Relationship Between an EM Excursion Program and CAPA

The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom environmental monitoring are stringent and scientific. The FDA proceeds on the thinking that nil contamination of not only cleanrooms, but all locations involved in aseptic processing is not possible.

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Based on this thinking, the FDA has formulated its guidelines on cleanroom EM taking into consideration the limitations of obtaining completely microorganism-free environment for cleanrooms. It seeks to bring about a consistent EM system that meets high environmental quality requirements all the time, being able to detect changes and deviations in this consistency level and bring the level to control limits.

Regulations that cover all areas of cleanroom environmental monitoring

Keeping this in mind, the FDA has formulated regulations that cover all aspects of cleanroom environmental monitoring, starting from the buildings and facilities, right up to the qualification and training required for personnel manning these cleanroom facilities to what should go into closures to validation of the aseptic processing and sterilization techniques. These cGMP regulations are found in 21 CFR Parts 210 and 211.

All the disciplines of cleanroom monitoring, such as quality, manufacturing, engineering, quality, environmental monitoring, sterilization and cleaning and many others need to be taken into full consideration while building an FDA-compliant monitoring program. These should be included all along, into all these phases:

  • Planning phase
  • Design phase
  • Construction phase
  • Commissioning phase
  • Qualification phase
  • Submission phase
  • Operational phase

A complete understanding of the FDA’s regulations

The ways of understanding and implementing the FDA’s regulations for environmental monitoring program will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

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The speaker at this webinar is Joy McElroy, who in over the 20 years of total experience she has had in the pharmaceutical and biotech industries has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous companies.

Want to learn the ways of understanding FDA regulations for environmental monitoring? Then, please register for this webinar by visiting

Ways of ensuring compliance

Joy will highlight the importance of compliance with the FDA regulations on environmental monitoring, as the costs of noncompliance are much more exorbitant than those of compliance. Participants who take part in this training will be able to get a proper grasp of how to implement a cleanroom Environmental Monitoring (EM) program that complies with the FDA’s regulations.

She will describe the basis of the four phases of cleanroom transitional monitoring (Pre-qualification through post-qualification EM) and explain what each type stands for. In addition to describing what has to be the basic content of a well-designed, effective and compliant EM Program; Joy will also go on to help participants comprehend the relationship between an EM Excursion Program and CAPA.

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This training session is of high value to Quality Control, Quality Assurance, Microbiologist, Facilities, Chemist, Analysts, Manufacturing, Validation, Engineering, Sterility Assurance, Compliance, Testing Technicians, Environmental Testing Personnel, Raw Materials Manufacturers, Clinical, Research and Development, and Laboratories.

Joy will cover the following areas at this webinar:

  • Applicable Regulations – Where does the EM Program fit in the Regulation? – Role of Clean room Environmental Monitoring Program?
  • Basics of Setting a Robust and Effective EM Program – Key Considerations – Relevant Material Verification Processes – Steps and Content of an EM Program Testing Procedure
  • Processing a Completed Environmental Monitoring Test Media – Sample Handling and Incubation – Documentation and Data Management of EM Test Results – What is the EM Test Data used for? – Retention of EM Test Results – Interpretation of EM Test Results
  • Basics of Designing an Effective and Compliant EM Trend Reports – Types; Content – Using Trend Report as a Critical Tool and Quality Metrics
  • Basics of Designing an Effective and Compliant EM Excursion Program – Types; Content – Handling EM Excursion Investigation – Handling Impacted Manufactured Batches – Disposition of Affected Products with Failed Clean room EM Test Results
  • Corrective and Preventative Action (CAPA) – Relationship between CAPA and EM Test Data Excursion Investigations Question and Answer Session.

Understanding HACCP and risk based HACCP

Hazard Analysis and Critical Control Point (HACCP) is an important system aimed at bringing down the risk of safety hazards found in food consumed all over the world. It is an internationally recognized system. When it was enacted in January 2011 as part of the FDA’s Food Safety Modernization Act; it was considered a very sweeping piece of legislation for the food industry.

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Identification and control of potential hazards at specific point of the food chain is the soul of an HACCP system. The chain starts with production and ends with consumption. Identifying and controlling these hazards at every point of the chain is challenging in today’s world in which food has become completely globalized.

HACCP suggests the putting in place of mechanisms to control and counter the biological, chemical or physical hazards that could be present or be a potential presence in the food. The HACCP system is designed in such a way such that a company that manufactures, processes, or handles food products in any form can use HACCP for eliminating or minimizing food safety hazards present in its product to acceptable levels.

