Implementing a Practical Technology Transfer Process

Execution of that move is mind boggling including the connections of numerous controls over an association.

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The ideas related with actualizing a painstakingly characterized specialized and business administration programs alongside plainly characterized R&D to site move ventures for fruitful usage.

It will cover the ideas related with moving the logical innovation expected to make the item, procedures to guarantee the getting fabricating office is prepared for the item and devices and formats to help catch the information.

  • Characterize innovation move
  • Distinguish components of the business procedure structure for overseeing innovation moves
  • Distinguish New Product move process
  • Clarify advantages of innovation move
  • Decide components of an effective innovation move

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Fruitful exchange of pharmaceutical items and their procedures is basic to the effective dispatch. Its prosperity guarantees that results of the most astounding quality are conveyed to the patients alongside gathering the business requests of the organization. Anyway execution of that move is mind boggling including the connections of numerous controls over an association.

  • The importance of technology transfer

Who will get the benefit by this:

  • Senior quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Compliance Professionals
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors
  • Development Professionals
  • Senior Development Managers

About the instructor:

Steven Laurenz Chemical Engineering M.S. – Michigan State University Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization. Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortium. Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistic.

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FDA – Is Your cGMP Water System Ready for their Visit?

Documentation required to meet FDA Commissioning and Validation of Pharma Water Systems.

cGMP pharmaceutical water systems require specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation to become available for pharmaceutical manufacturing of products for sale.

Many steps and processes go into making cGMP water systems ready for their Assembly, Testing, Commissioning, Validation and Approval for cGMP use. Undoubtedly, implementing these steps properly requires previous experience and expertise in instrumentation and automation.

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A 90-minute webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how to obtain a proper pharmaceutical water systems cGMP that will help the water systems company face an FDA visit with confidence and pass its inspection.

Peter VIshton P.E., a senior an independent pharmaceutical water systems consultant who supports several companies with their water systems, will be the expert at this session. Please join the learning experience by logging on to

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At this webinar, Peter will explain what all items and procedures are required to accomplish items such as specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation, which will enable the pharmaceutical water system to be approved and placed in use. He will also familiarize participants with good practices for pharma water systems that will prevent problems.

If any of these items are missing or are not included and recorded in in GMP Water Systems Commissioning and Validation in a manner the FDA expects, it could delay its approval and use. For pharma water systems to avoid this scenario, it may sometimes become necessary to repeat the steps of the work and its documentation and adding explanations of how the work was done. All these iterations are sure to cost the organization more time and resources. Yet, the cost of noncompliance is inestimably higher than these.

At this session, the expert will show how to meet the FDA’s requirements and expectations and avoid getting penalized for noncompliance. He will cover the following areas:

  • Pharmaceutical Water Systems basics
  • Equipment that is commonly used to produce Purified Water and WFI
  • The Basic Regulatory Standards for chemistry and biological levels of Purified Water and WFI
  • The STEPS required to meet FDA Commissioning and Validation of Pharma Water Systems to assure Compliance
  • Documentation required to meet FDA Commissioning and Validation of Pharma Water Systems
  • Examples of potential PROBLEMS that can cause a System to not meet FDA Compliance
  • Dead Leg Rules
  • Compendial Action Levels of Purified Water
  • Sections of the ISPE “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems” Good Practice Guide will be referenced
  • Methods to correct Pharma Water Systems Commissioning and Validation potential problem areas
  • Good Practices for Pharma Water Systems that will prevent problems
  • Pharma Water Systems practices that the FDA expects Pharmaceutical Water Systems potential impact to Regulatory drug manufacturing

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Implementing a GxP Quality Management System-Outrageous Ideas For Your GxP Quality Management System

An unsuccessfully implemented QMS not only dwindles the organization’s resources; it could take it further away from its Quality goals.

In a scenario of competitive markets, informed customers and rapidly changing business environments, organizations are realizing that Quality and Quality Management Systems (QMS) are an indispensable tool by which they can stay ahead. This is all the more pronounced when it comes to pharmaceutical companies, since their products are delivered directly to the human body.

The benefits of a clear and effective QMS are varied. They are proven, documented and quantifiable. The most prominent benefits a successful QMS brings about are the maximization of customer satisfaction, a lowering of costs, and an increase in agility. It fortifies an organization’s quality policy, objectives and core values at every level, and integrates iterative process improvement mechanism into it. This integration engenders alignment with FDA regulations and allows the organization to optimize its product and support processes.

