New Way of Exploring Economic Environment

Lineament analysis in geological exploration

The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration.

The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to achieve the best possible confidence in resultant mineral resource and reserve estimates.

Getting Quality Assurance and Quality Control procedures and protocols right is crucial

Accurate and proper QA and QC procedures and protocols are essential to ensure that data collected and created by the mining organization is of a high level of quality and is in compliance with CIM Standards and Guidelines. Geological quality control procedures are meant to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying. The quality of the data used determines the quality of an estimate.

To offer a complete understanding of this concept, GlobalCompliancePanel, a reputable provider of professional trainings for all areas of regulatory compliance, will be organizing a two-day, live seminar. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900719SEMINAR?new-economic-environment-Boston-MA.

The Director of this seminar, Ricardo Valls, will introduce to the participants a methodology that will help them to concentrate their exploration efforts even over new areas with limited or nonexistent geological information, while keeping their budget in check.

The centrality of QA&QC procedures

Ricardo will explain how lineament and satellite interpretation are a way to define where to concentrate exploration efforts, as well as how to implement QA&QC procedures to guarantee the quality of the collected data. This is necessary, considering that compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets. Quality assurance is essentially the management system that operates to ensure credible results. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability.

The learning will be gleaned from a quality assurance program that the Director has implemented for the field sampling procedures. This includes collection, labeling, and shipping components. The quality control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as:

o   The adherence to written protocols; up-to-date and suitable training of personnel

o   The use of reliable laboratories with excellent QA&QC systems in place

o   The regular use of quality control (QC) samples (blanks, standard samples, and field duplicates)

o   Diligent record keeping.

Ricardo will cover the following areas at this seminar:

o   History of the problem, why we need to change the current approach

o   Lineament analysis

o   Lineament analysis and satellite interpretation of data

o   Physical modeling (3D strain analysis and 3D stress analysis)

o   Statistical procedures (Compositional data analysis, correlation analysis, principal component and other methods)

o   Defining a QA/QC program, Blanks, duplicates, standards, external controls

o   Procedures and audits

o   Rock naming in the field

o   Conclusions and recommendations.

FDA Concepts for Medical Device Companies

Putting a well-rounded and comprehensive Quality Management System

An efficient and effective Quality Management System (QMS) is a critical factor for the success of medical device companies. Having an effective QMS in place is absolutely necessary for medical device companies that have to satisfy the needs of all of their stakeholders. Further, an effective QMS is a means to ensuring that a medical device company’s products are safe and effective for its customers.

A medical device company has to show compliance with the necessary regulations. It should also enable the company to successfully demonstrate that compliance to the regulators. At the same time, this QMS system also needs to be efficient to allow medical device companies to meet the needs of their business stakeholders and shareholders.

Get the QMS right to show compliance

It is necessary for medical device companies to know how to put in place a QMS that meets all these varied and complex requirements. When medical device companies get trained on how to get their QMS right from all these perspectives, there is very little chance of going wrong.

To enable medical device companies get all the aspects of their QMS right; GlobalCompliancePanel, a highly renowned provider of professional trainings for the areas of regulatory compliance will be organizing a two-day seminar. To enroll for this highly interesting and useful learning session, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900651SEMINAR?FDA-concepts-medical-device-companies-San-Diego-CA.

Suzanne Manz, an accomplished leader in the medical device industry, who emphasizes quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the Director of this seminar.

Concepts and characteristics of a good QMS.

Susanne will introduce participants to the Quality System Regulations and how they can be translated into a QMS that is both agile and rigorous when it comes to ensuring safe and effective products. She will give an understanding of the essential capabilities for managing an exceptional Quality System. 

Throughout the seminar, emphasis will be made on the regulatory expectations and how participants can translate these into their QMS.

The ways of structuring and optimizing their QMS will be among the core learning areas from this seminar. The starting point of all these is Management Responsibility and a commitment to quality. In discussing the concepts of management responsibility, a culture of quality, and continuous improvement; Susanne will make this learning comprehensive and well-rounded.

She will also explain the following at this seminar:

o   The tools and metrics needed for understanding the state of a QMS and ways of identifying and prioritizing opportunities for improvement

o   The four major Quality System elements that are emphasized by the FDA in their QSIT (Quality Systems Inspection Technique) inspections

o   Lessons learned from Recalls, 483s, and Warning Letters

o   Myths and challenges and how common problems can be avoided

o   Best practices that can be easily adopted.

