Complying With FLSA Requirements

The Fair Labor Standards Act (FLSA) of 1938 is key piece of compensation legislation. Although FLSA has been around for a long time, it is the most frequently violated employment law.  Employers misclassify employees as exempt or fail to calculate working time accurately. Misclassifications can result in severe back pay issues. Calculating overtime incorrectly can often result in overpayments or underpayments. Violations can not only hurt companies financially, but damage reputations as well.

FLSA cases have hit a new record high and continue to rise. A record breaking 8,126 FLSA suits were filed in federal courts in the last year. All in all, there has been an increase of over 400% since the year 2000. Employers have to be conversant with the intricacies of the law to avoid lawsuits. This white paper discusses what FLSA, its requirements and common FLSA pitfalls too avoid.

<<CLICK HERE>>

Dos and Don'ts of responding to Unsoliciated offlabel requests

• Be specific, truthful, unbiased and scientific
• Avoid Public responses
• Keep private response specific to the question
• Make sure the persons responding on behalf of you are medical or scientific personnel
• Make sure sales and marketing personnel are not involved at all even in training and awareness
• Makes sure you are keeping record of all the responses.

Interesting facts

Q  - Is News release about an investigator-lead IND study an off-label promotion?

Ans - Yes and No both. If it is just facts then it is no. But if it contains what you wanted to do with it and what is the derivative product out of it then yes.

Q - Sales people re-twitting a posting about benefits of the product off-label promotion or not ?

Ans - Yes, it should be discouraged.

Q - A consumer forum posting saying negative about our product. What is best way to respond?
Ans - do not necessarily have to respond but if you wanted to respond be more detailed.

Q - Is it ok to post clinical trial information on new uses of our product on clinicaltrials.gov?

Ans - Yes you should. Post on protocols etc and anything important for your products.

The Bank Secrecy Act – What It Enforces ? Best Practices how to comply ?

In 1970, the Currency and Foreign Transactions Reporting Act was passed by US Congress. It is commonly known as the Bank Secrecy Act or BSA. The Act requires US financial institutions to assist US government agencies in detecting and preventing money laundering.

Specifically, the BSA requires financial institutions to:

·         Keep records of cash purchases of negotiable instruments,

·         File reports of cash transactions exceeding $10,000 (daily aggregate amount), and

·         Report suspicious activity that might signify money laundering, tax evasion, or other criminal activities

The BSA requires financial institutions to have a written, board-approved compliance monitoring program. The program must:

-          Provide for a system of internal controls to assure ongoing compliance;

-          Provide for independent testing for compliance;

-          Designate an individual responsible for coordinating and monitoring day-to-day compliance; and

-          Provide training for appropriate personnel.

In addition, the implementing regulation for section 326 of the PATRIOT Act requires that every bank adopt a customer identification program identification program as part of its BSA compliance program.

Reporting Requirements under the BSA

The BSA includes the following reporting requirements (these are administered by the US Department of Treasury's Financial Crimes Enforcement Network (FinCEN)):

-          FinCEN Form 104 - Currency Transaction Report (CTR)

-          FinCEN Form 105 - Report of International Transportation of Currency or Monetary Instruments (CMIR)

-          Treasury Department Form 90.22.1 - Report of Foreign Bank and Financial Accounts (FBAR)

-          Suspicious Activity Report (SAR)

-          Designation of Exempt Person Form


6 Best Practices for Complying with the BSA’s Suspicious Activity Reports Requirement

1. Implement a Proper Monitoring and Reporting System
2. Use the Appropriate Method to Identify Unusual Activity
3. Identify the Underlying Crime
4. Document the SAR Decision Making Process
5. Submit Forms that Are Thorough and Complete
6. Ensure Reports Are Filed within the Required Time Period

Expert Q&A - in computer system validation

Q - Is it mandatory to have system requirements should be high level and functional specifications be detailed ?

Ans - There is no specifically defined procedure for validation. Different process and terminologies comes under validation. Instead of using different terms like functional requirements, user requirements, functional specs, user specs, design specs, configuration specs, IT requirements, regulatory requirements, it is advised to mention everything as “system requirements”. The FDA does not care whether the requirement for the system came from the vendor, IT department or QA department. Hence rather than worrying over trying to segregate these various compartments of requirements, mention everything as “requirements “. The requirements must be written in sufficient detail such that they are complete, accurate and testable. So very high level requirements really would be the type of thing that you might have when you evaluate a vendor but requirements for validation projects should be concise and testable.

