Dietary supplement
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Understand and learn to apply FDA regulations for dietary supplements and to market them successfully in the U.S. while avoiding regulatory problems.
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Dietary Supplement Health and Education Act
DIETARY SUPPLEMENT
The purpose of dietary supplements, is to enhance or supplement the diet. Even though a product is marketed as a dietary supplement, it is still considered a medicine to the extent that it is meant to treat, diagnose, cure, or prevent diseases.
Tablets, capsules, soft gels, powders, bars, gummies, and liquid supplements are just a few of the many different forms that supplements can take.
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FDA Role
Companies can often introduce a dietary supplement to the market without notifying FDA.
FDA’s role in regulating dietary supplements primarily begins after products enter the marketplace.
If a product is found to be unsafe or not otherwise in compliance with the law, FDA can work with the company to bring the product into compliance or possibly remove it from the market.
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FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods (edible fruits and vegetables) and drug products.
Role of DSHEA
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.
That means that these firms are responsible for evaluating the safety and labelling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by DSHEA and FDA regulations.
FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market
The Dietary Supplement Health and Education Act of 1994 was enacted to prohibit
Dietary supplement manufacturers and distributors from making false claims (such as "natural" and "therapeutic," on supplement labels)
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Aim of these act:
To make dietary supplements safer by forbidding manufacturers and distributors from producing and selling mislabelled or adulterated products.
Act requires that the manufacturer of the dietary supplement ensures their product meets DSHEA and FDA regulations.
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Dietary Supplement Health and Education Act
DIETARY SUPPLEMENT
The purpose of dietary supplements, is to enhance or supplement the diet. Even though a product is marketed as a dietary supplement, it is still considered a medicine to the extent that it is meant to treat, diagnose, cure, or prevent diseases.
Tablets, capsules, soft gels, powders, bars, gummies, and liquid supplements are just a few of the many different forms that supplements can take.
It is a product that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid.
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FDA Role
Companies can often introduce a dietary supplement to the market without notifying FDA.
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Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.
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Definitions
Safety of Dietary Supplements and Burden of Proof on FDA
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As defined by Congress in the Dietary Supplement Health and Education Act, which became
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other botanicals; amino
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-- is intended to be taken by mouth as a pill, capsule,
tablet, or liquid; and
-- is labeled on
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How to Prevent and Respond to Harassment?
Review and understand company harassment policy
Comply with Title VII of the Civil Rights Act, which prohibits harassment and discrimination
Know how and when to respond to harassment issues
Report harassment immediately
Information security threats
What is Information Security?
Information security means that the confidentiality, integrity and availability of information assets is maintained.
Confidentiality: This means that information is only used by people who are authorized to access it.
Integrity: It ensures that information remains intact and unaltered. Any changes to the information through malicious action, natural disaster, or even a simple innocent mistake are tracked.
Availability: This means that the information is accessible when authorized users need it.
Information Security Threats:
Most common types of information security threats are:
Theft of confidential information by hacking
System sabotage by hackers
Phishing and other social engineering attacks
Virus, spyware and malware
Social Media-the fraud threat
Theft of Confidential Information:
One of the major threat to information security is the theft of confidential data by hacking. This includes theft of employee information or theft of trade secrets and other intellectual property (IP).
Theft of Employee Information
Employee information includes credit card information, corporate credit card information, social security number , address, etc. It also includes theft of healthcare records as they contain personal information such date of birth, address, and name of relatives.
Theft of Trade Secrets and other Intellectual Property (IP)
Technology from various verticals including IT, aerospace, and telecommunications are constantly stolen by outsiders or insiders (industrial espionage). China is a growing offender as it continues to advance in technology relying on theft of international trade secrets and IP.
Piracy/copyright infringement.
Corporate business strategies including marketing strategies, product introduction strategies.
System Sabotage:
What is system sabotage?
Planting malware on networks of target organization and generating an enormous amount of transaction activity resulting in malfunction or crash of the system.
Who would perpetrate it?
System sabotage is usually committed by disgruntled ex-employees and by remote cyber-attackers for no particular reason.
The most sensational case of system sabotage: One of the recent examples is the sabotage of Sony PlayStation.
