Design Verification and CAPA Effectiveness Checks [Plans for Process] Validation

How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates.

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This is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

  • How to link risk with the confidence statements associated with the sampling plans
  • Identify a variety of sampling plans, that all make the desired confidence statements
  • Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation
  • How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates

Approaches and sources of such plans are explained and contrasted with manufacturing sampling plans.
Ensure compliance when selecting sample sizes.
Learn strategies for reducing sample sizes.
Learn strategies for avoiding false rejections.

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  • Claims that can be made when passing a sampling plan
  • How to select a sampling plan to make a specific claim
  • Different types of sampling plans including single, double and variables
  • How to reduce the number of units tested
  • How to increase the chances of a good product/process passing a validation
  • How to write protocols to handle contingencies so to avoid deviations
  • Practical considerations including selecting representative samples

Sampling Plan Analyzer and Distribution Analyzer software packages as well as providing consulting and training on Statistics including Robust Design, Tolerance Analysis, Design of Experiments, Trending and Acceptance Sampling.

Virtual Seminar on In-Depth Computer System Validation [FDA Compliance]

You should know the key areas most scrutinized by FDA during inspection to prepare for future audits.

How to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, and You’ll learn about the various computer system.

validation deliverables and how to document them through the entire process, also learn about what must be done to ensure the system remains in a validated state.

We will also review recent trends in FDA enforcement and highlight key areas of CSV that are being scrutinized most heavily.

This will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.

This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.

It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.

You should also attend to learn the key areas most scrutinized by FDA during inspection to prepare for future audits.

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good “variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice, Good Clinical Practice (GCP)
  • Validation Planning
  • GAMP 5 System Classification
  • Risk Assessment
  • Functional Requirements Specification
  • Configuration and Custom Coded Solutions
  • Installation Qualification (IQ) Testing
  • Operational Qualification (OQ) Testing
  • Performance Qualification (PQ) Testing (User Acceptance Testing/UAT
  • Validation Summary Report
  • Operational Maintenance for Validated Systems
  • Policies and Procedures
  • Training
  • Organizational Change Management (OCM)
  • Periodic System Review
  • Disaster Recovery and Business Continuity Planning
  • System Retirement
  • FDA Recent Inspection Trends and Key Areas of Focus

GMP Training Specialists

Want to Reduce Your Human Error? You Need to Read This First

The human operator, while being integral to a system, is also the root cause of most human errors.

Fremont, CA: “Why Humans Error and What We can do About it” is the title of a webinar that is being organized by Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, on January 23. Ben Woodcock, a Human Factors Consultant who have more than 20 years of experience of applying his discipline across several industries, will be the speaker at this webinar.

Please visit http://bit.ly/2RyQKXl to enroll for this webinar.

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No matter to what extent automation may seem to be taking over from many human functions in many industries, complete automation to a point where human intervention is not at all necessary is not going to materialize in the near future. Humans continue to be the driving force in most industries across the world.

The human operator, while being integral to a system, is also the root cause of most human errors. Although there are no thoroughly verifiable estimates and statistics on the percentage of major incidents for which human error is a contributing factor, one can put it at between half and as high as nine-tenths. This being a very high, but plausible figure, it is very crucial for organizations to get a complete understanding of how human error originates and of the factors that create and perpetuate human errors.

Understanding the reasons for human failure is the basis to putting an effective mitigation program in place. This helps to target the root causes of human error and to select the course of mitigation that is appropriate, cost-effective, and delivers the necessary action. Just as it is impossible to replace humans to do most work, it is unrealistic to expect that human error will disappear. Although it is accepted that it is human to err, the aim of organizations should be to reduce human error.

Want to reduce your human error? You need to read this first

This webinar is intended to provide an overview of how humans make errors and to detail some techniques used by human factors professionals to identify potential errors and target effective mitigation measures.

At this webinar, the speaker, who has been providing Human Factors leadership to many major design projects and operational systems and is the author of several published papers in the fields of Risk Management and Human Factors, will offer an overview of how humans make errors. He will help participants explore techniques that Human Factors professionals use for identifying potential errors and help adapt effective mitigation measures.