Q -What are the procedures for retrospective validation of systems that have been in production for five to 20 years?

Ans - “Retrospective validation” is an invalid term and should not be used as validation is a point in time process and systems change over time as well as the network and users and procedures. If you have a system that has been in production, rather than calling it “retrospective validation”, mention that you are going to validate your system. In the validation plan indicate that the system has been in use successfully for “X” number of years and give some good rationale for why it was not validated and indicate that you are going to validate it. 
The FDA always allows us the latitude to become more compliant. In this particular case, in your regular validation plan indicate that the system has been in use successfully but you recognize the need for validation and as such record the requirements just like you would for any system. You may have some installation records at the company already that you could use for your installation qualification. Go through the process as you would for the new system.

Q - When data are entered into a database, does that constitute a change? how to determine when change control should be documented for system changes?

When data are entered into the system, it does not constitute a change. When you set up a system or when you install your computerized system you are going to establish the baseline configuration of that system. All the software, hardware, inner phases will be documented as well as the configuration choices. Any subsequent change to that baseline configuration can only be done through change control. But data are not part of your baseline configuration and adding data to a system does not constitute change control. But any change to your documented baseline configuration which you establish at installation would be subject to change control.

If you have more questions please inbox me @  mycomplianceblog@gmail.com . i will post questions and answers of experts here

Manufacturing and Branding Cosmetics – 5 Best Practices to Follow for Regulatory Compliance

1. Determine if product is a cosmetic or drug
2. Ensure cosmetics are not adulterated
3. Brand cosmetics properly
4. Establish a comprehensive product surveillance program
5. Check ingredients are not on the prohibited and restricted list

Read in details for each best practices click here to down load this whitepaper

Handling Workplace Sexual Harassment Complaints – 5 Best Practices to follow

The laws against sexual harassment, a form of sex discrimination, are included in Title VII of the Civil Rights Act of 1964, which applies to:      employers with 15 or more employees, including state and local governments,  employment agencies,   labor organizations,    the federal government

The following types of behavior/conduct would be classified as sexual harassment:

• -       Unwelcome sexual advances,
• -       Requests for sexual favors, and
• -      Other verbal or physical conduct of a sexual nature constitute sexual harassment when this conduct:

o   Explicitly or implicitly affects an individual's employment,

o   Unreasonably interferes with an individual's work performance, or

o   Creates an intimidating, hostile, or offensive work environment

The EEOC, in its description of when and how sexual harassment can occur, says that inappropriate conduct can take place in a variety of circumstances, 

READ detail about employer's role in sexual harassment complaints, consequences of improper handling and the top 5 best practices to follow in handling sexual harassment.

Download Free White paper HandlingWorkplace Sexual Harassment Complaints

  

Importing Medical device to US - Best Practices White Paper

The FDA does not recognize regulatory approvals obtained in other countries, therefore foreign firms that manufacture medical devices imported into the United States need to comply with applicable US regulations before doing so.

• Importers should ensure that they comply with the following:
• Establishment is registered with the FDA
• Devices have been listed with the agency
• Devices are manufactured in compliance with FDA's Quality System Regulations or QSR
• Adverse events related to medical devices are reported in a compliant manner
• Premarket Notification (510(k)) or Premarket Approval have been obtained from the FDA for any device to be imported into the US
• Foreign manufacturers should have a designated agent in the US.

In addition to FDA regulations, the importers must also comply with Customs and Border Patrol (CBP) requirements.

To get a detailed account of all regulations and best practices for medical device import download this free whitepaper on medical device import.

Also you can attend the seminar -FDA's Import Requirements and Managing the Import of FDA Regulated Products: 2-day In-person Seminar

Guidelines to follow while firing - avoid counterproductively

1. It should be the last option not a option. We should be very careful and should have series of performance discussions actions, documentations and efforts to make it work
2. Be prepared for the nitty gritty of answering right to the questions which might come across in a firing meeting.  When is the official end date? Are there severance arrangements? Are there opportunities elsewhere in the company? Is career counseling available? What happens with benefits? You may need help from HR to make sure that these answers are available.
3. At the meeting be ready to listen but not react. Listen with respect and then direct the person towards the practical realities of moving on. Offer to talk again later when the emotions are not so raw, or ask a trained HR counselor to join you.
4. After the firing, talk to your team about the process, the reasoning, and the implications for them (within the limits of confidentiality).
5. Do not avoid facing your team and talking about reality as it is.