Implementation is based on two approaches

Proper implementation of the HACCP program involves food companies to implement both these:

  • Prerequisite programs
  • Implementation of HACCP plans

Prerequisite programs:

Prerequisite programs are those programs that a food organization has to put in place at its facility to ensure that all the processes that go into preventing contamination, ensuring a hygienic environment, and the optimal and scientific use of manufacturing methods and technologies and the cleanliness and hygiene of the staff involved in the production of food are proper and compliant.

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Implementation of HACCP plans:

If the prerequisite programs are required at the manufacturer-specific location; many steps and processes need to go into ensuring the quality standards of food that goes out of the facility. HACCP has suggested as many as seven steps for food is free from contamination. These are part of HACCP plans.

 

 

 

These include:

  1. Conducting a hazard analysis
  2. Identifying the critical control points
  3. Establishing a maximum or minimum limit for temperature, time, pH, salt level, chlorine level or other processing characteristics that control the hazard
  4. Establishing Critical Limits
  5. Establishing Monitoring Procedures
  6. Establishing Corrective Actions
  7. Establishing Record Keeping Procedures and Verification Procedures

Risk based preventive control is a major component of HACCP

HACCP has placed a heavy emphasis on risk in the production and transportation of food. It requires risk based preventive control. Codex Alimentarius describes risk assessment as a scientific process that takes the identification of a hazard, its characterization, assessment of the exposure to it, and characterization of risk into consideration.

Risk assessment is part of risk analysis, which in turn is described as a process into which three aspects, namely risk management, risk assessment and risk communication go. So, HACCP requires food manufacturers and transporters to take the risk causing factors into consideration at work. All these become part of risk based preventive controls.

Get the confusion cleared in implementing a risk based HACCP program

To clear the confusions in the meaning of these terms and to teach the ways of implementing them, Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar.  This webinar will clear the misunderstanding between these terms and show ways by which to implement a risk based HACCP program and ways of getting it right.

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Rotimi Toki, who is principal of Rottoks Food Safety Management Consulting Services Limited, will be the speaker at this webinar. Rotimi has provided services to some of the top brands in food service and manufacturing sectors and specializes in Quality Systems Audit, developing an integrated food safety management system based on HACCP principles. In order to gain complete understanding of the ways by which you can adapt and implement a risk based HACCP program, please register for this webinar by visiting Background of The HACCP system

Step-by-step method of developing an HACCP program

Rotimi will present a step-by-step process for developing an effective HACCP program. He will elucidate the principles and specific steps needed for this, for this is a prerequisite to building such a program. Through this process, Rotimi will show how participants can build a plan that can identify and control food safety hazards and risks specific to their product line and processes.

He will show how to determine the significance of these hazards by applying risk assessment techniques, from which a measure of risk can be obtained. This measure allows users to put appropriate control measures in place. He will clarify on the various confusions and weaknesses present in many food safety standards surrounding the determination of control measures required by HACCP.

Rotimi will cover the following areas at this webinar:

  • Background of The HACCP system
  • The CODEX Guidelines
  • Basic HACCP procedures
  • Assemble the HACCP Team
  • Describe product and identify intended use
  • Construct flow diagram and on-site confirmation of flow diagram
  • Hazard Analysis
  • Determining control measures in HACCP
  • Establish Critical Limits for each CCP
  • Establish a monitoring system for each CCP
  • Establish Corrective Actions
  • Verification procedures
  • Documentation and record keeping
  • Post-HACCP Maintenance

Uniform Customs and Practice standard and can be negotiated by over 30,000 banks worldwide

Letters of Credit are the primary instruments for assuring payment of goods sold internationally. This web session is designed to provide attendees with an end-to-end understanding of the L/C (letter of credit) process. From the beginning of a contractual agreement, through the letter of credit application process and actual negotiation of the L/C, this information-rich webinar will provide techniques that are indispensable to both importers and exporters.

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Why should you attend your staff should understand Letters of Credit. Even in today’s free trade-oriented business environment, companies must exercise particular caution when agreeing on payment terms. With financing choices that include cash in advance, open terms, letters of credit (L/C), sight drafts and time drafts, both importers and exporters need to understand the true implications of their credit policies and practices. By login with this Letters of Credit for Importers you may know.

These Things of the areas will be covered by the speaker Douglas Cohen

  • Gain a Comprehensive Understanding of the Letter of Credit Process
  • Learn how to Negotiate the Terms of both Import and Export L/Cs
  • Be 100% aware of Letter of Credit Documentation requirements
  • Be Aware of all Expenses Associated with Using Letters of Credit
  • Learn how to Avoid Amendments and Discrepancies

Understand the role of banks and freight forwarders in the L/C process.

