business chooses the right location, it could sometimes be forced to relocate due to factors such as legal issues of the property, making this among the potential areas of risk management.

Finally, what needs to be said is that the list above is by no means a comprehensive one. The potential areas of risk management, as we have discussed at the beginning, are simply too many and too fluid and subjective. They could vary from market to market, product to product and business to business. A business that is perceptive about the market has to make the right assessment of the potential areas of risk management before it starts one. It should also be ready to face the potential areas of risk management if it is up against any factor that lies beyond its reach or forecast.

 

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Medicaid platinum, silver for the rest

AR-170829285
Insurance Commissioner Roger Sevigny … Findings of report are “not conclusive.”

CONCORD — The path New Hampshire has taken toward expanding Medicaid is pushing prices up for everyone else who buys health insurance on the Obamacare exchange at healthcare.gov, according to an analysis recently completed for the Insurance Department.

The average medical costs for the newly insured Medicaid patients are 26 percent higher than the non-Medicaid population on the exchange, even though the Medicaid patients are on average younger.

That is in large part because Medicaid patients are getting platinum plans that they use more aggressively because they have no co-pays or deductibles, while those paying some or all of their policy premiums are mostly in silver plans that they use more judiciously, according to the actuarial firm conducting the analysis.

“Generally, when populations are enrolled in plan offerings with low member cost-sharing, utilization of services is greater,” according to the actuaries from Gorman Actuarial who wrote the report. “This is referred to as induced demand.”

Gorman found that the presence of the expanded Medicaid population in the individual market raised average claim costs for the entire market by 14 percent.

The findings, based on 2016 claims data, were presented Monday to a legislative commission studying the future of expanded Medicaid in New Hampshire, which, in its current form, expires at the end of 2018.

One goal of Obamacare was to get more people covered, and part of the strategy was to make it easier to qualify for Medicaid, so-called “expanded Medicaid,” with the federal government paying 100 percent of the additional cost through 2016. Starting in 2017, the match declines slightly each year until it reaches 90 percent in 2020 and remains there, assuming the law is not changed or repealed.

Using the private market

Nineteen states, mostly in the South and Midwest, decided not to expand Medicaid, while New Hampshire was among 31 states and the District of Columbia that added to their Medicaid rolls. New Hampshire and Arkansas decided to use the private insurance market to cover the newly insured.

To qualify for traditional Medicaid in New Hampshire, you had to have low income as measured by federal poverty levels, and have an additional qualifying condition, such as being a parent or caretaker, disabled or pregnant.

The analysis can be viewed below:

With expanded Medicaid, unmarried, childless, able-bodied adults earning up to 138 percent of the federal poverty level could qualify, and in New Hampshire 40,000 took advantage of the opportunity.

But New Hampshire did not put those 40,000 new enrollees into the same traditional Medicaid program that was already serving 100,000 residents through managed care organizations that control costs. Instead, they obtained coverage from one of the companies offering plans on healthcare.gov, mostly the Ambetter plans offered by New Hampshire Healthy Families.

When the program was being designed that way, ostensibly to leverage the private sector instead of growing a government program, conservative groups like Americans for Prosperity warned against blending the new Medicaid customers whose costs are fully covered with customers who face co-pays and deductibles.

“Expanding Medicaid at all was a bad idea,” says Greg Moore, state director with Americans for Prosperity. “Expanding Medicaid in the individual marketplace was a disastrous one, and now we are asking people who are forced to buy health insurance under the Affordable Care Act to subsidize this bad decision.”

Proponents of expanded Medicaid, including the state’s hospitals, health care providers and many in the addiction treatment and recovery community, say the expansion has been an overall plus to the state, particularly in getting insurance for people in need of addiction-related services.

Facing a decision

So the state has to decide what to do about the program, as it sunsets in its current form in a little more than a year. Insurance Commissioner Roger Sevigny said the findings in the Gorman analysis are “not conclusive” on whether expanded Medicaid should continue in its current form in New Hampshire.

“How to best cover this population is a complex question that the New Hampshire Legislature will wrestle with in 2018,” he said. “These are times of unprecedented uncertainty for individual markets in New Hampshire and across the country ­— a factor that compounds the difficulty of the reauthorization question.”

Most New Hampshire residents who have health insurance obtain it through their employer in a group plan. But the state has about 90,000 individuals who buy insurance on the individual market, via healthcare.gov.

Of that 90,000, almost half (40,000) consist of the fully covered, expanded Medicaid population. The other half, about 50,000, consist of individuals who purchased policies on the exchange, many with premium subsidies.

The big question

One of the big questions the state has to face, if it keeps expanded Medicaid at all, is whether or not to keep the newly eligible population in the individual market or put it under traditional Medicaid.

Tyler Brannen, health care policy analyst in the Insurance Department, says the choice is not that obvious. Leaving the Medicaid population with the paying customers increases costs, but losing nearly half the risk pool in the online exchange would come with consequences of its own.

“They have increased claims cost,” says Brannen of the new Medicaid patients, “but in the future, they may be the ones who provide some stability because they may not be the people dropping out because of price increases.”

dsolomon@unionleader.com