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.

Latest Trends in Human Error Issues in the Industry

To say that the manufacturing industry is huge is to make a huge understatement. It is an activity that spans entire industries and is the lifeblood of many economies, right from advanced to developing ones. Despite the advancement in automation in the processes of many industries, manufacturing is still heavily dependent on human labor.

This makes manufacturing an activity that is prone to human error, because wherever there is human involvement, there is scope for human error. Why is this so? It is because as humans, we are not perfect. With all the care and diligence that one is capable of taking, human errors can somehow creep into a manufacturing process.

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Huge costs associated with human errors

There are enormous costs associated with human error in manufacturing, no matter whether the error is intended or unintended. At times, it can affect other activities in the chain and disrupt the process. A human error can sometimes set up a whole chain of errors. Because of this, it is not always possible to make a precise assessment of the loss caused by human error. Yet, rough estimates that the American and British pharma industries suffer put the loss at some $25 billion a year. Human error in this industry leads to unexpected runtime error, resulting in loss of more than a third of the productive time. Human error can result in many losses relating to quality and production and is at the root of many performance issues.

Understanding human error

Even with all the advancements and developments in high end, precise technologies and processes; it is not likely that human error will be eliminated at any point of time. At best, it can only be mitigated and minimized.

Get to the source first

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Many a time, the response to a human error is piecemeal and ad-hoc. Instead, the first step towards containing human error should be to locate its source. 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. Training is an option, but it is surprising that lack of proper training accounts for just a tenth of human errors.

Getting to the root of human errors involves having to control the procedures, training, and workplace environment where many variables that affect human behavior fuse. In order to understand the cause and nature of human error, one needs to directly address the systemic weaknesses to improve or fix them. To do this, it is necessary to get an understanding of human behavior and the psychology of error. Implementation of human factors in manufacturing, the right communication, encouraging continuous practice, the right kind of training, describing the right procedures and offering instructions, facilitating a positive work environment and putting the right processes in place are some of the matters that involve going to the root of human error.

Thorough trainings to help understand human error

A webinar from Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance will offer a complete understanding of the nature of human error, its roots, its psychology and everything else connected with it.

The speaker at this webinar is 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. Please visit Controlling Human Error to understand the whole autonomy of human error.

Practical approaches to all areas of human error

This webinar seeks to help regulatory and quality professionals get a thorough idea of the factors that cause human error. Towards fostering this, the speaker will offer practical approaches and tools to address human performance issues in manufacturing. She will offer an understanding of the human psychology and behavior behind human errors. This will point to where the weaknesses lie, which will help to address the human performance issues. The aim is to help correct and prevent recurrences of human error.

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Ginette will cover the following areas at this webinar:

  • Background on Human Error Phenomena
  • Importance of Human Error Prevention/reduction
  • Training and human error
  • Facts about human error
  • Human Error as the Root Cause
  • What is Human Error?
  • How is Human Error controlled?
  • Common mistakes Memory failures, Overconfidence, We believe we are above average, Visual Detection, Vigilance Effectiveness
  • Types of error
  • Human error rates and measurement
  • Trending and tracking
  • Prediction
  • CAPA effectiveness.

For referal Websites

http://learnaboutgmp.com/the-top-7-how-to-reduce-manufacturing-human-error/

https://hbr.org/1989/03/the-human-costs-of-manufacturing-reform

http://www.pharmtech.com/human-error-costs-industry-billions

7 Keys to Compliance Excellence that Form the Foundation for Any Excellent Organization

In any industry, compliance is everything; be it highly specialized fields such as the life sciences, healthcare, medical devices or non-technological areas such as food and clothing. Why do companies need to be compliant? It is simply because being in compliance with the required regulatory requirements helps the organization to achieve the most positive outcomes needed for a business:

  • It earns them a good reputation
  • Increases stakeholder and customer confidence
  • Augments the value of their products or services
  • Improves performance and operations
  • Maximizes profits
  • Guarantees that they adapt the right processes.

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Meeting the appropriate compliance requirements is mandatory for the regulated industries. This fact is known, but the challenge is in implementing the measures needed for achieving compliance. A compliance program that is built into the organization’s processes and of which it is an inseparable part is the way to go about achieving compliance.

A very comprehensive term

Compliance is a very broad and huge term into which many aspects are built. Compliance has to be shown at all levels by an organization if it has to achieve its outcomes and help the organization fulfil its business and other objectives. Many organizations are somewhat lackadaisical in their approach to compliance, thinking that it is an auxiliary function and not a core business activity. They cannot be more mistaken.

It is more than just a duty that needs to be completed to satisfy regulators. An organization should strive to reach levels of excellence in compliance. Those who fail to do this are not aware of the colossal opportunity they miss to stay ahead of the competition. Excellence in compliance opens the key to several unimaginable opportunities. It leads to high levels of positive results. Achieving levels of excellence at compliance standardizes and optimizes processes and makes them safe, reliable and efficient.