Mitigating errors in each part of the system

All systems have goals, either single or multiple. Each part of a system should be designed to successfully execute its task or tasks in a manner that contributes to achieving the goal or goals set out by the system. So, the system should be designed and operated in a way that mitigates failure of each part of a system, so that the system reaches its goal.

The learning that Ben will offer will help participants to examine the decision-making process, familiarize themselves with the influencing factors surrounding human error, and understand the ways of identifying appropriate mitigation measures.

In this webinar, which will be of immense value to strategic and operational decision makers within complex systems, operators within complex systems and safety professionals, Ben will cover the following areas:

  • The Fundamentals of Decision Making
  • Situational Awareness
  • Cognitive Bias
  • Human Factors Approaches for Identifying causes of human error
  • Developing and Applying Appropriate Mitigation Measures.

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About the speaker:

Ben Woodcock is a Human Factors Consultant who is Project Delivery Director at SNC Lavalin’s Rail and Transit Division, and is based in Calgary, Canada. Ben has more than 20 years of experience in his career, during the course of which he has applied the principles of Human Factors across a wide swathe of industries such Rail and Transportation, Energy and Defense. His work has taken him to several countries including the UK, USA, Canada and UAE.

Ben has contributed Human Factors leadership to various flagship design projects and operational systems. Some of the acclaimed projects on which Ben has worked include the Eglinton Crosstown Light Rail Transit, Olympus TLP, Big Foot TLP and the Channel Tunnel Rail Link. During the years of working in the industry, he has developed a clear understanding how to optimize safety and design by integrating Human Factors into all stages of the design and operating processes.

Ben is also the author of several published papers in the fields of Risk Management and Human Factors. He has contributed to several Process Safety textbooks.

Webinar from Compliance4All on January 9, 2019 on Supervising a Human Error Free Environment

The tools that the speaker will offer at this course can be used for implementation immediately.

Fremont, CA: Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a webinar on January 9, 2019. The topic of the webinar is “Supervising a Human Error Free Environment: You can do a Lot More than you Think”, and the speaker is Ginette Collazo, an Industrial-Organizational Psychologist.

To enroll for this webinar, please visit https://www.compliance4all.com/control/w_product/~product_id=502284LIVE

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In many industries, despite the many advances that have shaped safety standards, human error is still a factor to be reckoned with seriously. Human error, despite taking what one thinks are the best precautions, can lead to loss of quality, processes and production, not to mention the financial one.

What is needed is a comprehensive approach to elimination of human error. While it is acknowledged that human error can never be eliminated, one can take care from many angles and perspectives to minimize it. This should start at the design stage. Good Manufacturing Practices (GMP) regulations need to be implemented in complete faith. The approach should be to identify the root of the human error first and then take the necessary steps to address them.

These should be done in complete sync and harmony with the concerned staff members in charge of safety and in accordance with the principles of GMP. The specific methodologies needed for implementing these will be the essence of the learning this 90-minute webinar will impart.

The speaker will explain strategies with which the unit can use a specific methodology with which to sync and approach issues in GMP related environments that uses a method for correcting, preventing and avoiding recurrence of these issues. She will also describe the practical approaches that can be adhered to while supervising on the floor.

She will also drive home the importance of supervision in reducing and preventing human error and show ways by which to implement metrics that can help track and measure human error rates. The five elements of ensuring a human error-free environment will be discussed at this webinar. The tools that the speaker will offer at this course can be used for implementation immediately.

This webinar will serve the following learning objectives:

  • Understand human error: factors and causes
  • Understand the importance of supervision in creating a high reliable group for both regulatory and business compliance
  • Discuss issues related to supervision and how to avoid traps that will allow errors to occur
  • Identify Root Causes and CAPA associated to supervision.
  • Learn how to measure human error rates at your department and keep track of metrics
  • Identify what I can do to support human reliability at the site.

This course will be beneficial to Supervisors, Managers and Directors, Operations, Manufacturing, Plant Engineering, QA/QC Staff, Process Excellence/Improvement Professionals, Industrial/Process Engineers, Compliance Officers, Regulatory/Legislative Affairs Professionals, and General/Corporate Counsel.

About the speaker:

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

Food Safety and Quality in Home Food Delivery

Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene.