Phishing:
To obtain confidential data about individuals-customers, clients, employees or vendors that can be used to commit various types of identity fraud such as:
Opening bank accounts in victim’s name
Applying for loans in victim’s name
Applying for credit cards in victim’s name
Obtaining medical services in victims name (e-death)
Other kind of more sophisticated social engineering attacks include spear-phishing.
Spear-phishing targets specific individuals such as AP manger, controller, senior accountant to gain access to corporate bank accounts and transfer funds abroad.
Other threats include:
Smishing: Phishing via SMS (texting)
Vishing: Phishing via voice (phone)
Mobile hackin
I 9 compliance- how to avoid errors
This guide details common mistakes made by employees in Section 1 and by employers in Section 2 and Section 3 of the Form I-9 and best practices for avoiding such errors.
Understanding 21 cfr part 11
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
Flsa what you need to know
What does FLSA do?
Fair Labor Standards Act (FLSA) :
Sets standards for minimum wage and overtime pay
Establishes record keeping standards
Prescribes child labor standards
FLSA does not regulate:
vacation, holiday, severance, or sick pay
meal or rest periods, holidays off, or vacations
premium pay for weekend or holiday work
pay raises or fringe benefits
discharge, termination, or final payment procedures
What are Basic Provisions of FLSA?
Minimum Wage and Overtime Pay Requirements
Record Keeping Requirements
Child Labor Restrictions
Who is Covered Under FLSA?
FLSA offers two types of coverage:
Enterprise coverage
Enterprises with:
At least two employees
At least $500,000 a year in business
Individual coverage
Workers who are engaged in:
Interstate commerce
Production of goods for commerce
Closely related process or occupation directly essential to such production (CRADE)
Domestic service
FLSA Exemptions
The FLSA provides an exemption from overtime pay for following employees:
Executive
Administrative
Professional
Outside sales employees
Computer employees
Highly Compensated Employees
Common FLSA Violations
Some common FLSA violations include:
misclassification of employees as exempt
improper payment/no payment for break time, training time, on-call time and travel time
inappropriately providing compensatory time off
inaccurate records
Want to learn more about FLSA, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links:
Fair Labor Standards Act: Are Your Employees Classified Correctly?
The In's and Out's of FLSA
How to Conduct FLSA Classification Self-Audit
Avoiding Costly Wage and Hour Problems
How to Pay Overtime Correctly under FLSA
Handling Supplemental Pay Under the FLSA
For more Details visit us at:http://www.complianceonline.com/classifying-employees-under-flsa-webinar-training-703602-prdw?channel=flsappt
FLSA Exemptions: How to Identify Exempt Employees
What is FLSA?
Fair Labor Standards Act (FLSA) :
Sets standards for minimum wage and overtime pay.
Establishes record keeping standards.
Prescribes child labor standards.
FLSA does not regulate:
vacation, holiday, severance, or sick pay.
meal or rest periods, holidays off, or vacations.
premium pay for weekend or holiday work.
pay raises or fringe benefits.
discharge, termination, or final payment procedures.
Exempt and Non-exempt Employees
Exempt employees- Employees who meet one of the FLSA exemption tests and who are paid on fixed salary basis, not entitled to overtime.
Non-exempt employees- Employees who do not meet any of the FLSA exemption tests and are paid on hourly basis and are covered by wage and hour laws regarding minimum wage, overtime pay and hours worked.
Test for Exemption
To qualify for exemption, employees must meet certain tests regarding their:
Salary Level:
minimum salary level required for exemption is $455 per week
Job Duties- Categories of Exemption:
Executive Employees
Administrative Employees
Professional Employees
Outside Sales Employees
Computer Employees
Independent Contractors
FLSA does not cover independent contractors. Therefore, its important to learn to distinguish between an independent contractor and an employee.
The Supreme Court considers the following factors significant in determining an employee’s role versus that of an independent contractor:
the extent to which the worker's services are an integral part of the employer's business.
the permanency of the relationship.
the amount of the worker's investment in facilities and equipment.
the nature and degree of control by the principal.
the worker's opportunities for profit and loss.
the level of skill required in performing the job and the amount of initiative, judgment, or foresight in open market competition with others required for the success of the enterprise.
