Use OneNote to manage your meetings

Microsoft OneNote is a program that works as a digital notebook. It saves users the trouble of having to scramble for a piece of paper whenever they feel like scribbling some information or idea down. Moreover, it saves the user the trouble of having to preserve a piece of paper on which the info is jotted down.

Microsoft OneNote helps users to type, write or draw on the digital notebook while continuing to have the same feel as a regular paper and pen. It is designed to help people have access to note down ideas or important information with the ease of a notebook. Users can also search the web and clip pictures to the text to enhance the effect. Several other features are available to add effect to the text.

Another feature of the Microsoft OneNote program is that the documents can be shared across the www. It helps to communicate ideas, thoughts and occasions across devices. It is available for a number of devices ranging from Apple to Windows and Android and the web.

Explore the ins and outs of Microsoft OneNote

There is a lot to explore in this program. This is what a learning session from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering at a webinar. The speaker at this webinar, Mike Thomas, has worked in the IT training business since 1989. He is a subject matter expert in a range of technologies including Microsoft Office and Apple Mac. He has produced nearly 200 written and video-based Excel tutorials. It is this rich experience that will be in full display at this webinar.

To learn the nitty-gritty of all the functions that you can get Microsoft OneNote to perform for your benefit, just enroll for this webinar by visiting Best practice for creating a Notebook

Business Professionals, Business Owners, Researchers, Administration Support Staff, Educators, for that matter anyone who wants to learn how to get the best from OneNote to manage projects and their life, will gain from this session.

Putting the program to maximum use

Mike will explain how to use OneNote notes thoroughly for storing text, images, videos, embedded files and drawings and sketches. He will show how to optimize OneNote notebooks for sharing with colleagues and customers and using it for thorough collaboration at work. The ways by which OneNote can be used to manage projects, meetings, and life itself will be taught at this session.

Mike will cover the following areas at this webinar:

o  Best practice for creating a Notebook

o  Restructuring and rearranging a Notebook

o  Protecting your information

o  Using OneNote for Internet research

o  Collaborating with others / Sharing a Notebook

o  Drawing, sketching and hand-writing notes

o  Searching OneNote

o  Integrating OneNote with Outlook

o  Go Mobile: How to use OneNote on an iPad.

Paper records to electronic for pharmaceutical companies

Following the rapid advances being made in the field of information management in the past quarter of a century or so, computers have increasingly come to replace paper as the source in which important documents are created and stored. Till the last decade of the previous century, organizations used paper to record and document information relating to their research, development and business. From around the start of the 1990’s; the shift towards computerization of paper records has been noticeable.

Many differences between paper and electronic records

One of the defining differences between this electronic standard and traditional paper records is that while the latter used to be stored in a central, protected environment and managed by a designated managers; electronic records are spread over many locations.

Although some are managed by a central authority; most are under the control of individuals. Individuals in charge of this work have a wide range of computer based devices such as phones, laptops, tablets and USB storage devices at their disposal, which can be used for functions such as authoring, storing, and copying and transmitting relevant information.

Also, the information available on these systems can be stored and shared within several locations on the web, with the option of protecting some better than others. What has also changed substantially is the process of verifying the authenticity of a record. Earlier, the method used to authenticate paper records was via inked signatures of the author and witness. Encrypted e-signatures are replacing this practice.

Submissions to the regulatory authorities

In line with this development, the FDA and other global regulatory agencies started accepting electronic files, or at least parts of submissions, for testing and marketing drugs. This movement, which started in the early 1990’s, led to the creation of the Common Technical Document (eCTD) standard. This standard is now required in the US and most countries around the world.

If pharmaceutical and life sciences companies have to submit documents such as the NDA, ANDA, IND, BLA, DMF and the BMF to the FDA electronically, the eCTD has been the pan-industry, widely accepted standard since 2008. Submissions are, in fact, no longer done via paper records. If companies have to incorporate legacy paper records into an eCTD; they have to scan those and put them into a text readable format.

A source of important information

Despite the existence of this method; many companies continue to possess huge troves of paper based information, which are yet to enter the cyber realm. These records contain important information relating to the pre-clinical, clinical and drug safety paper records of drugs that did not make it to the marketing stage for a variety of reasons, because of which these companies have archived this information.