Among the many conveniences that technology has ushered into our lives is the facility of ordering food online and eating whenever we want to, instead of having to necessarily visit hotels or restaurants. Coupled with another recent phenomenon that has changed our lives forever-globalization-the home delivery market is growing at a terrific rate. It is pegged at between $45 and $50 billion annually, and is expected to grow at a rate of more than 50% by 2022.

This huge industry, part of the wider and bigger food supply chain industry, which involves many players and activities in meeting its demand; is often characterized by ignorance about the most vital aspect of food: hygiene. This is an industry, like say, healthcare, whose efficiency depends more on the last mile provider, than on planners and high-level managers and strategists. It is this foot soldier on whom the industry actually runs, in a sense. Yet, the home food delivery market is characterized by a shocking lack of knowledge about food hygiene on the part of these delivery personnel. If this is the story of a hygiene-obsessed country such as the US; one can imagine how appalling the situation must be globally.

food chain

One can attribute a twofold reason for this situation: the diverse and fragmented nature of the food delivery business, and the near total absence of regulation in it. It is thus an irony of the food delivery business that while the business continues to grow in terms of attractive numbers; the core aspect of food delivery, cleanliness, continues to suffer.

Regulatory controls lack teeth

Many consequences result from the lack of hygiene standards. Lack of hygiene affects products of daily use, such as poultry products, meat and other related foods. Consumers, most of whom are in the productive age group, fall sick often. When this happens, the economy’s productivity levels drop. Plus, it puts a heavy burden on the already overstretched healthcare sector.

There is the existence of a law on food safety: the FDA’s Food Safety Modernization Act (FSMA), which has rules relating to areas of the food supply chain such as distribution from the point of produce, documentation -especially for imported and exportable items- and supply chains. This fact notwithstanding, the FSMA is not potent or comprehensive enough to ensure hygiene at the critical source at which food is most vulnerable: the last mile supplier, or the food delivery point.

Get to understand the elements of food delivery hygiene

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering a course in which the core areas of safety and sanitation aspects of home food delivery will be explained. Dr. John Ryan, a highly acclaimed expert on food safety, will be the speaker at this very high value webinar. Dr. Ryan is the Founder of John Ryan Systems, which he founded after gaining expertise in all the areas of the food safety industry for three decades, during which he worked in sectors such as manufacturing, food, transportation and Internet industries.

Please log on to http://bit.ly/2HxZTdK to enroll for this webinar and to gain insights into Dr. Ryan’s vast knowledge of the food supply industry.

Understanding the reasons for which food gets harmed

The ambit of this webinar is an explanation of the vulnerabilities that food in the food home delivery industry is exposed to. Dr. Ryan will explain the regulations that need to be complied with to ensure the safety of food, as well as the consequences of lack of compliance. Complying with regulations apart, food suppliers have to be more knowledgeable about how activities on their part can prevent disease outbreaks. Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene. This is one of the major discussions of this webinar.

Dr. Ryan will explain how food supply companies that seek to get away from the reach of the law by deceptive and escapist recourses such as disclaimers can be hauled up.

food

At this webinar, Dr. Ryan will cover the following areas:

  • The issues of food safety and quality
  • Basic food sanitation and temperature controls
  • Appropriate dunnage
  • Evolving home food delivery Technology
  • Types of foods in the home food delivery market
  • Ordering models
  • Recall requirements
  • Integrated Online Ordering Companies
  • Call in or online orders
  • Some of the industry players.

How can a Culture of Quality and Compliance Impact your Company’s Success?

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality.

If there is one attribute that sits at the very core of an organization, it has to be Quality. If Quality is this critical to organizations; then, what is Quality in the context of an organization?  If Philip Crosby defined Quality as conformance to requirements and Sam Walton considered it as being able to give the customers what they want; William A. Foster explained Quality in an organization in the following words: “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wise choice of many alternatives”.

Those in charge of Quality in organizations have to consider many questions relating to it. These are some of them: do we consider it an attribute or characteristic in relation to a certain standard or customer requirement? Is it all about achieving a state where our product is free from defects? Is it a system that we create for holding inspection standards or making the Quality System accountable to? Or is there something beyond all these?

