Seminar Calendar of Upcoming Courses – June to July – 2017

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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 FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials

The establishment of the initial safety of a drug is the primary reason for which early clinical trials are conducted. Phase I of drug development consists of:

o  Research and drug discovery

o  Preclinical development, of which initial IND, or first in humans (also called first in man), is part

o  Clinical development, which consists of Phase I, Phase 2 and Phase 3 clinical pharmacology studies

Phase I studies are designed mainly for investigating the following qualities of an investigational drug in humans:

o  The extent to which it is safe and tolerable: (if possible, identify its Maximum Tolerated Dose (MTD)

o  Pharmacokinetics

o  Pharmacodynamics of an investigational drug in humans.

The ultimate goal of these Phase I and later studies is to ensure that the right drug is given to the right patient in the right dose, at the right time. These clinical studies are carried out to determine which dose or dosing regimen of the target drug achieves all its objectives for all the populations groups for which it is being developed.

Rationale for a small sample

Generally, these studies are carried out on a small sample of subjects of normal health. These early clinical trials normally use lower doses of the drug product. On account of this, the organization or laboratory carrying out these early stage clinical studies uses only small amounts of investigational material.

This is because of two reasons: The small sample is chosen in such a fashion that it is a representation of the whole study in relation to various parameters, and two, choosing a small sample substantially reduces the costs associated with a largescale study. It also reduces the regulatory burden during these early stages. Keeping in mind these factors, the FDA has established guidelines by which early stage investigational products can be allowed to be manufactured under less stringent GMPs.

Not meeting regulatory requirements makes the exercise futile

Without an understanding of the FDA’s guidelines for these GMPs, the whole exercise of early or Phase I studies becomes wasteful and meaningless. All along, the FDA’s guidelines have to be consistently and accurately adhered to in order to meet compliance requirements, without which the clinical trial and its results do not get approved.

What are the steps that a clinical or pharmaceutical organization need to take in order to ensure that these GMPs for Phase I clinical trials are being met? All the aspects of this topic will be covered in depth over two days of intense learning that will be imparted at a seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

Peggy Berry, the President and CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development, will be the Director of this seminar. All that is needed to gain from the rich wealth of Peggy’s experience is to register for this seminar by logging on to Good Manufacturing Practices . This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A complete explanation of the FDA’s GMP requirements

This seminar is being organized to help participants gain an understanding of the requirements for advancing drugs from research into early clinical development and the minimum FDA requirements for Phase I GMPs. She will help them learn practical applications for implementing Phase I manufacturing strategies to meet FDA requirements.

Towards this end, Peggy will discuss these topics to lay the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products on Day 1:

o  Moving a Product out of R&D

o  CMC Requirements for an IND Study

o  Good Manufacturing Practices: Basics for Beginners

o  Raw Material Management

Taking off from these topics, Peggy will focus on the topics relating to the requirements for early stage products of different types and for vendor selection and management on Day 2, which include:

o  GMPs for Phase I IND products

o  GMPs for Combination Products and 505(b)(2) Products

o  Process Validation for Early Stage GMP

o  Outsourcing Early Stage Manufacturing.

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA) . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

 

Medical device companies need to get their design controls right

Design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA, despite the regulatory agency considering this area as critical. It goes without saying that Design Controls are indispensable for ensuring the safety and effectiveness in the production of medical devices. Statistics show that a substantial percentage of all medical device recalls are due to design problems. This is despite the fact that intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase.

When Design Controls are not built strongly enough into the medical devices, these are some of the implications:

o  Design Control flaws are a reason for a significant number of recalls

Design Control issues lead to complaints and medical device reports

o  When Design Control is not properly put in place, the manufacturer can face issues related to manufacturability, like low yields and excessive scrap and rework.

The solution is getting trained on Design Control issues and understanding the ways of implementing them

Given the severity of Design Control issues, medical devices manufacturers need to address the problem with one solid solution: Understand how to locate and fix issues early on in the design process. If this is not done, the consequences can be expensive. Finding and fixing problems for medical devices that are already in production is must more expensive than doing so at an earlier stage. What is more; such a process can also make the Design Control less effective.

How do medical device companies ensure a Design Control process that is free of hassles and will serve the primary intention for which it is to be implemented? This is the teaching a two-day seminar that is being organized by GlobalCompliancePanel, a highly regarded provider of professional trainings for the regulatory compliance areas, will impart.

At this seminar, Susanne 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.  In order to gain insights into how to imbibe Design Controls into the earliest possible stages of medical device manufacture, please visit Medical device companies need to get their design controls right to register for this seminar.

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

An important session on Design Controls

The main intention of this seminar is to provide a clear and deep understanding of the nature and importance of Design Controls in medical devices, and the ways of developing Design Controls processes and tools that are compliant with the regulatory requirements. Susanne will offer these to ensure that they become a competitive strength for their organizations. With this learning, participants can learn from past issues and mend their next generations of product.

An explanation of the requirements for design controls and an understanding of how to translate them into an efficient and effective process for their organizations will be given. Susanne will begin with the history and requirements for Design Controls. The next topic she will take up in detail is the requirements and tools needed to ensure product quality, while also meeting business needs for speed to market.

Also included are exercises to help participants practice what they have learnt here theoretically. At the end of this two-day session, participants will have gained the knowledge needed to improve their design control process.

Susanne will cover the following areas at this seminar:

o  Expectations

o  Regulations and History

o  Design Control process, procedures, forms, records, files

o  Linkages to the rest of your Quality Management System

o  Lessons Learned

o  Myths

o  Challenges

o  Best Practices

o  Inspection Readiness.

The FDA’s requirements for Drug Applications and Submissions

The FDA has set out requirements by which it accepts drug applications and submissions. It accepts drug applications and submissions through two formats, the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). The NDA and the ANDA are the mediums through which the FDA eventually approves drug applications and submissions.

The NDA process

The NDA is one the two mechanisms through which the FDA accepts drug applications and submissions. This application is available with the FDA. Any sponsor of a clinical study, be it an organization or an individual, can apply for the NDA and can submit the same, when it is convinced that it has sufficient evidence that its study meets the FDA’ requirements for marketing approval.

The way to go about filing for an NDA as part of drug applications and submissions is this:

The ANDA process

The ANDA is the other method of drug applications and submissions to the FDA. Being the counterpart of the NDA; the ANDA is the application a company makes for getting a generic drug approved by the FDA for marketing. The ANDA also has to contain the same data as contained in the NDA drug applications and submissions, but is not required to be accompanied by the data of the clinical research. It is for this reason that they are called by their name.

In place of the clinical research data, the ANDA format of drug applications and submissions has to contain evidence that the product has the ability to perform the same functions of the original drug. This is called the drug’s bioequivalent value. Like in the case of the NDA, the ANDA too is allocated a reference number as part of its drug applications and submissions.

Common factors taken into consideration

In either of these methods, the primary considerations for the FDA include the following:

  • The safety and effectiveness of the drug
  • Its ability to meet its intended use
  • Its ability of its benefits to outweigh its risks
  • The appropriateness of the drug’s planned labeling and its contents
  • The ability of the methods used in the manufacturing of the drug to meet Good Manufacturing Practice (GMP)
  • The capacity of the drug to have to controls in place for maintaining its quality, purity, strength and identity

Read more : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900762SEMINAR?wordpress_seo

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

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 http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900794?linkedin-SEO .

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.