Related Training - 

Effective Discipline and Lawsuit-Proof Termination: How to Remedy Performance and Conduct Problems While Minimizing Your Legal Risks

Design Control Best Practices - Free White Paper

Inadequate design controls continue to be highlighted by the FDA as a major reason for warning letters issued to medical device companies. Manufacturers who have lax controls over design and development of devices also have to recall products as they may endanger user safety. Such actions have a negative impact not just on company profit margins, but also reputation and public trust.

This white paper discusses six best practices that medical device manufacturers should follow

1. Robust and Detailed Design and Development Plan
2. Ensure Design Input Includes All Necessary Elements
3. Carry Out Detailed Design Reviews
4. Verify and Validate Device Design
5. Do Design Transfer Correctly
6. Maintain Complete Design History Files

CLICK HERE TO READ THE DETAILS OF THIS WHITEPAPER

What is FMEA and How to Use it

Failure Modes and Effects Analysis is the subject of an international standard, IEC 60812-Analysis techniques for system reliability-Procedure for failure mode and effects analysis (FMEA)

The only international standard that applies for FMEA is IEC 60812, which shows general application, but does not show the use of the tool in risk management.An extension to the FMEA allows analysis of the criticality of a failure, such an analysis is called FMECA or Failure Mode and Effects Criticality Analysis

Most medical device companies use FMECA, although they incorrectly label it as “FMEA”

Failure Modes and Effects Analysis was developed as a tool to explore the effects of failure of components on the reliability of various products.The tool was developed as a tool for use in the field of reliability engineering to explore where more rugged components would be required to obtain desired product life

The title of the standard, Analysis techniques for system reliability-Procedure for failure modes and effects analysis (FMEA), reflects its correct use

Use of FMEA
As an input to the Risk Management process FMEA should be used to:

Solvency II

Solvency II is a new, stronger EU-wide requirement on capital adequacy and risk management for insurers with the aim of increasing protection for policyholders. The strengthened regime should reduce the possibility of consumer loss or market disruption in insurance.

Solvency I was a minimum harmonization directive introduced in the early 1970s. It allowed for differences to emerge in the way that insurance regulation was applied across Europe leading to different regimes. It was also primarily focused on the prudential standards for insurers and did not include requirements for risk management and governance within firms.

Solvency II aims to achieve consistency across Europe on the key ideas of:

• Market consistent balance sheets;
• Risk-based capital;
• Own risk and solvency assessment (ORSA);
• Senior management accountability; and
• Supervisory assessment.

The Solvency II Directive states that the new regime will go live on 1 November 2012 when it will replace the Solvency I requirements and the current regulatory regime for insurance supervision for firms in the UK. The European Commission’s (EC) proposals for the Omnibus II Directive include an amendment to the implementation date by two months to 1 January 2013.

The new regime will apply to all insurance firms with gross premium income exceeding €5m or gross technical provisions in excess of €25m. Some insurance firms will be out of scope depending on the amount of premiums they write, the value of technical provision or the type of business written.

Solvency II principles and rules apply to Lloyd’s of London syndicates in full. Due to its specific nature, some of the Solvency II requirements are being considered for their application to Lloyd’s.

European process

Solvency II is being created with a four-level process or the ‘Lamfalussy processes

Process validation process

Following processes to be validated are

– Aseptic filling processes
– Sterilization processes
– Clean room ambient conditions
– Sterile packaging sealing processes
– Lyophilization process
– Heat treating processes
– Plating processes
– Plastic injection molding processes
– Routine end-product tests have insufficient sensitivity to verify the desired safety and efficacy of the finished devices
– Clinical or destructive testing would be required to show that the manufacturing process has produced the desired result or product
– Routine end-product tests do not reveal all variations in safety and efficacy that may occur in the finished devices
– The process capability is unknown, or it is suspected that the process is barely capable of meeting the device specifications

Process Validation steps

1. Determine the need to validate
2. Determine what to validate (IQ, OQ, or PQ)
3. Write a validation protocol
4. Conduct the protocol and collect the data
5. Analyze the data
6. Improve the process, as warranted, based on the data and analysis
7. Prepare a report
8. Maintain the documentation as a quality record

Types of Process Validation

Prospective
– Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may affect the product's characteristics.