This archived data, if harnessed effectively, could be a rich source for offering knowledge that will go on to enhance inputs for submissions for other new or emerging indications for the drug or support efficacy or safety for related drugs. Many organizations have a large collection of paper records with retention times of 50 years or more. There is a dilemma of how to best preserve and utilize these records.

What is the way of going about for transiting?

Many companies are in a quandary about what to do in a situation in which the majority of records are electronic, but a substantial number remain as aging paper records. If the wealth of information available in paper format is to be exploited meaningfully, should they convert all the paper records to an electronic format, convert some of them, or just leave them in their current form? Given that complete conversion and subsequent integration is a very expensive and laborious exercise; a better option will be to convert on an as-needed basis.

The ways of how to do this effectively will be the topic of a highly educative webinar from Compliance4All, a provider of professional trainings for all the areas of regulatory compliance. At this webinar, Dr. Charlie Sodano, an experienced, globally recognized information management professional who launched eOrganizedWorld a consulting firm specializing in the planning and implementation of records and information management systems, will be the speaker.

To understand and have these issues resolved from the expert, please register for this webinar by logging on to Records policy and procedures

Dr. Sodano will take up and explain the issues relating to conversion of paper records into electronic, and the ways in which the submissions need to be made. This training is of importance to professionals in Research & Development, Regulatory, Clinical, Legal, Information Technology and Validation.

During the course of this session, Dr. Sodano will cover the following areas:

o  Records policy and procedures

o  Records data map

o  Incorporating paper records into a eCTD

o  Converting paper documents into a useful electronic format

o  Scanning costs and resources

o  Indexing and organizing scanned records and integrating them

o  Long term record storage and retrieval.

How does the FDA scrutinize Promotion?

The FDA has strict requirements on the way promotion and advertising practices are to be implemented by the industries that it regulates. Section 906 of the Food and Drug Administration Amendments Act (FDAAA), which came into effect in 2008 and amended the section that pertained to this topic previously, namely Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA); now requires that published Direct to Consumer (DTC) advertisements for prescription drugs should include the following statement printed conspicuously for all products including vaccines:

“You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.”

One of many requirements

This is just one of the many requirements from the FDA about promotion and advertising practices. Any individual or company holding an approved application for a drug will be panelized for making a false or misleading claim in a Direct to Consumer (DTC) advertisement about the pharmaceutical product.

Such an entity can be fined up to a quarter of a million dollars for the first such violation in any three-year period. This fine can go up to half a million dollars for each subsequent violation in any three-year period. Further, the FDAAA fixes different levels of penalties for biological products.

New requirements that reinforce existing ones

In addition, the FDA issued two Draft Guidance documents in January 2017. These concern communications made by device manufacturers about information that is contained in the labeling of these products. The nub of these Guidance Documents is that for FDA-regulated medical device companies to escape enforcement actions from the regulatory agency; labeling has to be consistent with the standards and expectations set out by the FDA. It lists out a number of factors the FDA takes into consideration to determine if the labeling meets the standards of consistency set out by it. These are some of them:

o  Indication

o  Patient Population

o  Limitations and Directions for Handling, Preparing, and/or Using the product

o  The recommended dosage or use regimen or route of administration

o  The potential for increasing harm

o  Safe and effective use.

The FDA has, in this communication also set out the factors that it does not consider as being in line with its idea of consistency in labeling and false claims:

o  Stage, severity, or manifestation of disease

o  Use alone versus in combination with other product(s)

o  Route of administration

o  Strength, dosage, or use regimen

o  Dosage form.

This makes the grasp and proper implementation of the FDAAA requirements absolutely essential if an organization in the FDA-regulated industries has to be free of enforcement actions from the FDA and subsequent penalties.

Learning session on how to get the dynamics of FDA scrutiny of promotion and advertising practices right

This is the important learning a webinar from Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Casper Uldriks, who through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He brings the experience of having specialized in the FDA’s medical device program as a field investigator, a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. To gain understanding and clarity on these areas of FDA scrutiny of promotion and advertising practices, enroll for this webinar by logging on to FDA Scrutinize Promotion and Advertising Practices

Anticipate the FDA’s viewpoint of consistency

Anticipating the way the FDA will view and interpret its advertising and the way it monitors this activity is critical for any company that makes a marketing launch. If it fails to do this right, it could land itself in trouble and invite expensive and reputation-damaging enforcement actions. Companies that come under FDA regulation need to have a perfect grasp of what they are doing with DTC advertising and should not leave anything to chance.