Want to learn more about FLSA, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links:
Fair Labor Standards Act: Are Your Employees Classified Correctly?
The In's and Out's of FLSA
How to Conduct FLSA Classification Self-Audit
Avoiding Costly Wage and Hour Problems
How to Pay Overtime Correctly under FLSA
Handling Supplemental Pay Under the FLSA
For more Details Visit us at:http://www.complianceonline.com/classifying-employees-under-flsa-webinar-training-703602-prdw?channel=flsappt
Export contols basics
This quick reference guide discusses what are export controls, why do we need them and how they are carried out.
Method Validation: What Are Its Key Parameters
What is Validation?
Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use-Guidance for Industry
Validation is a process-risk will determine the effort
High Risk:Total validation
Moderate Risk:Testing,Documentation
Low Risk:Testing the change
Accuracy
ICH defines accuracy of an analytical procedure as the closeness of agreement between the conventional true value or an accepted reference value and the value found.
% Accuracy = Experimental- True Value * 100
True Value
Precision
Precision of analytical procedure is defined as closeness of agreement in values between a series of measurements. As per ICH, precision is considered at three different levels:
Repeatability or intra—assay precision: precision data are obtained by repeatedly analyzing, in one lab on one day, aliquots of a homogeneous sample.
Intermediate precision: precision obtained when the assay is performed by multiple analysts, multiple instruments, and multiple days in one lab.
Reproducibility: precision between laboratories.
Specificity
Specificity is the ability of the method to accurately measure the analyte response in the presence of all potential sample components.
It is very important in the analysis of complex mixtures by GC, HPLC, AA, ICP, etc.
Limit of Detection (LOD)
Limit of Detection (LOD) is the lowest amount of analyte in a sample which can be reliably detected but not necessarily accurately or precisely measured.
Signal/Noise = 2 to 3
Limit of Quantitation (LOQ)
Limit of Quantitation (LOQ) is the lowest amount of an analyte that can be quantitatively determined with suitable precision and accuracy.
Signal/Noise = 10 to 20
Linearity and Range
Linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample.
Range: Interval from the upper to the lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity
Must cover 80-120% of product claims
Usually evaluated from the same data set as linearity, precision, accuracy
Want to learn more about analytical method validation, FDA requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links:
ICH, FDA and USP Requirements for Method Validation
How to Validate Analytical Methods and Procedures
Validation of Analytical Methods and Procedures
Eliminate the Confusion - Analytical Method Qualification and Validation
Lifecycle Approach to Analytical Methods with QbD Elements
Analytical Instrument Qualification and System Validation
Lifecycle Approach to Analytical Methods for Drug Products
For details vis
A Step-by-Step Guide for Method Validation
What is Validation?
Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use-Guidance for Industry
Validation is a process-risk will determine the effort
High Risk:Total validation
Moderate Risk:Testing,Documentation
Low Risk:Testing the change
Validation of Analytical Methods-Key Steps
Preparation
Experimentation
Transfering Method
Documentation
Step 1- Preparation
Develop validation project plan
Define purpose/scope of method (performance criteria)
Define and verify performance of equipment
Qualify/validate materials
Qualify/train operator
Step 2- Experimentation
Perform validation experiments- may have to change either equipment or limits
Develop SOPs for executing the method in routine
Define type and frequency of system suitability tests and/or analytical quality control (AQC) checks
Define change control procedure
Document validation experiments and results
Step 3- Transferring Methods to Routine Laboratories
Designate project owner
Develop procedure on how to use method
Develop system suitability tests (test procedure, frequency, acceptance criteria)
Define transfer tests and acceptance criteria in the routine
Train routine lab analyst in development lab
Repeat 2 critical method validation tests in routine lab
Analyze at least three samples in development and routine lab
Analyst in routine lab should give frequent feedback
Step 4- Documentation for the FDA
Validation report and supporting documentation:
Objective, scope
Methodology
Materials
Equipment
Validation data
Supporting documentation (chromatograms, spectra)
Transfer to routine protocol
Reference to SOP
Want to learn more about analytical method validation, FDA and ICH requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links:
ICH, FDA and USP Requirements for Method Validation
How to Validate Analytical Methods and Procedures
Validation of Analytical Methods and Procedures
Eliminate the Confusion - Analytical Method Qualification and Validation
Lifecycle Approach to Analytical Methods with QbD Elements
Analytical Instrument Qualification and System Validation
Lifecycle Approach to Analytical Methods for Drug Products
For more details:http://www.complianceonline.com/validation-of-analytical-methods-and-procedures-webinar-training-701615-prdw?channel=valppt
Complying with HIPAA Security Rule
What is HIPAA?
