Upcoming FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

The process of finalizing new food safety rules by the U.S. Food and Drug Administration (FDA) is underway. The accent of these upcoming FDA FSMA rules on the sanitary transportation of human and animal foods is the ways by which scientific and safe transportation and logistics involved in food transportation can be bettered. The FDA is required to establish rules for improving, auditing and enforcing new rules relating to food transportation. Congressional instructions have been issued for ensuring the establishment of these rules.

These are the aspects of food transportation that come under the ambit of these new FSMA Rules:

-       Foods not completely enclosed by a container

-       Preventing and reducing adulteration and risk

-       Training and certification of personnel for this purpose

-       Food inspection and collection of data

-       Maintaining compliance and reporting about its evidence.

Get trained on how to do this right

Since the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods apply to organizations that work in food transportation; these organizations have to ensure proper adherence to these rules. To do this, they need to first understand the rules and also know what it takes implement them. A seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance will offer this learning.

John Ryan, President, TransCert, QualityInFoodSafety, RyanSystems, is the Director of this two-day seminar. He will offer understanding and insights into the way the new Rules from the FDA apply to players involved in the transportation of human and animal foods.

The Director will also impart complete understanding of the ways by which to establish the right temperature monitoring, sanitation, container test and traceability, training and data reporting procedures and review the same. This seminar will also offer an understanding of the legal requirements of food transportation and how to develop a company plan that meets the expectations and requirements of both its customers and the FDA.

You can register for this seminar by visiting Upcoming FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion

Technological aspects of FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Dr. Ryan will offer insights into all the aspects of the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and help participants understand how to comply with them. In the course of this learning, he will cover the technological aspects of food transportation, which are gaining importance lately. These include new low cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing. Dr. Ryan will examine the close relationship these technologies have with the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods.

Dr. Ryan’s assessment of the future of transportation food safety vis-à-vis new and evolving technologies will be peppered with references to upcoming technology providers. He will provide the participants of this seminar with Internet links that lead to more detailed information on the same.

Those in food supply chain logistics and food safety and security personnel whose primary responsibilities include management, sanitation, quality and operations; will find this seminar highly useful.  It will also be useful for personnel that handle incoming and outgoing food shipments, maintaining transportation equipment and tools, and purchasing or selling.

Dr. Ryan has the following agenda for this seminar:

o   Review of the FDA's proposed rules on the sanitary transportation of human and animal foods

o   Review of other international transportation food safety guidance and laws

o   The meaning of adulteration

o   Review of Standards

• Management
• Sanitation
• Hazard analysis risk-based preventive controls
• Traceability and temperature monitoring
• Training

o  GAP analysis

o  Learning what happens during cold chain food transportation through all processes

• Farms
• Air
• Ship
• Truck
• Trays and Bins

o  Data, logs, forms and electronic record keeping

o  Shipment cargo theft, security and recall

o  Issues facing food importers and those buying from them

o  Return on investment (ROI) and marketing advantages

o  Future technologies (trans-oceanic, satellite, etc.)

o  Establishing an initial plan to implement your auditable system

• Choosing which standards apply to your company
• Flowcharting your process
• Determining when and how you will perform a GAP analysis
• Listing new procedures for your operation
• Selecting and assigning key personnel.

Design of Experiments (DoE) for Process Development and Validation

Design of Experiments (DoE) is a very important process development and validation component in several kinds of industries. DoE for process development and validation involves carrying out a number of tests recurrently and steadily over a period of time. Its responses are then observed.

DoE is important for process development and validation as it offers an understanding of the predictability and reproducibility of an experiment. Fundamentally, Design of Experiments for process development and validation seeks to rule out fluke or chance in the methods needed for bringing about control for a product.

DoE in medical devices

In the area of medical devices, guidelines for Design of Experiments for process development and validation are set out in the Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers. This document offers guidance in the area of Design of Experiments for process development and validation by suggesting the exact areas in which design of experiments should be applied during Process Validation.