Companies have to keep up with the defined boundaries of DTC advertising and promotion if they have to avoid FDA scrutiny. If the FDA deems a DTC marketing campaign to be misbranding the product, it will not allow it to be marketed. This calls for more sophistication and novelty on the part of firms in their advertising methods and messages. Firms need to pay attention to all the components of their advertising in mass media, such as volume, images, the prominence and conspicuousness of information, the speed of the message, subliminal messaging and the core message.

Get all the factors right to avoid FDA enforcement

This calls for a proper understanding of what each component of the advertising attempts to accomplish and then evaluate the integrated message. Ironically, this range of factors arms the FDA with sufficient ammunition to determine the advertising as misbranding and term it illegal.  The speaker will suggest the ways of tackling issues like this.

Casper will talk about these issues in depth at this webinar. He will cover the following areas:

o  FDA’s approach to DTC advertising and promotion principles

o  FDA guidance and use of cognitive psychology

o  Types of violation for illegal DTC advertising practices

o  The role of sales and marketing departments

o  Executives’ legal liability.

How to implement technology transfer in pharmaceuticals

Technology transfer is a process that has gained widespread acceptance and prominence in many areas of knowledge all over the world today. Technology transfer can be broadly defined as the way in which technology is transferred from the source of its origin of creation to sources from where it can be developed and/or distributed to a wider area.

Technology transfer is carried out in a number of areas. In universities, which are breeding grounds for new ideas, technology transfer is carried out to help the product reach out to the market. In the field of intellectual property (IP), technology transfer is the means by which a patent or a copyright or a trade secret is licensed to be exploited for commercialization.

In pharmaceuticals

Technology transfer is a major component in the field of pharmaceuticals, as well. In the field of pharmaceuticals, the method by which technology transfer is done is important. Correctly describing the methods and processes of technology transfer is extremely important to prevent any major deviations or misunderstandings between the parties at a later date. The aim of exploitation of technology, patent-protected or otherwise, in this field is to help the product reach out to the larger market, so that the general public benefits from the invention or innovation. Defining the terms by which the commercial gains of the technology transfer will be shared is also important.

If a pharma product is to become successful; its transfer and that of its processes has to be handled extremely well for the product to enjoy a successful launch. Only this ensures that pharmaceutical products of the highest quality are delivered to the patients, and also that they meet the expected business goals.

Yet, executing the technology transfer is complex even in these days of legal protection for IP. Technological transfer of pharma products involves the interactions of many disciplines across an organization. While carefully developing, managing, and transferring of technical and business knowledge is one aspect; the development of processes and steps for defining the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems is another.

A learning session on pharmaceutical technology transfer

The ways of handling this whole process of technology transfer in the field of pharmaceuticals will be the teaching a webinar from Compliance4All, a leading provider of professional trainings in all the areas of regulatory compliance will be organizing.

The speaker at this webinar is Steven Laurenz, a senior pharma professional who brings over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization.

To enroll for this webinar and gain the benefit of hearing from this seasoned professional, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501257LIVE?Wordpress-SEO

The technology transfer process

The aim of this session is to introduce the concepts associated with implementing a carefully defined technical and business governance program. Along with this, Steven will also suggest a clearly defined R&D process to chart technology transfer steps for successful implementation. The concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge, will all be covered at this webinar.

These are the objectives that this webinar will help the participants achieve:

o  Define technology transfer

o  Identify elements of the business process framework for managing technology transfers

o  Identify New Product transfer process

o  Explain benefits of technology transfer

o  Determine elements of a successful technology transfer

Steven will cover the following areas at this webinar:

o  The importance of technology transfer

o  The use of a technical review system to update and review technology knowledge obtained during drug product development

o  The use of a Product Strategy Review system to review important business aspects in preparation for transfer

o  Tools and Templates used for technology transfer.

Cash management in ERP systems and Reconciling bank statements

Cash management is a major component in ERP systems such as Oracle. It is a module that offers information about the most critical component of the business, namely cash flow. Cash management processes and analyzes all of the business’ cash and bank transactions from a number of sources such as:

o  The payments made to a supplier as reflected in the invoices

o  The value of receipts got from the business’ sales invoices

o  Single or isolated payments not from any of these above categories

Another important role performed by the cash management module is that using it, the organization’s Finance personnel can analyze financial transactions of all kinds that happened during a selected period of time. Cash management in ERP also gives Finance the inputs that help them understand where the funds are coming in from, and how they need to be allocated and spent so that the company meets its payments-related obligations.