HIPAA: Health Insurance Portability and Accountability Act
It was passed by Congress in 1996
It includes requirements for:
Transfer and continuation of health insurance coverage for millions of American workers and their families when they change or lose their jobs
Reducing healthcare fraud and waste
The protection and confidential handling of protected health information
HIPAA Security Rule
Establishes national standards to protect individuals’ electronic personal health information that is created, received, used, or maintained by a covered entity.
Requires appropriate safeguards to ensure the confidentiality, integrity, and security of electronic protected health information.
Safeguards include:
Administrative
Physical
Technical
Administrative Safeguards
HIPAA security rule requires covered entities to implement the following administrative safeguards:
Security Management Process
Security Personnel
Information Access Management
Workforce Training
Evaluation
Physical Safeguards
The security rule requires covered entities to implement physical safeguards such as:
Facility Access and Control
Access can be restricted through use of access cards, biometric scanners, keys, pass codes and so on
Workstation and Device Security
Develop and implement policies for workstation and device security
Implement unique password/user ids for each user
Proper user logs and records should be maintained
Technical Safeguards
The security rule requires a covered entity to implement technical safeguards such as:
Access Controls
Audit Controls
Integrity Controls
Transmission Security
Want to learn more about HIPAA, HIPAA Privacy and Security Rule, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links:
How to examine security policies, practices, and risk issues to comply with HIPAA
How to use social media and texting without breaking HIPAA rules
How to Conduct risk analysis to comply with HIPAA
HIPAA/HITECH Assessment for Healthcare Business Associates
How to comply with HIPAA Omnibus Rule
Understanding new rules and responsibilities of Privacy Officer under HIPAA
HIPAA Security and Breach Rule Compliance
For more details Visit us at:http://www.complianceonline.com/the-new-hipaa-audit-program-focus-webinar-training-703180-prdw?channel=ppt-slideshare
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i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
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The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
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3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
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ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdf
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Physiology of Chemical Sensation of smell.pdf
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
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2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
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Dietary supplement
- 1. Dietary Supplements in the U.S. Staying Alert as a Consumer
- 2. The Figures That Count Dietary supplements are a $23.7 billion industry in the United States. Over 70 percent of the U.S. population has tried at least one dietary supplement. In the past 6 years, FDA has identified over 400 dietary supplement products that were illegally manufactured, misbranded, or falsely labeled.
- 3. FDA and DSHEA Join Hands to Help Regulate the Industry
- 4. The Dietary Supplements Health and Education Act - 1994 DSHEA defines the term "dietary supplement" to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.
- 5. Regulatory Hurdles Federal law does not require dietary supplement manufacturers to seek approvals before production nor before marketing the products. Product advertising too comes under the jurisdiction of the Federal Trade Commission. The products have to reach the marketplace before they fall within the FDA’s perimeter. DSHEA does not set limit levels for vitamins and minerals that can be incorporated in a pill. FDA too has but a limited capacity to monitor adverse reactions from these supplements.
- 6. FDA 5 elements to be present in dietary supplement labels Statement of identity - name of the dietary supplement Net quantity of contents statement - amount of the dietary supplement Nutrition labelling Ingredient list Name and place of business of the manufacturer, packer, or distributor
- 7. Stay Informed, Stay safe www.complianceonline.com/fda-regulatory-compliance-training FDA Safety Alerts and Recalls Page: FDA Safety Alerts and Recalls Forum to Report Adverse Effects: Adverse Events