Susanne will cover the following areas at this seminar:

o   Expectations for Medical Device Quality Management Systems

o   Regulations

o   Quality Management System Structure and Processes

o   Lessons Learned

o   Myths

o   Challenges

o   Best Practices

o   Inspection Readiness

Ensuring compliance with healthcare laws is of utmost importance for healthcare providers

Compliance with the many laws, as well as implementation of the necessary compliance initiatives are the means by which healthcare providers and entities or organizations involved in any type of healthcare transaction, especially those who bill or are involved with services payable by a CMS program, play a part in the protection of the integrity of  the CMS programs.

Developing and maintaining the necessary compliance programs that place a special emphasis on auditing and monitoring, appropriate training, receiving and responding to complaints and conducting investigations is necessary for providers, entities and organizations that bill Medicare, Medicaid or other government payor programs. Those whose compliance program fails to incorporate the necessary control processes risk inviting potential audits that could lead to civil, monetary and criminal penalties.

Understanding risks is necessary for healthcare practices

The ways by which to understand potential risks relating to their practice or organization and responding and mitigating deficiencies are all-important for healthcare organizations if they have to sustain their success and viability. This is also necessary if the organization has to avoid or neutralize the impact of negative findings by an external audit or investigative agency.

Moreover, with the many impactful changes taking place in the healthcare delivery; healthcare provider reimbursement could be affected. Quality of care and reduced costs will bring about changes into provider reimbursement for services. Healthcare providers have to understand how these changes are going to affect them.

Learning ways of implementing compliant programs

A two-day in person seminar by GlobalCompliancePanel, a highly reputable provider of professional trainings for all areas of regulatory compliance, will offer understanding on all these areas of healthcare compliance. This course, at which Gail Madison-Brown, a Registered Nurse and attorney who has spent over 25 years in the healthcare industry, and is Chief Clinical Trials Officer at UTHSCSA will be the Director,  will focus on ways by which healthcare organizations can devise means by which to stay compliant with the regulatory guidelines and laws.

To enroll for this seminar and to get a thorough understanding of how to implement practices that are compliant with regulatory requirements, just visit 

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900544SEMINAR?ensure-healthcare-compliance-Seattle-WA.

Ways of building a robust and pragmatic compliance program

Attending this seminar will help participants understand how to build a solid and practical compliance program. Gail will introduce the basic healthcare compliance infrastructure necessary to establish a comprehensive and proactive compliance program. She will then discuss current government auditing agencies and audits that are underway, as well as government agencies responsible for protecting the Medicare Trust Fund from fraud, waste and abuse.

She will teach participants the ways of identifying risks in their organizations, no matter what their size, by conducting a risk assessment and developing a work plan based upon risk and will help with the mitigation efforts. Apart from OCR audits and how to conduct their own self-assessment in preparation for an audit, as well as ways of addressing any identified deficiencies; participants will also learn how to conduct auditing and monitoring activities and what to do with findings. Ways of putting in place a complaint management system and conducting an investigation will also be discussed. The Director will also offer user friendly templates and tools, as well as numerous case scenarios to the participants, which they can use to enhance current compliance programs.

Cleaning validation should have a policy designed to meet harsh regulatory requirements and principles

Compliance with the required cleaning validation regulatory compliance guidelines set out by the regulatory authorities such as the FDA, WHO, PIC/S and EU is essential for those who work in facilities which involve cleaning.

The reason for which adherence to these regulatory guidelines is necessary is that these cleaning procedures need to establish and demonstrate verifiable standards of hygiene and safety. Quite naturally, cleaning validation regulations are built on highly rigorous, exhaustive and challenging principles.

Many approaches and requirements

Sound scientific principles and practices should be the basis for regulatory guidelines for cleaning validation. Cleaning validation, being risk based and reasonable, should consist of informed decision-making and thorough activity planning.

To comply with cleaning validation regulatory guidelines and scientific principles; very precise concepts such as how to determine the residues to be targeted, ways by which to select the right analytical and sampling methods, how to determine the appropriate limits in various pharmaceutical and biotechnology processes and knowing by what means to establish scientific rationales that are acceptable to regulatory inspectors, need to go into cleaning.

Lots of processes need to go into cleaning validation 

These concepts should ideally lead to the development of a general policy, i.e. a “Cleaning Validation Master Plan”, into which the appropriate documentation for each study needs to be performed. Awareness of the requirements for maintenance of the validated status is necessary for those in charge of the cleaning validation program. They have to also keep the regulatory requirements and the latest industry practices in mind.

