Source: https://globalcompliancepaneltraining.wordpress.com/category/fda-organized/
Timestamp: 2017-06-29 15:52:55
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FDA organized | globalcompliancepaneltraining
HomeFDA organized	FDA organized	Upcoming FDA FSMA Rules of Human and Animal Foods
May 9, 2017 GlobalCompliancePanel-Training
A Tour of the FDA, fda, fda audit, FDA Compliance, FDA organized, FDA regulatory 510(k), history of the FDA, New FDA FSMA Rules, Uncategorized	clinical research, clinical research trials, fda clinical trials, fda clinical trials regulations, HEALTHCARE, Medical, medical research studies, pharmaceutical clinical trials, regulatory green light checklist, tablet manufacturing process, what is a clinical trial	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 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.
FDA requirements on data integrity and its implementation
May 3, 2017 GlobalCompliancePanel-Training
A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, FDA Compliance, FDA organized, FDA regulatory 510(k), history of the FDA, New FDA FSMA Rules, Uncategorized	21 cfr part 11 compliance checklist, cfr21 part 11, code of federal, data integrity audit checklist, data integrity definition, fda data integrity guidance, fda warning letter data integrity, mhra data integrity, usfda audit, what is data integrity	The phrase “data integrity” seems to be everywhere. It is used in a number of places and situations, and the FDA has its own definition of the term. At its plainest, data integrity is defined as the assurance that data is complete, consistent and accurate. FDA requires this data to be attributable, legible, contemporaneously recorded, to be an original or a true copy, and to be accurate. This criterion is embodied in the acronym ALCOA.
Is just an understanding of this definition sufficient? In order to understand data integrity from the computerized systems point of view; one has to apply 21 CFR Part 11 and Annex 11 to data. Its implementation is considered difficult for a number of reasons. To apply data integrity to computer systems, one needs to understand the concept of data integrity.
Understanding is necessary in view of the FDA’s stepped up inspections
It is only this basic understanding that will help to determine what needs to be done to meet national and global data integrity requirements. This is all the more important in view of the fact that regulatory agencies such as the FDA have accelerated inspections related to data integrity, as a result of which there has been a big rise in the number of citations relating to data integrity.
When it comes to data integrity for computerized systems, the requirements set out in 21 CFR Part 11 and Annex 11 need to be kept in mind from the following perspectives:
o The background to and the way in which 21 CFR Part 11 and Annex 11 have evolved and why they are being talked about all over again
o An understanding of the full overview of Part 11 and Annex 11 and their key requirements
o Clear understanding of how the use of Risk Based Assessment will not only achieve data integrity and compliance but also bring down work considerably
o The FDA’s and other regulatory authorities’ method of inspecting computerized systems for data integrity.
A complete two-day exploration of data integrity from the FDA’s perspective
It is to familiarize IT professionals and professionals who work on data integrity that GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance will be organizing a two-day seminar.
The Director of this seminar is Angela Bazigos, who is CEO of Touchstone Technologies Silicon Valley. Angela brings over 40 years in the healthcare and life sciences industries. To gain the benefit of Angela’s experience in the industry and to discover ways of ensuring data integrity in the computer systems of a number of healthcare and life sciences disciplines, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900946SEMINAR?wordpress_SEO . This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Practical understanding of data integrity
This seminar is very hands-on and is meant to offer guidance on how to ensure data integrity in highly regulated industries. It is of relevance and importance to both beginners and experienced professionals alike. She will offer a completely detailed experience of validation and 21 CFR Part 11 compliance that a computer system needs to have.
One of the major takeaways of this seminar is the templates Angela will give to participants, which will help them build a full package for meeting data integrity for computerized systems. She will also detail the activities associated with Computer Systems Validation, exploring areas such as:
April 27, 2017May 15, 2017 GlobalCompliancePanel-Training
A Tour of the FDA, fda, FDA 21 CFR Part 11 Compliance, FDA Compliance, FDA organized, FDA regulatory 510(k), history of the FDA, New FDA FSMA Rules, Uncategorized	A Tour of the FDA, audit program, auditing courses, FDA 21 CFR Part 11, fda audit, FDA Compliance courses, fda guidelines, FDA regulatory training, FDA requirements, FDA Warning Letters, FDAs mission statement, Food and Drug Administration, Food and Drug Administration Regulations, internal audit procedure, internal audit program, internal audit risk assessment, internal audit system, medical auditing companies, safety audit	A tour of the FDA is something like a snapshot of what the FDA does. The importance of the FDA can never be understated: It regulates products from the proverbial pin to airplane in the food, medical devices, pharma and healthcare industries, which touch almost every aspect of American lives. The products that the FDA regulates account for about a trillion dollars, which make up about a quarter of all goods traded in the US.