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  • Documentary Credits Defined
  • Letters of Credit for Exporters
  • Sight Drafts and Time Drafts
  • Documentation Requirements
  • Letters of Credit for Importers
  • The Letter of Credit Process
  • Amendments and Discrepancies

Those who are the experts benefited by this

  • Exporters
  • Logistics and Trade Professionals
  • International Sales Executives
  • Customs Brokers
  • Freight Forwarders
  • Airlines
  • Steamship Lines
  • International Banking Personnel
  • Professors and Students of Global Trade

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Douglas Cohen has been at the forefront of international trade and transactions. With positions in private law practice, US Department of Commerce, the European Union, IATA, and American Airlines, he has developed significant expertise in import-export operations and compliance, global transactions, international negotiations, intellectual property, and cross-cultural business communication. At present, Mr. Cohen is Senior Manager, Global Trade and Contracts at Worldwide Trade and Legal Associates (WWTL), where he provides legal and strategic advice to organizations seeking to enter or expand foreign markets.

In addition, he is the director of WWTL’s Global Trade Compliance Training division, where he offers comprehensive import-export training to private companies, universities, and pubic organizations.

Mr Cohen has been asked to teach university courses and corporate seminars on international business and law in the US, Europe, Asia, and the Middle East. He is the author of numerous publications on Internet law, international contract negotiations, intellectual property protection, and import-export operations and compliance.

Understanding and dealing with Automated Clearinghouses (ACH) frauds

Automated Clearinghouses (ACH) are a popular means of financial transactions, as they substitute actual physical paper documents such as cards and checks. ACH’s are an electronic network that facilitate and carry out a huge number of transactions online. In being online and quick; they have grown as a byproduct of the IT revolution and have gained popularity around the world for the ease of payments they cause.

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However, like all other technology-dependent systems; ACH’s bring their own disadvantages. Like all other modes of technological payment methods; ACH’s are prone to a variety of frauds. All that it takes to breach and impugn the systems is some smartness and knowledge of the ways in which they work within organizations or networks. Since ACH’s house almost all kinds of transactions; embezzlement into their systems can typically affect all kinds of payment methods and accounts, ranging from hacking and taking over entire individual accounts to penetration of accounts of business houses.

Companies that deal with ACH’s in one or another form –and there is no dearth of these –need to be constantly on their vigil if they have to prevent large-scale of small-scale swindling of their accounts. Their transactions need to be tightened and made as secure as possible if they have to prevent frauds.

Understanding of the ways by which ACH frauds can be prevented

The ways by which business houses can mitigate and prevent ACH fraud will be the learning a valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be imparting.

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At this webinar, Rayleen M Pirnie, founder and owner of RP Payments Risk Consulting Services, LLC, who is a nationally recognized payments risk and fraud expert who offers specialized consulting services, procedural and risk management reviews, and payments education, will be the speaker.

To gain important lessons into the ways of preventing ACH frauds; please enroll for this webinar by visiting (ACH) frauds

Explanation of the vulnerabilities and ways of handling them

Rayleen will discuss the many vulnerabilities that organizations that rely on ACH’s face. These could range from individual companies to government organizations and departments to NGO’s. Especially aimed at these kinds of organizations that deal with ACH payments for their daily transactions; this webinar will explain the best practices every organization should implement to detect and mitigate the threat of ACH fraud.

Rayleen will explain all the internal controls and processes and services that organizations of any size should discuss with their financial institution for reducing their exposure and risk. The threat of ACH fraud may be high, but much of the fraud can be averted and the potential losses mitigated if the organization knows what to look for and implement the right controls.

She will explain the various types of internal processes and controls that vary by industry and organization size. She will suggest a wide range of options and recommendations that the participants of this webinar can assess and implement based on their own internal protocols.

A bouquet of benefits from attending the webinar

These are some of the tangible benefits that the participants of this webinar will derive from this session:

  • Understanding the ways by which businesses lose thousands of dollars in seconds easily
  • Identifying sound business practices and easy to implement internal controls that are proven to reduce losses
  • Reviewing a few of the common solutions offered by financial institution to further minimize exposure

This session will be of high value to those who deal with ACH’s and other related professionals, such as AAP, CPA, Risk Managers, those in Management, and Investigators.

Rayleen will cover the following areas at this session:

  • Examples of how criminals use the ACH Network to steal from organizations
  • Restructuring and rearranging a Notebook
  • Sound business practices to minimize exposure
    • Variety of options including the dual benefits of dual control and enhanced internal approval processes
    • Enhanced internal controls
      • How criminals use an organizations technology to commit fraud
      • Securing internal payment instructions and approvals
      • Account reviews
  • Stronger account security options
    • Explore most common options including ACH positive pay, debit filters, debit blocks, credit only accounts, account alerts, etc.