Understand how to achieve excellence in compliance in all its depth

Want to understand how to achieve this in all detail? Then, you could enroll for a highly educative and informative webinar on this topic that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. Please register for this webinar by visiting Achieving Compliance Excellence

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Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that works with both domestic and international clients designing solutions for complex training and documentation issues and is celebrating its twentieth year in business in 2017; will be the speaker at this webinar. A regulatory and management consultant and an Instructional Technologist for 30 years; Charles has published numerous white papers on various regulatory and training subjects.

Seven keys to compliance excellence

At this course, Charles will explain the seven critical keys to achieving compliance:

  • Understanding the regulations that pertain to one’s industry and business throughout each level and function of one’s organization
  • Defining the critical processes relative to the regulatory path that has been chosen
  • Developing sound regulatory documentation
  • Harmonizing processes and procedures between plants
  • Committing to and executing comprehensive technical training
  • Instituting a sound and effective complaint and investigations handling process
  • Managing performance up and down the line to the performance structure created. If it is not managed it will not be performed.

At this session, which will be ideal for Directors, Managers, Scientists, Technicians and Associates; Charles will cover the following areas:

  • Understanding the Regulations that Pertain to your Industry and your Business throughout each Level and Function of your Organization
  • Defining your Critical Processes and why that is important
  • The Benefits of Developing Sound Regulatory Documentation
  • Why Harmonizing your Processes is Critical to Consistency in Operations and Regulatory Compliance
  • Why Technical Training is Essential to every Aspect of Business Operations to include Meeting and Exceeding Regulating Requirements
  • Institute a Sound and Effective Complaint and Investigations Handling Process
  • Performance Management – the glue that holds everything together and Guarantees Acceptable Performance throughout the Organization.

Understanding and applying ICH Q3A and Q3B

The ICH Q3A and Q3B are guidances on dealing with impurities in new drug products. These documents have been issued by the FDA and are updates of earlier versions on the same topic that were prepared by the ICH, which this FDA guideline complements. This is why the documents get their name. The FDA keeps revising these documents from time to time. After every revision, the latest version carries the added taxonomy of “R” to denote that the guidance is a revised one.

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The Q3A and the Q3B are two revised guidelines that relate to impurities in drugs. Impurities can happen due to a number of reasons. These are some of them:

  • Raw materials
  • Byproducts
  • Residual solvents
  • Reagents
  • Product reactions
  • Catalysts
  • Foreign impurities
  • Product degradation

The ICH guidelines Q3A and Q3B deal with the ways of addressing organic and anorganic substances, respectively.  They both follow the principles of reporting, identification and qualification of impurities at defined limits. They both exclude impurities arising out of the excipients of drug products.

Scope of Q3A

The scope of the Q3A guideline is limited to testing of impurities in new drug substances. It concerns itself with the content and qualification of chemical substances in new drugs. It is not meant for products derived from herbal, crude, animal or plant, or semi synthetic origin. It is also not for products in the clinical trial stage or for addressing extraneous contaminants, polymorphic forms or enantiomeric impurities.

Scope of Q3B

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The scope of the Q3B guideline differs in some ways from that of Q3A. It is meant for the content or qualification of degradation products. It excludes products of all the sources that Q3A does, and additionally also excludes impurities arising from excipients or extractables/leachables of the container closure system.

Thorough and full understanding of these guidelines

It is to offer a complete and thorough knowledge of how to apply the Q3A and Q3B guidelines that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. Greg Martin, who is the President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry and served as Director of Pharmaceutical Analytical Chemistry (R&D) for a major Pharma company for a number of years during his over 25 years of experience in the pharmaceutical industry; will be the speaker at this webinar.

To gain clear insights into how these ICH/FDA guidelines apply to your laboratory or area of work, please register for this webinar by visiting Applying ICH Q3A and Q3B for Control

All about the guidelines and regulatory expectations

The objective of this webinar is to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants, including DNA reactive/potential genotoxic impurities, in drug substances and drug products.

Participants who complete this course will be able to:

  • Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals
  • Understand what specifications will conform to regulatory expectations
  • Develop a process for reporting impurities and addressing OOS situations

Greg will cover the following areas at this webinar:

  • Landscape of impurities requiring control in pharmaceutical products
    • General impurities: elemental impurities, residual solvents, microbiological
    • Drug-related impurities process impurities, degradants, potentially genotoxic impurities
  • Process Impurities
    • Understanding ICH Q3A
    • Where impurities originate
    • How impurities are characterized
    • How specifications are developed
    • How impurities should be reported
  • Degradants
    • Understanding ICH Q3B
    • Where degradants originate
    • How degradants are characterized
      • Potential genotoxic impurities
    • How specifications are developed
    • How degradants should be reported
  • Questions and discussion

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.

Putting the MS Excel VBA to optimal use

Visual BASIC for Applications (VBA) is the programming language built into MS Excel and other MS programs. It is a macro, which, as we know, is a recording of a series of tasks. At a simple level, it can be thought of as a smaller version of programing in that once certain tasks are assigned to it, it carries them out.