Functionality of Cash Management module

Usually, cash management modules in ERP systems are built to accommodate the following features:

o  Tracking Supplier Payment

o  Tracking the way in which sales invoice amounts receipts are made

o  Helping to forecast the cash flow

A learning session on cash management and bank statement set up and reconciliation

Do all these aspects of cash management sound confusing? It is to address these confusions and issues related to cash management that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar.

Kevin Chenoweth, who has wide-ranging expertise in designing project plans for multi-million dollar Oracle R12 financial leading to under budget and on-schedule projects and has helped organizations complete full life-cycle implementations in the Oracle financials modules through effective leadership, will be the speaker at this webinar.

To hear Kevin offer his insights into cash management, which is a result of his having implemented Cash Management processes for both technology and manufacturing SMB and Fortune 500 companies such as Comcast and having addressed their particular challenges in streamlining their bank account structures and relationships to align them with their changing business structure and accounting systems; just enroll for this webinar by logging on to   http://www.compliance4all.com/control/w_product/~product_id=501331LIVE?Wordpress-SEO

The wealth of the speaker’s experience

During this course, Kevin will offer guidance and understanding about the fundamentals of Cash Management in ERP systems such as Oracle. Another important related activity, namely bank statement formats, will also be discussed, along with how to and when to apply them.

Kevin will discuss all the challenges associated with bank statement set up and reconciliation, namely how to handle various deposits in transit, outstanding checks, service charges, and non-sufficient fees. During this explanation, he will illustrate the experiences he had earlier in his career at organizations such as ComCast, where he helped prepare its merger with Time Warner with important works like streamlining its zero-balance accounts and regional banks.

Kevin will cover the following areas at this session:

o  Bank reconciliations for various types of transactions

o  Streamlining of accounts to match company strategy

o  Consolidation of accounts to match company strategy

o  Preparation of banking relationships for a merger

o  Zero Balance accounts and how to manage them

o  Understanding of cash flows in strategic initiatives

o  How cash flows interact with financial statements

http://www.managementstudyguide.com/cash-management-module-erp.htm

All about human error and ways of reducing it

There is the saying that after all is said and done, to err is human. In a philosophical sense, it can have numerous interpretations, but in the field of Good Manufacturing Practice, it cannot be taken with a pinch of fatalism. GMP requires everything to be precise and scientific to a T. GMP is not an area that leaves anything to human error. Being an area of science, GMP has no place for imagination and chance.

This is why human errors should be taken note of very seriously when it comes to GMP. Human error is seen as a major cause of most losses caused to many organizations. Whether these human errors are intended or not is a matter worth debating on another occasion. But for the purpose of this discussion, quality is something that can severely get dented with human error.

Human error is known to be the culprit and the cause of many losses relating to quality and production. It is at the root of many performance issues. It is highly unlikely that even with our use of many precise scientific tools and devices, human error will totally be eliminated. It is accepted that human error can only be mitigated and minimized.

Understand the source first

So, if human error is something that is known to be part of our lives, it is worth exploring what needs to be done to contain it. The first step is to identify the source of human error. Human error starts right at the design stage. The prudent approach is to thoroughly understand the root cause and reduce the likelihood of human error by going deep into the variables and causes that bring about human error.

This involves having to manipulate the procedures, training, and workplace environment where many variables that affect human behavior intersect. In order to understand the cause and nature of human error, one needs to directly address the systemic weaknesses in order to improve or fix them. To do this, it is necessary to get an understanding of human behavior and the psychology of error.

Get professional trainings to explore human error in depth

Want to understand how to reduce and keep down human error in quality and production? Then, a webinar from Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance is what you need. This webinar is being organized to help regulatory and quality professionals get a thorough feel of the factors that cause human error.

Ginette Collazo, a human error and human behavior expert who has spent more than 15 years in technical training, organizational development and human reliability areas, will be the speaker at this webinar.

 

 

 

Just visit http://www.compliance4all.com/control/w_product/~product_id=501286LIVE?Linkedin-SEO to register for this highly interesting and valuable webinar.

Practical approaches to all areas of human error

Ginette will offer practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology for the correction and prevention of these issues and to help avoid their recurrence.