There are three phases of prospective
validation:
– Installation qualification (Process equipment consistently operates within established limits and tolerances)
– Process performance qualification (The process is effective and reproducible)
– Product performance qualification (The finished product produced by a specified process meets all release requirements for functionality and safety)

Concurrent
– A subset of prospective validation conducted with the intention of ultimately distributing product manufactured during the validation study

Retrospective
– Validation of a process for a product already in distribution based upon accumulated production, testing and control data


In this validation there is an assumption, typically unmet, of complete records
– Customer complaints not investigated
– Investigations without adequate corrective action
– Scrap and rework not fully documented
– Inadequate process variability records

Sponser Meeting with FDA some facts

There are many meetings which a sponser can have with FDA related to the product being developed and to be approved by FDA. But it can be categorized in to 3 base categories.

Type A: Critical Path (Urgent) meetings – Clinical hold, Safety Issues, Site disqualification, etc (within 30 days)
Type B: Procedural meetings – Pre-IND meeting, EOP2, pre-NDA, etc (within 60 days)
Type C: Miscellaneous meetings – CMC issues, mid-P3, early-review, mid-review, etc ( within 75 days)
Formal meetings are not the only way you communicate with the FDA: comment requests, emails, telecons with the RPMs, etc.

Why meeting FDA?

- Sponsors have the right to request a meeting with the FDA review division
- These meetings are specifically to help prescription drug approvals
–Not granted if FDA perceives that an IND is not being planned
–More for issue resolution while product development than scientific rationale
–Clarification and discussion, not “interrogation”
- Pre-submission meetings (pre-IND, EOP2, pre-NDA) meetings are considered critical by FDA compared to mid-cycle meetings (mid-P3, mid-review, etc)

Time for meeting
1. Developed “final product” idea
–Finished formulation
–Target indication(s) and population(s)
2. CMC information
–Characterization
–Manufacturing and packaging (cGMP)
–Stability studies
3. Basic non-clinical studies (GLP)
–Acute and sub-acute toxicology
–Pharmacology
–In vitro toxicity tests
4. Ready to initiate clinical studies
5. Have sufficient GMP level investigational product
6. The pre-clinical studies demonstrate MTD, NOAEL, major expected adverse events
7. Scientific rationale for mechanism of action is available
8. Clinical development plan is proposed

FCPA Act Anti-bribary provisions

1977 Congress passes FCPA act to stop bribery and restore public confidence in U.S. business systems.
it has 2 sections Anti -Bribery and accounting provision.
Anti-Bribery provison is enforced by DOJ (department of justice) and it helps in Prohibiting corrupt payments (bribes) to foreign government officials, political parties, party officials and candidates in order to obtain or retain business
It has five elements of violation

Recent News - 

SEC Asks Tesco to Retain FCPA Compliance Documents

1- Who comes in its purview :–public companies filing periodic reports with SEC
–Any U.S. citizen, national or resident
- Any corporation, partnership, association, unincorporated organization & sole proprietorship with principal place of business in U.S. or organized in a U.S. state
- If a bribe occured within U.S. then it must use of U.S. mails, interstate telephone, facsimile, wire transfer or interstate or international
- If a bribe occured outside the U.S. then it is not subjected to such requirements
–Foreign companies & nationals if they cause, directly or indirectly through agents, an act in furtherance of a bribe to take place within the U.S.
–U.S. parent corporations if they authorize, direct or control questionable activity of foreign-incorporated subsidiaries
–U.S. citizen & residents employed by or acting on behalf of foreign-incorporated subsidiaries

2- Intent - Payment must be intended to cause foreign official to use his/her influence or misuse his/her position to improperly direct business to payer or some other person.
3-Payment - FCPA violation occurs if there is: A payment or authorization of a payment, An offer to pay or , A promise to pay but there is no minimum value.
4 - Recepients
FCPA applies to:
•Foreign official - Includes officer or employee of a foreign government or public international organization, regardless of rank or position
•Member of a royal family
•Official of state-owned business enterprise?
•Foreign political party or party official
•Candidate for foreign office
5 - Business Purpose
Purpose of payment must be to assist in obtaining or retaining business. However, business need not be with the foreign government, e.g. bribe is made to foreign government official to pressure a private in-country business to award a contract to a U.S. company.