The GHTF guidance also suggests the use of both screening and response surface designs during Operational Qualification. It further requires Design of Experiments for process development and validation to be used during various phases of design controls. These include:

o  Design and development planning

o  Design verification

o  Design validation

o  Design transfer

o  Design changes.

Get a full understanding of Design of Experiments for process development and validation

The ways of approaching Design of Experiments for process development and validation will be topic of a two-day seminar that is being organized by GlobalCompliancePanel, a highly respected provider of professional trainings for the areas of regulatory compliance.

Jim Wisnowski, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director at this seminar. In order to gain a full understanding of the principles and application of Design of Experiments for process development and validation; please register for this seminar by visiting Design of Experiments (DoE) for Process Development and Validation

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

All about Design of Experiments for process development and validation

This seminar will offer total and all-round understanding of all the aspects of Design of Experiments for process development and validation.

Process development studies need to be completed before a process control plan is developed as part of an overall risk management strategy. These process development studies help gain knowledge and understanding about the impact of variation in process parameters on the variation in the product quality characteristics of the product.

An explanation of the methods used

The methodology of Design of Experiments for process development and validation offers a means for identifying process parameters, which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes.

Design of Experiments for process development and validation uses screening designs such as 2k factorial and D-optimal designs to determine critical process parameters. Design of Experiments for process development and validation use response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs for fashioning the functional relationship between those critical process parameters and the critical quality attributes.

A primer on statistical analysis

This seminar on Design of Experiments for process development and validation will present a primer on statistical analysis, during which it will focus on the methods required for analysis of designed experiments. Jim will then move on to the steps to a proper DoE, during the process of which he will demonstrate the nature and uses of important risk management tools such as Ishikawa and FMEA, which can be used pre and post DOE studies.

The Director will also teach how to generate and analyze multiple screening and response surface designs, and why and how each are used. After teaching participants how to present the results, Jim will explain how to update the risk management tools using the results of the studies.

This session on Design of Experiments for process development and validation will cover the following areas:

o  Identify critical quality attributes (CQAs) that will be used as responses in your designs

o  Utilize risk management tools to identify and prioritize potential critical process parameters

o  Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs) using both screening and response surface designs

o  Be able to design and analyze screening designs including a factorial, fractional factorial, and D-optimal design

o  Understand the need for adding center points to a design

o  Be able to design and analyze response surface designs including central composite designs (CCDs), Box-Behnken designs, and I-optimal designs

o  Present results of DOE studies

o  Use systematic understanding from DOE studies to update the control plan that is part of the overall risk management plan.

Seminar Calendar of Upcoming Courses - June to July - 2017

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP's, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com  
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

“Understanding the practical application of statistics?”

The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:
o  Setting validation criteria and specifications
o  Performing Measurement Systems Analysis (MSA)
o  Conducting stability analysis
o  Using Design of Experiment (DOE) for process development and validation
o  Developing process control charts
o  Determining process capability indices.
The Quality System Regulation (QSR) for medical devices states that manufacturers should take steps, where appropriate, for establishing and maintaining procedures with which to identify valid statistical techniques needed to establish, control, and verify that the process capability and product characteristics are acceptable.
Methods are specified in 21 CFR and guidance documents

Both 21 CFR and guidance documents emphasize the need for statistical methods from discovery through product discontinuation. While 21 CFR specifies the suitable statistical procedures needed to establish both in-process and final specifications; the guidance documents require applying statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring that the manufacturing process is in a state of control and is capable.
Even though many statistical methods may be applied to fulfil this part of the QSR; there exist a few commonly accepted methods that all companies can and preferably should use for:
o  Developing acceptance criteria
o  Ensuring accurate and precise measurement systems
o  Fully characterizing manufacturing processes
o  Monitoring and controlling process results, and
o  Selecting an appropriate number of samples.
Learn the dynamics of statistical methods
The nitty gritty of application of statistical methods will be the teaching a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be offering. At this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP; will be the Director.
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. To understand the areas of implementation of statistical methods that comply with the requirements set out in CFR 21 and guidance documents, please enroll for this session by visiting "Understanding the practical application of statistics"
A full description of statistical processes