QMS

A GxP QMS is a process whose implementation requires the competency, commitment, coordination and confidence of all production and support staff and management. Understanding some fundamental concepts, benefits and barriers will increase the likelihood of effective GxP QMS development and deployment, compliance with quality drivers and increased customer satisfaction.

A thorough understanding of these concepts will be imparted at a valuable webinar that Compliance4All, a leading provider of professional training, is organizing on July 26. William D. Fox, a quality management professional, will be the expert at this 90-minute session, which will impart Senior Managers, Managers & Supervisors, Process Owners, Departmental Heads, QA, QC and Continuous Improvement Managers & Staff, Quality Consultants, Regulatory and Compliance Managers, and Change Control/Documentation Staff with tremendous insights into all aspects of a GxP QMS.

Please visit to enroll for this session

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For an organization to implement a QMS, all its production and support staff and management need to have competency, commitment, coordination and confidence of everyone involved in it. The deeper their grasp of a few fundamental QMS design and implementation concepts, benefits and barriers; the greater the chances of an effective deployment.

Quality Management Systems vary across and within industries and organizations. Some of the parameters that go into making each organization’s QMS unique are Quality drivers such as industry standards, regulations and best practices. Each company can use these to create a tailored design and implementation strategy that implements the organization’s specific goals, processes and customers.

QMS is such a core part of an organization’s Quality Policy that it affects every aspect of the performance. An unsuccessfully implemented QMS not only dwindles the organization’s resources; it could take it further away from its Quality goals.

At this webinar, the participants will gain solid understanding of all these aspects of a QMS, which will reap for them all the benefits it brings. William will cover the following areas at this session:

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Things You Need To Know About Cyber Security Incident Response Team Today

How to set up a foolproof and robust CSIRT that will help avert a cyberattack.

That cybersecurity is the most critical component for an organization is beyond debate. This goes without saying because attacks to any organization’s computer systems can happen at simply any time, at any location, and at any time of the day. This calls for them to be completely alert on a 24X7X365 basis.

A Cyber Security Incident Response Team (CSIRT) is indispensable for any organization, private or government, to ensure that valuable data is not breached. A system that is ready for cyberattacks 24X7 should consist primarily of a mechanism for both reporting incidents and disseminating incident-related information correctly.

A valuable webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how to set up a foolproof and robust CSIRT that will help avert a cyberattack.

At this webinar, which is being organized on July 23 and is of sixty minutes’ duration, Michael Redmond, Consultant, Speaker and Author, will be the speaker.

Please register for this webinar by visiting

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Most companies do set up a CSIRT, but one major issue with most of them is that the teams are not adequately trained to handle and test all aspects of the security issues. Both testing and training are necessary to create awareness among the teams, which will help them to respond to an attack or a potential one better. Both reporting incidents and disseminating incident-related information correctly is a must.

Personnel connected with cybersecurity, such as CISO, CSIO, CEO, Risk Managers and Auditors will gain enormous learning from this session, which will cover the following areas:

  • How often to test
  • Types of testing
  • Who should be involved
  • Scenario Development
  • Organizational process

About the speaker: Michael is the Chapter President for Association of Contingency Planners Eastern Great Lake Chapter and an active member of ISSA. She has consulted in the area of Cyber Security for clients in the arenas of Healthcare, Insurance, Financial and Manufacturing. She has been selected to speak on Cyber Security Incident Response and SIEM at various conferences.

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How to Deal With Bad Results Under GLP

A bad GLP result can be due to many factors. The main symptom of a GLP noncompliance event is a result outside is +/- 3sigma. To avoid this, it is necessary to carry out a root cause failure/analysis.

How do laboratory personnel do this to reverse a bad GLP result? What are the steps to this? Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is going to explain these at a webinar it is organizing on July 22.

John Fetzer, a senior HPLC professional, will offer learning at this webinar on both the in-laboratory and outside of it, to help secure a positive GLP result. Please enroll for this valuable sixty-minute session by visiting.

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An in-lab step for resolving a noncompliant GLP result is for both the laboratory personnel and management to immediately carry out an internal review of the specific conditions for the bad result. The actions they have to take include:

Scientists analyzing chemical substances for a new research in laboratory.

  • Checking control charts to see if trends in performance occurred
  • Examining all logbooks and recordkeeping related to that analysis
  • Making an initial report available to the lab manager
  • Stopping all regular operation of that method and informing customers about the same.

As far as the outside of laboratory measures are concerned, labs should:

  • Set up root cause teams to examine the preliminary assessment as well as control charts and other operational data to see if they can locate a clear cause
  • Compare the timing of the non-compliance to these records
  • Carry out a closure by issuing a root-cause report with the necessary corrective actions
  • Carry out a revalidation
  • Inform customers of these actions taken.