Supplier Qualification Regulations

There are various regulations formulated by different agencies highlight as a whole or part the supplier qualification guidelines. few are below.
ISO 13485 -
–Clause 4.6.2: Assessment of Sub-contractors–ISO 13485:2003 – Clause 7.4.1 mimics previous clause; standard adds explicit reference to “outsourced process” (4.1)

Requirements -
–Clause 7.4.1 - The type and extent of control applied to the supplier… shall be dependent upon the effect of the purchased product on… product realization or the final product.”
–The organization shall evaluate and select suppliers based on their ability to supply product in accordance with…requirements.
–Criteria for selection, evaluation, and re-evaluation shall be established.
–Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.

FDA–GMPs : No requirement, but sometimes “unofficially” reviewed during inspection
- 21 CFR 820.50 – Purchasing Controls: “all …product and services…”
- 21 CFR 820.50(a) - Evaluation of suppliers, contractors, and consultants

Allergen Labelling

The various methods of allegen labelling are as follows
- All retail products must have Allergens labelled.
- Restaurant employees must be able to control and discuss allergen presence with customers.
- Common names must be used
- The allergen may appear in bold following the ingredient containing the allergen, on the label
- The allergen and Contains statement must be of equal size and style type.

Sometimes it contains "May Contain" statements to address potential cross contamination. This type of practices should be avoided as .
- It is confusing for consumers and limits product appeal.
- It shows an inadequate allergen control program.

You should include similar allergen control program requirements in the supplier approval program for incoming ingredients as.
- Allergen labeling of incoming ingredients is a necessity for accurate product labeling.
- Allergen testing or Certificates of Analysis for newly approved ingredients is a good way to measure labeling accuracy.

http://www.fda.gov/food/labelingnutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106187.htm

Top 5 GCP violations

- Protocol non-adherence: Failure to follow the protocol or notify the IRB of problems
- Clinical Records not well documented: They are incomplete, inaccurate or out-of-date. 483 bait
- Informed Consent problems: Incomplete, language issues, back dated, process absent or in question
- Investigational product supply chain accountability: Failure to account for each and every product/pill.
- Adverse Event collection and reporting: from severity determination to reporting errors occur

A clinical trial inspection - general procedure

• Review of the procedures, frequency, scope and process of the sponsor / CRO used to monitor progress
• Reviewing SOPs and Monitoring Plans, interview personnel, and read trip reports
• Review of items to determine that the clinical study / investigation was conducted in accordance with the signed protocol that was submitted to the FDA
• An assessment of protocol deviations or violations from the approved protocol or FDA regulations and how the sponsor / CRO handled them
• An Assessment of training records, SAE reporting, drug accountability,
• Particular attention to both non-compliant sites and the highest enrollers
• Inconsistencies such as protocol deviations, source documents not mirroring CRFs, unclear informed consents, confused Pis
• Is the PI in compliance with the FDA Form 1572
• Making sure the IC process was clear sans coercion
• Do all subjects meet all Inclusion / exclusion criteriaIs the data reasonable and fits the sourse data
• Are all IRB/IEC approvals reasonable / appropriate

to Know more attend the training

GCP violations and Site Mistakes commonly found During a FDA Investigator Site Inspection/Audit

Records FDA inspectors look for - related to Quality system

The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. QSR allocated the information into four documents.

1. The Design History File (DHF) gives a history of device design. One of the design outputs is the Device Master Record (DMR).
2. The Device Master Record (DMR) contains all the information necessary manufacture, install, service, and maintain the device.
3. The Device History Record (DHR) has the objective evidence to support the device production history.
4. The Quality System Record (QSR) contains information that is not device specific.

A compliant Quality Management System (QMS) should be able to address these questions quickly and easily.

• The list of the records that belong in the Design History File (DHF)?
• Can your team relate the component specifications in the DMR to the Purchasing Data you use to obtain the components?
• What are the records you must keep when you verify the component at receiving?
• Which of these records must go into the DHR?
• What is the list the activities that require a designated individual?
• Do you have quality records that designate the individual and demonstrate training to perform the assigned responsibility?
• How to assure that the designated individual, not somebody else, performed the activity before you released the product for distribution?
• Some information could be in the DMR or the QSR. Does you team know how to make the decision?