This course provides instruction on the statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries. The Director will explain the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building need to be applied. Upon establishment of competence in each of these areas; he will present the way these need to be applied in an industry-specific manner.
During the course of these two days, Heath will cover the following areas:
·        Describe and analyze the distribution of data
·        Develop summary statistics
·        Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions
·        Describe the relationship between and among two or more factors or responses
·        Understand issues related to sampling and calculate appropriate sample sizes
·        Use statistical intervals to setting specifications/develop acceptance criteria
·        Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility
·        Ensure your process is in (statistical) control and capable.

Knowledge of employment laws is absolutely crucial for organizations

As the new presidential administration settles in in the US, employment law could be an area in which to expect tremendous changes. While what the new president’s open and vocal support for protection of the domestic workforce will mean to employment laws may take some to fully unfold and unravel; a look at the evolution of the important employment laws and the changes taking place into them of late should serve as some kind of indication of what is to come.

One thing that is certain is that 2017 is going to be an uncertain year for employment law. Changes that could make a big difference to many organizations can be expected to be rolled out by the new administration. A fact of additional significance to employers is that there has been a steady increase in the number of employment lawsuits of late.

In 2016, enforcement actions by the Equal Employment Opportunity Commission (EEOC) gave the agency a staggering amount of between $350 and $400 million in monetary damages. This has been the highest recovery ever from the time it was created in 1965. Not surprisingly, the number of claims filed by employees with this Commission has reached record levels in the last three years.

Lack of knowledge of the law is at the root of lawsuits

Most of these lawsuits are a result of the lack of understanding that employers have of workplace issues. Companies in which the managements are ignorant about these issues or choose to overlook them end up facing a host of issues such as:

o  Discrimination suits

o  Employee turnover

o  Unplanned expenses

o  Settlements

o  Litigation

o  Lawyer fees

o  Low morale on the part of employees

o  A bad beating to their image.

The means to avoiding such scenarios is for organizations to grasp the enormity of these actions. If they have to avoid litigation and other reputation-damaging actions; they need to be aware of the employment law regulations and be compliant with these. They also need to be clear in their understanding of what to expect from the new administration.

A session to help get thorough understanding of employment laws

It is to impart understanding of these topics that a GlobalCompliancePanel, a leading global name in the field of regulatory compliance trainings, will be organizing a two-day seminar. Vanessa G. Nelson, who is founder and President of award-winning Expert Human Resources, which she founded to help companies maintain employment law compliance, avoid workplace litigation, maximize human capital, create great teams, and reduce costs, will be the Director of this course.

To get complete understanding of all the crucial aspects of human resource law, the ways by which to comply with employment laws and regulations and the potential impact on employment law from the actions of the new administration; please register for this seminar by visiting Knowledge of employment laws is absolutely crucial for organizations .

A clear roadmap to advanced human resources and employment law

The essence of this seminar is the roadmap to advanced human resources and employment law that Vanessa will lay out for the participants. Given the factors described above; this understanding is critical, no matter what the size of the organization. The right grasp of employment laws and HR practices is essential if organizations have to become successful at their business. The Director of this seminar will simplify the complex nature and the huge number and variety of employment laws and the issues relating to them.

Participants will able to learn the ways of dealing with often muddling human resource situations and how to apply relevant employment laws correctly to avoid problems. A look at the cost of litigation will perhaps give some idea about the need for employers to remain compliant with the employment laws: Without lawyer fees, a lawsuit costs $165,000 on average. The cost of a case that goes to trial is exorbitant: It is in excess of a million dollars, and comes with the strong prospect of imprisonment for noncompliance with employment.