Clarity on all these topics is the intent of a detailed, two-day learning session on the topic, “Regulatory Requirements and Principles for Cleaning Validation”, which is being organized by GlobalCompliancePanel, a well-known provider of regulatory compliance trainings. To participate in this seminar, simply log on to 

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900635SEMINAR?regulatory-requirements-Washington-DC. 

The Director of this learning session, Joy McElroy, Principal Consultant at Maynard Consulting Company, will clear all the doubts regarding cleaning validation and all its elements. Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification during the over 20 years of total experience she has had in the pharmaceutical and biotech industries, 12 of which have been as a consultant.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

o   Managing risks

o   Validation of processes

o   Establishing product/process specifications to QC to such specifications

o   Monitoring compliance to such specifications

Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director at this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

To enroll for this seminar, participants can log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900535SEMINAR?applied-statistics-QA-QC-Seattle-Washington.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products. 

This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry. 

Finessing the ways of using lineament analysis in geological exploration

Geological exploration has many benefits for mankind. Yet, there are a few limitations with the current set of methods being used by geologists. The full extent of technologies is yet to be harnessed.

The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process if the best possible confidence in resultant mineral resource and reserve estimates are to be achieved. 

Accurate and proper QA and QC procedures and protocols are essential to ensure that data collected and created by the mining organization is of a high level of quality and is in compliance with CIM Standards and Guidelines. Geological quality control procedures are meant to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying. The quality of the data used determines the quality of an estimate.

Learn to get Quality Assurance and Quality Control procedures and protocols right

The way to do this effectively for better results will the learning offered at a two-day in person, live seminar that GlobalCompliancePanel,  a highly reputable provider of professional trainings for regulatory compliance, will organize. More details of this seminar can be had from

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900534SEMINAR?using-lineament-analysis-Salt-Lake-City. 

The Director, Ricardo Valls, will introduce the participants to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. This methodology helps participants to concentrate their exploration efforts even over new areas with limited or nonexistent geological information, while keeping their budget in check.

The centrality of QA&QC procedures

Ricardo will explain how lineament and satellite interpretation are a way to define where to concentrate exploration efforts, as well as how to implement QA&QC procedures to guarantee the quality of the collected data. This is necessary, considering that compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets. Quality assurance is essentially the management system that operates to ensure credible results. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability.

The learning will be gleaned from a quality assurance program that the Director has implemented for the field sampling procedures. This includes collection, labeling, and shipping components. The quality control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as:

o   The adherence to written protocols; up-to-date and suitable training of personnel

o   The use of reliable laboratories with excellent QA&QC systems in place

o   The regular use of quality control (QC) samples (blanks, standard samples, and field duplicates)

o   Diligent record keeping. 

Tips for managing CRO's

The role of clinical contract research organizations (CRO's) has come into focus of late, with the burgeoning growth of the outsourced model for business. In the clinical research industry, CRO's are considered viable alternatives to expensive domestic players. This is because since it is the clinical study process that needs to be outsourced to developing countries; this can happen at a more economical rate than when insourced to clinical contractors in developed economies.

Pros and cons of managing CRO's

Undoubtedly, the biggest advantage a pharmaceutical company or any other sponsor gains by outsourcing its clinical research is that it saves humungous amounts of money. This is the most obvious no-brainer, because huge cost advantages exist between developed and developing economies.

In addition, there is also the assurance of quality delivery. A CRO is legally contracted to supply the process and results of a remote clinical trial on time with almost no use of resources from the outsourcing organization.

Of course, there are downsides in managing CRO's, as there are in any business process. CRO's that outsource their clinical research need to be in control of the whole process, right from start till finish. Unlike say, manufacturing or software, in which the business deals with nonliving products and technologies; sponsors have to constantly be on their toes in monitoring process, results and quality of their outsourced activity, which can vary with the slightest change in input.

So, what do sponsors need to do for managing CRO's?

First, the aims and objectives of the clinical research need to be very clearly spelt out. All the steps and processes involved in managing CRO's need to be mentioned very clearly in writing at the beginning of the outsourcing activity, as any ambiguity at any stage will open the way for interpretation and is likely to lead to unpleasantness

Keeping control over the process remotely is a way of managing CRO's. In a remote, virtual clinical trial, the integrity of data has to be ensured at all stages and approved, so that the next phase is cleared for starting after the previous one has been validated and approved by the sponsor. Putting these steps in place goes a long way in helping sponsors manage CRO's effectively.

Read More: https://www.linkedin.com/pulse/tips-managing-cros-ronald-gardner