At this webinar, which will be of immense value to Analysts, Lab Supervisors and Managers, QA, Managers and Personnel, Consultants, Validation Specialists and Chemists; John will show how these steps can be carried out.

He will also explain how blunders and the possibility of outliers can also contribute to a noncompliant result and highlight the importance of outlier testing. He will cover the following areas at this webinar.

https://t2m.io/pjxKHCzY

Unconventional Knowledge About Buying Or Selling A Business That You Can’t Learn From Books

Depending on who you are in the deal, you should be ready to negotiate, to do which you have to possess very sharp bargaining skills. Not all of these are taught in books.

Buying or selling a business is not the same as doing the same with consumer items. It requires a lot of thought and insight, and having to answer many questions about the business. The impact the merger or acquisition transaction has on the end result should be examined very carefully and critically. For instance, both the value of the business and the ROI will get impacted differently based on the whether the manner in which the transaction is recorded: as an investment or as an expense.

This is just one of the many aspects that need careful consideration when buying or selling a business. Although a lot can be learnt from books, conventional and grassroots wisdom is handier when it comes to handling these issues of high magnitude. Depending on who you are in the deal, you should be ready to negotiate, to do which you have to possess very sharp bargaining skills. Not all of these are taught in books.

A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show what skills need to be honed when it comes to buying or selling a business. The expert at this webinar, which is being organized on July 18, is Bart Basi, a highly experienced financial expert and academic. Please join us for this lively and meaningful session, which could go a long way in deciding the success of your business purchase, by registering at Unconventional Knowledge

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Dr. Basi will explain the financial. legal and tax implications of buying or selling a business. He will describe what ramifications need to be considered when allocating the resources of the transaction. This is all the more necessary and important to understand, as US tax code requires the parties to agree on what is being sold and what is being purchased, and determines the taxes paid by the seller based on the allocation agreed between the parties. This is just one of the many aspects of a business merger or acquisition transaction, whose knowledge can go a long way in ensuring that the financial, legal and tax elements of buying or selling a business are considered and complied with.

Both the parties need to also be aware of the consequences of the transaction. These could vary very highly based on whether the transaction is structured as an asset, stock, or a redemption transaction.

Dr. Basi will present actual cases to help the participants of this webinar get an understanding of the concepts. He will also describe the various issues facing both the buyer and the seller and explain the specific options available to each in a transaction under different situations.

At this session, Dr. Basi will cover the following areas:

  • Asset Transactions
  • Stock Transactions
  • Stock Redemptions
  • Stock Redemption Attribution Rules
  • Overview of IRC section 1202
  • Opportunity Zone Investments
  • IRC section 338(h) (10) election
  • Tax-free Reorganization
  • IRC section 1031 Exchanges
  • Personal Goodwill
  • Buy/Sell Agreements
  • Trusts

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About the expert: Dr. Basi’s expertise spans almost all areas of finance, such as financial accounting, business succession, business valuation, mergers and acquisitions, retirement and estate planning, strategic planning, and tax aspects of business decisions for closely held and family businesses.

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The Next 7 Things To Immediately Do About Excel Data Visualization

Data visualization is the representation of numerical data in a visual format so that your audience can quickly and easily understand it and gain insight from it.

In this session, participants will learn how to visually represent your data using both traditional charts (bar charts, line charts etc.) as well as how to do the same using some of Excel’s non-charting tools.

Until a few years ago it was enough to take a set of numbers and create a bar chart or pie chart. Although in the right situation these traditional charts are still appropriate, things have moved on and we’re constantly hearing words like Data Visualization and Infographic.

It’s time to get your Excel-related business and communication skills up to date and learn how to use it to present data in the modern world. Data visualization is the representation of numerical data in a visual format so that your audience can quickly and easily understand it and gain insight from it.

Areas covered by the instructor

  • Charting 101 – create a basic chart
  • From drab to fab – enhance and customize a basic chart
  • Combination charts – line and bar in a single chart
  • Dynamic charts – automate adding new data to a chart
  • Creating in-cell Sparkline charts
  • Creating infographics with Excel
  • Using Conditional Formatting to present data visually
  • 3D Map – presenting geographic data in a visual way
  • An introduction to the Power View add-in

Important Learning Objectives you have to learn :

  • Learn how to select the most appropriate chart to convey your message
  • Learn how to create a chart from a set of data and change its appearance
  • Learn how to create Sparkline charts (really useful in dashboards)
  • Learn how to create infographic-style charts
  • Learn how to represent data in a visual way without using the charting tools

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