How creators of “true detective” would uncover the story of MS Excel sensitivity tools

Using Data Tables with one or two-inputs to deliver an array of outcomes from your model in just seconds.

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Microsoft Excel is a complete utility program, and most people who use it are aware of the many wonders it is capable of doing. Calculation, effects, drop and place and so on are some of the features that make it very efficient for users. But did you also know that it is very effective in also helping to make business forecasts?

Or, did you know that functions like Scroll Bars, Goal Seek, Data Tables, and Scenario Manager can enhance the power of your financial programs and take your ability to perform with these to exceptional heights?

You can learn all the functions of the wonderful program that MS Excel is, from a webinar that is being organized by Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, on September 19.

Miles Hutchinson, who is a highly experienced, senior Finance professional, will explain these and other functions of MS Excel at this webinar. To gain thorough knowledge of how to put this program to optimal use in helping to make forecasts and other functions, please register by visiting https://www.compliance4all.com/control/w_product/~product_id=502703LIVE

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Miles will explain the best practices for designing efficient forecasting models. He will also give a proper learning of how to apply Scroll Bars, Goal Seek, Data Tables, and Scenario Manager. All this learning, which can be had in just 90 minutes, can be applied over a lifetime.

He will cover the following areas at this session, which is aimed at the benefit of professionals who use the MS Excel program for their financial areas, such as Financial Analysts, Business Analysts, Information Reporting Officers, Tax Managers, Compliance Officers, Compliance Managers, CFO’s, Controllers, Accounting Managers, Auditors, and Risk Managers:

  • 20 rules of effective model design
  • Applying Scroll Bars to individual cells to flex them over their relative ranges with the touch of your mouse
  • Using Goal Seek to discover how much a single variable must move to reach a desired outcome
  • Using Data Tables with one or two-inputs to deliver an array of outcomes from your model in just seconds

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About the speaker: Miles Hutchinson has been an auditor with PriceWaterhouseCooper and the Chief Financial Officer of a $1 billion real estate development company. He is a highly sought after professional speaker and consultant who has presented over 1000 seminars and training sessions on a myriad of business and financial topics, such as financial analysis and modeling, accounting matters, strategic planning, and compliance with the Sarbanes-Oxley Act.

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Facts about deviation investigations everyone should know

Having a procedure on Deviation Investigations isn’t enough. it’s the content and conclusions of the investigations themselves that really count.

Focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.

One of the foremost common authority 483 and Warning Letter citations continues to be inadequate investigations. The authority uses the investigation reports and investigation trends to spot potential quality issues altogether areas of the corporate. Ultimately, inadequate investigations will result in 483 citations, Warning Letters, unharness of sub-standard product, or product recall. what is more, pricey and long system rectification is also needed.

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Having a procedure on Deviation Investigations isn’t enough. it’s the content and conclusions of the investigations themselves that really count. Doing a correct root cause analysis, gathering proof and guaranteeing a property corrective action is vital to a correct deviation investigation.

This Session can facilitate attendees perceive the elemental investigation steps and ability sets. Key focus are placed on identification and initial news of deviations, fact/evidence gathering, and incoming at the right root cause and CAPA. The importance of investigation coming up with, vital thinking skills and effective preventative action plans will be mentioned.

Who will be benefit:

  • Deviation Investigators
  • Reviewers and Approvers of Deviation Investigations
  • QA Staff and Management
  • Regulatory Affairs Staff and Management
  • QC staff and Management
  • Compliance Auditors

About the Instructor:

Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

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Implementing a Practical Technology Transfer Process

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

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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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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