Tips on how to save time on MS Excel

Microsoft Excel is a program that has a very high number of features. These features make this program very capable and versatile, since it is suited for a number of usages. If this is good news, the better news is that these features come with simple shortcuts and methods. These need to be explored, since they are not always visible to the casual user. If a user masters the use of these shortcuts, it will be of immense use, because it helps to save precious time, which can be put to more productive uses. There is no doubt that employees who know how to exploit the secrets of MS Excel are likely to be more productive.

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Want to join the gang of people who are proficient in their use of MS Excel through the innumerable shortcuts that come with the program? Then, enroll for a webinar that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance.

The speaker at this webinar, Dennis Taylor, an Excel expert who has worked extensively with Microsoft products, especially spreadsheet programs, for over two decades, will explain the ways by which to optimize the use of MS Excel. All that you need to do to benefit from this expert on how to use shortcuts for MS excel is to enroll for this webinar by visiting Tricks and 100 Shortcuts

A huge number of shortcuts and tips

The purpose of this webinar is to help participants significantly enhance their productivity at work by using shortcuts. Dennis will be offering valuable tips on how to make the best use of Microsoft Excel on the use of the right shortcuts, whether it is a keystroke shortcut or a hidden command sequence.

The speaker will present an unbelievable 100+ Excel shortcuts. Many of these are keystroke shortcuts and many of them concern dragging techniques not involving command sequences. Another important learning he will offer is on how to differentiate between shortcuts when appropriate, depending on the use. These will be explained separately for Excel versions 2016, Excel 2013, and Excel 2010.

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To make the learning of shortcuts more practical and real; Dennis will offer these productivity tips, shortcuts, and accelerator tools throughout the session using Excel worksheets and workbooks that are based on real-life data. These will later be made available to all attendees.

 

Dennis will cover the following areas at this session:

  • Navigate seamlessly through workbooks and worksheets with keystroke and mouse shortcuts
  • Copy or move data with simple dragging instead of multi-step command sequences
  • Display/hide all worksheet formulas instantly; select all formula cells with two mouse clicks
  • Use keystroke shortcuts for a various number formats
  • Build lists of dates, times or values without using time-consuming commands
  • Create charts instantly and learn manipulation tips
  • Create formulas faster with entire column references
  • Master over 100 tips to make you a Power User!

Learn how to build professional, eye-catching form-driven applications and spreadsheets

MS Excel, a wonder program, has umpteen uses for a number of professionals, students, and a host of other users. We have known for long that it can be used to carry out a number of functions that are varied and interesting. However, adding design elements to MS Excel goes a long way in enhancing its aesthetic appeal, as also the effectiveness.

Booking forms, sales order forms, invoices, loan agreement forms and surveys are just some of the endless kinds of forms that can be created using Excel. These can be made a lot more attractive and likeable by just adding a touch of features such as color, cell protection and some drop-down lists and simple validation.

A few simple steps at design

Just a few splashes here and there into these forms, and you will be amazed at the extent to which these bland forms can transform themselves into user-friendly ones that will make data entry simple and error free for everyone concerned, be it the user, her colleagues, or her clients. Small techniques such as this will eliminate the hassle of having to go through the long-winded, repetitive and frustrating experience of entering and editing data into a table in Excel.

This is just one of the many tricks that will be taught at a webinar on adding design elements into MS Excel to make it more illustrative, attractive and useful. At this webinar, the Expert, Mike Thomas, the globally acclaimed guru of MS Office, who has spent over a quarter of a century as a subject matter expert in a swathe of subjects relating to MS Office and Mac, will be the speaker.

Loads of experience

The experience and wisdom that Mike has gained over these years, during which he has been Fellow of The Learning and Performance Institute and has worked with and for a large number of global and UK-based companies and organizations across a diverse range of sectors, will be in full flow at this highly interactive webinar session. Want to know how to optimize the use of design elements into MS Excel to make it more palatable and likeable? Just log on to http://www.compliance4all.com/control/w_product/~product_id=501316LIVE?Wordpress-SEO to enroll and relive the fun of learning about MS Excel.

Adding design elements into MS Excel to save costs and time

The main benefit that people across a spectrum of professions and activities, such as Business Professionals, Business Owners, Researchers, Administration Support Staff Educators, or for that matter anyone who wants to learn how to get the best from MS Excel to manage projects and their life, will gain from this webinar is that they can save the invaluable resources of time and money by learning to enhance the use of forms in MS Excel.