Quality should become part of the organization’s culture

If there is one truly critical work that an organization has to carry out to become successful and to stay ahead; it is to imbibe Quality into its very core. Going beyond the semantics; Quality should become a way of life for the organization. it should become a philosophy, an inalienable part of its culture, and a habit. For organizations to meet and exceed customer expectations all the time and every time, Quality has to be implanted into the very essence of an organization.

Compliance4All, a well-known provider of professional trainings for the areas of regulatory compliance, explain all the elements of Quality at a webinar that it is organizing. Susanne Manz, a highly regarded leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma, and who brings extensive background in Quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the speaker at this webinar.

Please register for this webinar by visiting http://bit.ly/2Hs2QMI

Quality from all perspectives

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality. Among the important learning objectives of this session is to teach participants to identify the warning signals that indicate that there could be Quality issues within the organization and the risks the organization faces from Quality and compliance issues. Participants will understand the ways of changing their organizations from being reactive to becoming proactive. Participants will understand how a culture of Quality and compliance can impact their organization’s success, and will learn the ways of creating a culture of Quality and compliance at all levels in their organization.

Suzanne will cover the following areas at this webinar:

  • FDA and NB expectations for Quality Systems
  • Lessons Learned from 483s and warning letters
  • How culture can impact Quality and compliance risk
  • Management commitment and responsibility
  • Maturity Modeling
  • Key capabilities
  • Roles and responsibilities
  • Quality planning and strategy
  • Tools and techniques
  • Best Practices.

Where does GMP Training end and HR training begin?

HR could be in a predicament about what kind of training to impart to consultants.

That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).

This FDA section underlines the need for educational qualifications, training and experience to carry out their job functions, which cannot be carried out in the absence of these requirements. The consequences of having ill qualified and ill-equipped staff can be of a grave nature. This scenario calls for a thorough look at the way pharmaceutical companies select and train their staff engaged in their work that must incorporate Good Manufacturing Practices (GMPs), while also maintaining quality, which is of paramount importance in this industry, all within the ambit of the organizational culture.

Challenging questions relating to training requirements

Meeting the educational and training requirements for pharmaceutical professions in a GMP environment, while complying with the provisions of 21 CFR 211.25(a) can be quite a challenge for the pharmaceutical companies’ HR. HR training should align with the requirements set out by Quality Assurance. There must be consistency and alignment of the priorities and need of the stakeholders in these two crucial departments.

successful-employees

HR could be in a predicament about what kind of training to impart to consultants, a practice that is quite prevalent in this industry. Are they to be trained the way regular staff is, or do they have a different set of training requirements? Another practice that abounds in this industry is transferred employees. What about the training for such employees?

Get to understand the elements of onboarding in a GMP environment

A webinar from MentorHealth, a leading provider of professional trainings for healthcare professionals, will be setting doubts relating to all these core areas at rest at a webinar that it is organizing. The speaker at this webinar is Michael Esposito, who has over 30 years of experience in the pharmaceutical industry, during which he has world in a variety of areas including packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations in many reputable companies such as Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division. Michael has more than 17 years’ experience in GMP training and document management.

Please visit http://bit.ly/2HJdw93 to enroll for this very useful session.

Familiarization with the onboarding strategy

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The essence of this webinar is familiarization with the onboarding strategy needed for professionals in the pharma industry. Michael will help participants understand how to put in place an onboarding strategy that combines the inputs of all the major stakeholders and put in place a consistent and comprehensible onboarding and training process that the organization can adapt for its employees.

Participants at this webinar will be able to define the onboarding process in the context of compliance. Michael will help them understand how to interact with HR to create a coordinated onboarding strategy. They will be able to implement a training program that takes into account the differences between the training requirements for full-time employees and contractors, and between new employees and employees transferring internally. They will also be able to prioritize training, so that they not only ensure compliance; they also reduce the learning curve for new or transferred employees.

This session is of value to professionals such as Managers with direct reports, HR professionals, and Quality Assurance and training departments. Michael will cover the following areas at this webinar:

  • FAQs for employee onboarding
  • Management’s expectations for new employees
  • HR onboarding
  • Quality’s role in the onboarding process
  • GMP training requirements
  • Handling full-time employees vs. contractors and other temporary personnel

Benchmarks for training and competency.