This webinar will cover all the important areas of human error. The speaker will help the participants understand the factors and causes of human error. She will help them explore the importance of human error from the regulatory and business perspectives. She will define the process of managing human error deviations.

Another important learning objective of this webinar is human error measurement and the tools for measurement. Ginette will also help the participants to establish Key Performance Indicators and help them understand how to define and measure human error rate, cognitive load, and CAPA effectiveness. She will also help them identify what they can do in their personal capacities to support human reliability.

FDA’s thinking behind 21 CFR Part 11 inspections

21 CFR Part 11 is an FDA regulation that deals with electronic records and electronic signatures. 21 CFR Part 11 has a set of FDA regulations that define the various parameters that need to go into electronic records and electronic signatures for them to be considered genuine, that is, for these records to have the same trustworthiness, reliability and equivalency as those of paper records.

Any organization has to comply with the requirements set out in 21 CFR Part 11 to ensure that they can be considered as being equivalent to paper records and handwritten signatures.

The following come under the purview of Part 11:

o  Biologics developers

o  Biotech companies

o  CROs

o  Drug makers

o  Medical device manufacturers

o  Other FDA-regulated industries, with some specific exceptions

In other words, the provisions of 21 CFR Part 11 apply to organizations the life sciences industry. The provisions of 21 CFR Part 11 apply to areas that come under FDA regulated areas of research, such as researching, carrying out clinical studies, manufacturing, distributing and maintaining products.

The FDA has spelt out its best practices guidelines with regards to 21 CFR Part 11. These cover the following areas:

–       The Standard Operating Procedures (SOPs) and controls that go into supporting electronic records and signatures, which include measures such as, but are not limited to security, Computer System Validation and data backup

–       The steps taken for ensuring the security of the computer system have audit trails for creating and tracking data values, which make electronic signatures reliable and trustworthy

–       Steps to show proof that the system works according to what it is intended to, for which validation and documentation should be offered. Into this, the feature of helping users determine when a system is not working as it is intended to is also built in.

Punitive actions from the FDA on the rise

Experience has shown that 21 CFR Part 11 is an area in which the FDA has seen a high number of citations and other punitive actions. In only the last three years, the FDA issued no fewer than 30 Warning Letters that saw Part 11 violations. These actions have concerned not only the core areas of 21 CFR Part 11, namely integrity, availability and security of data; but also to validation of software and computer systems.

These findings are the result of the FDA’s renewed efforts at inspection and enforcement of Part 11 requirements. What makes these facts about the FDA actions intriguing is that for most part, these citations are against the Predicate Rules, rather than against Part 11 per se. All this lends credibility to the belief that there is widespread confusion about what the FDA is actually looking for in its inspections.

A useful learning session on Part 11 compliance

If companies in the life sciences industry, who are subject to Part 11 inspections, have to avoid these citations from the FDA; they need to first of all get a clear idea of what 21 CFR means and the reason and the manner in which it is being implemented. They next need to understand the enforcement part of Part 11 inspections from the FDA’s perspective. A grasp of these matters will help them prepare their company for Part 11 inspections.

The ways of getting these aspects right constitute the core of learning session from Compliance4All, a highly popular and renowned provider of professional trainings for all the areas of regulatory compliance. At this webinar, Angela Bazigos, a highly experienced regulatory compliance professional who brings over four decades in the industry, will be the speaker.

To steer clear of the entire muddle behind the Part 11 compliance, just enroll for this webinar by visiting      http://www.compliance4all.com/control/w_product/~product_id=501346?Wordpress-SEO

In the process of giving a clear understanding of how to implement the provisions of 21 CFR Part 11 in a way that avoids actions from the FDA; Angela will be covering the following areas at this webinar:

  • 21 CFR 11 then and now: a brief history of 21 CFR 11 and what it looks like today
  • Part 11 Basics
  • FDA’s view of 21 CFR 11 Compliance
  • FDA Acceptance of Data: Electronic & Paper
  • Computerized systems and eData
  • Basis for Part 11 Compliance and purpose of protection and validation
  • Diverse nature of “source” and how to protect and preserve it
  • Purpose and goal of 21 CFR 11 BIMO inspection
  • Inspection of electronic records – BIMO
  • The 10 Deadly Sins that break compliance
  • Examples of 21 CFR 11 Citations
  • How to prepare your company for successful part 11 inspections.

https://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm

https://www.microsoft.com/en-us/TrustCenter/Compliance/FDA#