This session is highly useful to smaller organizations that are constrained with limited budgets and will think twice when needed to buy expensive dedicated software to manage the inputting and storage of information. This of course, does not preclude bigger companies from this learning.

Using other MS Excel features to create forms

The speaker will enable participants to follow real-world examples to learn how to build professional, eye-catching form-driven applications and spreadsheets. Since there is no option for creating a form; Mike Thomas will teach participants how to use a number of other built-in MS Excel features to create forms and then subsequently make them attractive with its design.

Mike will cover the following areas at this webinar:

o  Naming cells-to make formulas easier to understand

o  Drop-down menus and checkboxes-to make data entry easy

o  Data validation and protection-to reduce the risk of data-entry errors

o  Formatting-to make your forms inviting to use

o  Formulas and functions as VLOOKUP

o  Simple automation.

The art of writing effective audit observations

Audits are a means of evaluating operations and other functions of an organization. ISO 19011:2011 Guidelines for Auditing Management Systems describes audits as a process used for gathering the evidence of verifiable documents and map their suitability, alignment and fulfilment with the company’s policies and procedures.

An audit is an important tool that helps organizations to analyze opportunities, implement best practices, and assess all the important factors in a business, such as risks, ethics, controls and quality. Conveying these to the management is the primary aim of an audit.

An audit is indispensable for mitigating risks and ensuring governance. An audit can be either:

o  Internal, where an organization’s employees in charge of audits in an organization in charge of audits carry out audits, or

o  External, where an external, independent auditing professional examines and evaluates the company’s functions objectively.

Each of these two types of audits is important. Either of these may be required, or both may be required, depending on the kind of business and practices an organization has.

Broadly, these are the types of audits:

Financial audits: Financial audits, as the name suggests, are related to how an organization keeps financial controls in place and report them to the authorities. Financial audits are summed up in financial statements, which spell out the extent to and the ways by which financial aspects of organizations tally.

Operational audits: These are the audit or assessment and evaluation of how an organization actually carries out its business. Being of this nature; operational audits are concerned primarily with business processes. The aim of operational audits is to suggest ways by which organizations can improve their operations to optimize their businesses and increase ROI.

Compliance audits: These are carried out to ensure the compliance with regulatory requirements in an organization. A number of these regulations need to be complied with depending on the nature and location of business.

Information Systems: Since no organization can stay aloof from automation and since information systems are required for almost all functions in an organization; it needs to systematically and thoroughly review its information systems from time to time. An effective information systems audit takes not only existing, but also emerging technologies into consideration and suggests ways by which to improve its network and firewall its data security.

Integrated Audits: Suggestive of its name; an integrated audit is one that assesses, monitors and controls all the kinds of audits –Financial, Operational, Compliance, and information systems risks. Auditing professionals locate these integrated audits on a business process or cycle or part of it.

Understanding and carrying out operational audits

Operational audits, being among the important kinds of audits, are governed by their own set of standards. They have their own set of standards that need to be complied with. These are set out by The Institute of Internal Auditors (IIA). And, like other types of audits, operational audits require a high degree of knowledge, diligence and skill.

The ways and means of carrying out operational audits can be complex and requires adherence to a number of standards and best practices. Auditors need to be thorough in their understanding of how to do these in an optimized fashion and ensure results for the organization.

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be providing this insight at a highly educative webinar. Jonnie T. Keith, who has over 40 years of audit experience and has served as the Chief Audit Executive for the Metropolitan Atlanta Rapid Transit Authority (MARTA) for the past 10 years, will be the speaker at this webinar.

To enroll for this session and to gain from the expertise Jonnie brings into auditing, please visit http://www.compliance4all.com/control/w_product/~product_id=501309LIVE?Linkedin-SEO

A complete roundup of operational audits and the ways of writing audit observations effectively

At this webinar, Jonnie will explain the intricacies of an operational audit. Jonnie will explain the importance and ways of writing these audit observations effectively and compellingly. He will explain the concept and all the important aspects that go into operational audits, such as management responsibilities and the key IIA standards that go into audits and the areas of their purview, such as the following:

2010 – Planning

2201 – Planning Considerations

2220 – Engagement Scope

2240 – Engagement Work Program

2300 – Performing the Engagement

2400 – Communicating Results

2500 – Monitoring Progress

http://asq.org/learn-about-quality/auditing/

https://finance.columbia.edu/content/types-audits

http://www.accountingtools.com/operational-audit

https://na.theiia.org/about-us/about-ia/Pages/About-the-Profession.aspx