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:

  • Managing risks
  • Validation of processes
  • Establishing product/process specifications to QC to such specifications
  • Monitoring compliance to such specifications

risk

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”.

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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=900537SEMINAR.

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.

medical-device

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.

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John will cover the following areas at this seminar:

  • FDA, ISO 9001/13485, and MDD requirements related to statistical methods
  • How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
  • Design Control processes (verification, validation, risk management, design input)
  • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
  • Manufacturing processes (process validation, equipment qualification).

Application of concepts and theories of clinical research

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed.

There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requirements but also that it is conducted in an ethical manner, coming with adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research.

Guidelines lack clarity

However, the challenge that this position presents is that the guidelines –which also provide interpretation of the regulations –are not always as clear as they might appear upon first reading them.

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will impart understanding on all these grey areas of human subjects. It will clarify on these regulations. To enroll for this highly educative session, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900671SEMINAR.

The Director of this seminar is the highly regarded expert on the subject, Sarah Fowler-Dixon, Education Specialist and instructor with Washington University School of Medicine. Sarah has developed a comprehensive education program for human subject research which has served as a model for other institutions.

Ways of applying concepts and theories

This two-day seminar will provide the foundation for the application, concepts and theories of clinical research.

hipaa-compliance

The speaker will not only provide a refresher of the regulations; she will also provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participant signing an outdated consent document, etc.) when conducting human subjects.

Outcomes of the seminar

The learning acquired over these two days will help attendees learn about the historical evolution of research, and current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. This session will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. It will also discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.

 

Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA’s recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

Although these new guidelines appear to remove the need to follow GMPs for Phase I products; the same still exists in the Food, Drug, and Cosmetic Act. As a result, the need for GMP requirements for Phase I products has not been done away with; rather, it has been altered. Now, the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

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Get trained to understand these aspects

GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar to help Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control get a grasp of these aspects. To enroll for this highly valuable training, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900695SEMINAR?GMP-regulatory-expectations-San-Diego. Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director of this webinar.

Advice on the GMP guidance document

This presentation, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion, will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. In one source, it will present the regulations and guidelines that apply to early phase products. In some cases these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Steven will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

clinicaltrials

This course is very useful for any pharmaceutical personnel who must deal with products both in early and later phases of development, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar.

It will cover the following areas:

  • Very Early Stages
  • GLP requirements
  • Early Pre-IND Studies
  • Meetings and Preparing for the IND
  • GMPs for Phase 1 IND products
  • Requirements for Phase 2 INDs
  • Preparing for IND Meetings

Think like the FDA to get compliance right

If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right.

FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, prosecutions, or recalls or consent decrees if serious violations are discovered at inspections. How does one inculcate the FDA line of thinking on compliance? Organizations need to first get an understanding of what the FDA looks for and keep these in compliance.

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The core of all compliance activity is possession and demonstration of control over the company’s Quality System. When an organization shows this using the subsystem approach; it gives the FDA fewer opportunities to cite minor deviations from the quality system regulation. This is the basis to avoid being cited for more serious systemic deviations from the regulation.

Gaining understanding through training

Proper training on these aspects goes a long way in helping organizations steer clear of issues that give an opportunity for the FDA to take these actions. A two-day seminar from GlobalCompliancePanel, a well-known provider of professional trainings in the regulatory compliance area, will be of immense value in helping professionals get a clear idea of how to get their compliance requirements right.

Just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900523 to learn about the ways of getting into the FDA’s line of thinking on compliance. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The Director of this seminar, David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services, will offer a clear understanding of all the critical components of dealing with an FDA inspection, such as:

FDA History, Inspectional Strategy and Techniques

  • SOPs
  • Training
  • Audits
  • Managing the Inspection and State of Readiness
  • Responding to FDA Inspectional Observations (483s)/Warning Letters
  • Mock Inspections
  • Compliance Program 7356.002, Drug Manufacturing Inspections and other Compliance Programs Device Manufacturing Inspections
  • IOM (Investigations Operations Manual)
  • RPM (Regulatory Procedures Manual)
  • Field Management Directives
  • Inspection Technical Guides and official documents used as reference material for investigators and other FDA personnel

Warning Letter and Notice of Violation Responses/Communicating with FDA

  • Strategy and Remediation Implementation
  • Drafting
  • Liaison with FDA to ensure Close-out
  • Effective Responses

State of Readiness/Practice/Mock Inspections

  • Prepare for “real” inspections by being ready and not caught off guard
  • Practice Sessions and Dress Rehearsals on Day Two

 

Application of concepts and theories of clinical research

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed.

There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requirements but also that it is conducted in an ethical manner, coming with adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research.

hippa

Guidelines lack clarity

However, the challenge that this position presents is that the guidelines –which also provide interpretation of the regulations –are not always as clear as they might appear upon first reading them.

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will impart understanding on all these grey areas of human subjects. It will clarify on these regulations.