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The main function of a macro is to work within a program such as MS Excel and automate tasks that need to be performed over and over many times. Because of this function, MS Excel carries out many tasks that would otherwise have to be done manually. Obviously, this is a great time saver, because the time that needed to be spent on manually carrying out a host of repetitive tasks can now be put on something constructive.

 

Overcoming the limitations

MS Excel has a macro recorder, but it has its limitations. So, VBA takes over where the macro recorder’s functionality ends. At a more advanced level, VBA enables the user to carry out many functions, such as:

  • Building your own worksheet functions
  • Creating automated workflows
  • Controlling and interacting with other applications, plus much more.

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Get to understand how to use VBA better

Want to know how to make the fullest use of the VBA function in MS Excel? Then, you need to attend a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Mike Thomas, founder of theexceltrainer.co.uk will be the speaker. Mike 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.

To gain complete knowledge of how to make use of the VBA feature; please register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501317LIVE?Wordpress-SEO

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Mike will get participants started with the VBA. Both advanced and small users of Excel, with little or no programming experience, will be able to take their level of automation knowledge beyond the macro recorder. Even those who have never used VBA before and want to learn about the basics of VBA and automation will find this webinar useful.

People who use MS Excel in their daily work, 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 derive benefits from this webinar.

Mike will cover the following areas at this webinar:

  • Getting familiar with the VBA Editor
  • Understanding VBA jargon such as procedures, modules, methods and properties
  • How to edit an existing macro
  • How to write a simple macro from scratch using VBA
  • Creating inline documentation
  • Using VBA to control what happens a file is opened or closed
  • Using VBA to repeat a series of actions (simple loops)
  • Writing simple conditional statements (IF).

Food safety concerns and issues and ways of mitigating them

Food, despite being the most important human need, is fraught with many risks and hazards. The food chain, which consists of activities that cover everything from the proverbial farm to fork, passes through many points at which a harm of any nature can happen. The chances of risks to the food safety chain are all the more amplified in this age of globalization, when food travels through many regions and continents from its source to its destination.

The UN’s Food and Agricultural Organization (FAO) has identified five major issues with the food chain. These are:

o  Hazards of a microbiological nature

o  Residues left over by pesticides

o  Food additives

o  Chemical contaminants, such as pesticides; and

o  Adulteration.

Many other risks

Of late, this list has been extended to include genetically modified organisms, allergens, veterinary drugs residues and growth promoting hormones used in the production of animal products.

Further, other hazards to the food chain include antibiotic resistance, demographics, meaning the proper distribution of food to the right people, the effects from the environment, and foodborne illnesses. This clearly shows that there is no dearth of sources of hazards in the food chain.

Defining food quality and food safety

While these are the commonly identified areas of the food chain that are considered hazardous; a more fundamental issue for food specialists is in defining food quality and food safety. These have different meanings for food specialists. Identification and elimination of all the hazards that make food injurious to the eater is part of food safety. Anything that gives and enhances the value of the food to the consumer is considered a characteristic of food quality. Food quality can also include any negative traits such as spoilage, discoloration, rotting and stench, all of which affect the quality of food.

In view of the nature and expanse of the points at which hazards can happen in the food chain; it is necessary that there has to be a global cooperative effort aimed at checking these and ensuring food safety. Ensuring food safety at the local, national and global levels requires a high level of cooperation and coordination, not to speak of the sheer perseverance needed for it. A number of safety and quality standards have been in place for the food industry to adhere to. Compliance with these regulations goes a long way in eliminating a number of hazards and ensuring the quality and safety of food along the chain.

A webinar on food safety

All the aspects of food safety will be covered at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Michael Brodsky, who brings varied and deep experience of over four decades into food safety aspects and holds the position of lead auditor/assessor in microbiology for the Canadian Association for Laboratory Accreditation (CALA) and is a member of the Board of Directors among many others, will be the speaker at this webinar. To understand all the aspects of food safety from the expert, please register for this webinar by visiting

http://www.compliance4all.com/control/w_product/~product_id=501352LIVE?Wordpress-SEO

Thorough understanding of all the aspects of food safety

At this webinar, Michael will address the complexity of defining safe food. All the important aspects of food safety, such as the changing nature of foodborne and food transmitted pathogens, new and emerging analytical technologies and the influence of demographics and geography on the changing landscape, and the roles and responsibilities for various stakeholders along the food chain in identifying and eliminating foodborne illnesses and contamination will be discussed at length.

With the world’s population burgeoning, especially in areas that are vulnerable to food safety issues, emerging pathogens present a set of new challenges to everyone in the food chain, such as food producers, food safety regulators, consumers and food microbiologists. Michael will highlight these issues and explain what responsibilities each of us has in ensuring that food is safe and what cooperative efforts we must all put towards attaining this objective.

Michael will cover the following areas during this webinar session:

o  Defining food safety

o  Risks and realities

o  Statistical reliability

o  New and emerging analytical technologies

o  The multiplicity of interacting factors

o  The changing landscape

o  Mitigating the risks.