The Director of this seminar is the highly regarded expert on the subject, Sarah Fowler-Dixon, Education Specialist and instructor with Washington University School of Medicine. Sarah has developed a comprehensive education program for human subject research which has served as a model for other institutions. To enroll for this highly educative session, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900669SEMINAR?human-subjects-research-seminar-San-Diego-CA.

Ways of applying concepts and theories

This two-day seminar will provide the foundation for the application, concepts and theories of clinical research.

The speaker will not only provide a refresher of the regulations; she will also provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participant signing an outdated consent document, etc.) when conducting human subjects.

Outcomes of the seminar

The learning acquired over these two days will help attendees learn about the historical evolution of research, and current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. This session will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. It will also discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.

The FDA’s import rules get tougher for 2016. It is time to get familiarized with them.

The FDA has, in association with the Customs and Border Patrol Service (CBP), become more and more stringent of late with its insistence on the adherence to procedures and submission of information. Noncompliance with the FDA’s requirement could invite serious actions and severe penalties.

The FDA and the CBP have become so strict of late in their function that they could delay, detain or refuse shipment of firms that fail to properly implement the two agencies’ import and export program requirements. The legal and prior notice information requirements have to be complied with very strictly.

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New rules for 2016

For 2016, a new layer of stringency has been added, what with the agencies demanding adherence to the Automated Commercial Environment (ACE) entry filing system for importers that enter American shores. Some of the consequences of not adhering to the ACE:

  • Any importer who fails to do this can have its shipment barred from entry
  • Such an importer could also face a monetary penalty of $10,000 for an offence
  • The ACE empowers the FDA to stop a ship even before it is loaded
  • The CBP can fine three times the value of the shipment if the FDA decides that the importer should bring the products back to the port of entry after it has received a release, but cannot find the product that has already been sold.

Understanding the rules for import

Are you an importer who faces issues with the FDA’s import rules? Do the new rules cause alarm in you? Are you looking for expert training on how to handle this aspect of the FDA? A two-day, in person seminar from GlobalCompliancePanel, a leading provider of professional trainings for the FDA-regulated industries, is the solution.

The Director of this seminar, Casper Uldriks, who has been an ex-FDA expert and a former Associate Center Director of CDRH, brings over three decades in handling all aspects of the FDA. This seminar, details of which can be had from http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900459SEMINAR, is the ideal leaning for importers who are muddled with the new rules from the FDA.

Uldriks will cover the following important areas during this session:

  • FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation
  • Import Delays Import Alerts Detention Refusals
  • Foreign Inspections FDA 483 – Inspectional Observations
  • FDA Warning Letters and Automatic detention
  • Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical
  • FDA Export Program Special Import Issues

 

Contact Information:

http://www.globalcompliancepanel.com/

+1-800-447-9407

Sanitary transportation of human and animal foods needs to comply with new FDA FSMA rules

That the issue of sanitary transportation of human and animal foods is accorded a high degree of importance by the FDA is evident by the fact that the FDA is bound by the US Congress-legislated Food Safety Modernization Act (FSMA) rules, which relate to this subject.

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At its core, the FSMA seeks to mandate the FDA to establish rules that help in improving, auditing and enforcing food transportation rules from time to time. In doing so, it covers all the major aspects of food transportation, which include:

  • Food items not completely covered by a container
  • Preventing and reducing the adulteration and risk in the food
  • Training and certification of personnel who work in these areas
  • Collection and inspection of data
  • Following maintenance and reporting procedures that lead to evidence of compliance.

New, comprehensive rules from time to time

The FSMA keeps getting updated from time to time whenever the need for it arises. In addition, the new FSMA rules also cover aspects relating to the food industry, such as how to implement low cost GPS enabled traceability and temperature monitoring technology, ways of using EPA-approved container sanitizers, how to understand and implement washout technologies, the ways of understanding and handling temperature maintenance equipment, and the optimal ways of testing food residue and bio-contaminants.

fda transport

Considering that the FDA requires total adherence to the FSMA rules from personnel in the food transportation industry, and also keeping in view the fact that these rules keep getting updated from time to time; there is a need for those involved in any aspect of this industry to keep themselves abreast of the latest FDA aspects.

It is to facilitate this understanding that GlobalCompliancePanel, a reputable provider of professional trainings for the regulatory compliance industry, will organize a seminar. To get more details of this seminar, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900661SEMINAR

This two-day, in person live seminar will have John Ryan, who is President of TransCert, QualityInFoodSafety, and RyanSystems, as the Director. John Ryan will familiarize participants with all the aspects of the FDA’s FSMA rules, the ways in which they need to be understood, as well as how they need to be implemented.

John Ryan will discuss upcoming technology providers and will provide Internet links to the participants, which will have detailed information on these. In addition, he will also offer his insights into the future of transportation food safety, given the advent of new and evolving technologies.

Contact Information:

http://www.globalcompliancepanel.com/

+1-800-447-9407