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What is a Free Trade Zone? A free trade zone (FTZ)is a designated area that eliminates traditional trade barriers, such as tariffs, some kind of taxes and fees and minimizes bureaucratic regulations. The goal of a free trade zone is to enhance global market presence of the Country or location by attracting new business and foreign investments. Tax-free trade zones generate foreign exchange through exports, and create economic value added. Free, foreign, and export processing zones all fall under the umbrella of being free trade zones. Because these terms are confusingly similar, they are often used interchangeably.

Free trade zones

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What is SEC? The U.S. Securities and Exchange Commission (SEC) oversees the key participants in the securities world. Concerned with promoting disclosure of important market information, maintaining fair dealing, and protecting against fraud. Responsibilities include: Interpret and enforce federal securities laws Issue new rules and amend existing rules Oversee inspection of securities firms, brokers, investment advisers and ratings agencies Oversee private regulatory organizations in securities, accounting, auditing fields Coordinate U.S. securities regulation with federal, state, and foreign authorities SEC Organization: Division of Corporate Finance:Reviews documents required to be filed with the Commission Division of Trading: Assists in maintaining fair, orderly and efficient markets. Division of Investment Management: Maintains oversight of America’s $26T investment management industry Division of Enforcement: Recommends commencement of investigations of SEC law violations Division of Economic and Risk Analysis: Integrates robust economic analysis and data analytics Laws Governing SEC: Securities Act of 1933 Securities Exchange Act of 1934 Trust Indenture Act of 1939 Investment Company Act of 1940 Investment Advisers Act of 1940 Sarbanes-Oxley Act of 2002 Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 Jumpstart Our Business Startups Act of 2012 SEC Reports: 8k - A report of unscheduled material events or corporate changes at a company that could be of importance to the shareholders or SEC 10k - Comprehensive summary report of a company's performance. Submitted annually to the SEC 10Q - A comprehensive report of a company's performance that must be submitted quarterly by all public companies to SEC. In10-Q, firms are required to disclose relevant information regarding their financial position. 18K - Use to update the SEC and investors regarding the status of a domestically traded foreign security and its issuer. 20F - A form issued by the SEC that must be submitted by all "foreign private issuers" that have listed equity shares on exchanges in the U.S. SEC Investigations: Can be triggered in many ways Investigation is not the same as prosecution Investigations involve fact finding and are usually not public During an investigation, neither the staff nor the Commission makes any determination of wrongdoing Following investigation, SEC staff present findings to the Commission Commission can authorize the staff to file a case in federal court or bring an administrative action.

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What Constitutes a GRC Program? Governance, risk and compliance or GRC programs are complex – an organization has to use its GRC program to address the regulatory requirements expected of, among others, the following: Enterprise Risk Management COSO Internal Controls Environmental Compliance (EPA rules) Anti Trust Anti Money Laundering Anti Bribery/Corruption Quality Management and Standards such as ISO 9000, 9001 Process Management such as Six Sigma Anti Harassment Human Capital Whistle-blowing HR Processes The areas listed above are just few of those that come under the purview of a robust GRC program. Why Audit a GRC Program? Given the complex nature of regulations around the world today and the increasing risks of doing business, it is important that the GRC program in an organization is audited frequently. Most of the lapses in corporate governance occur due to outdated GRC programs that have not been audited and updated to reflect the current regulatory environment. Internal audits of GRC programs allow management and the board to identify risks and areas that need strengthening and root out any non-compliance. An audit can help evaluate the adequacy of the program’s design and effectiveness as well as new practices and technologies to be implemented. Audits of the GRC program have to be carried out periodically – these should supplement an ongoing, daily evaluation of the effectiveness of the program, including monitoring of controls and responses. Internal Audit Process – The General Steps: Define evaluation scope, objectives, and the type of evaluation. Define the level and type of assurance Identify the evaluation team and skills required. Develop evaluation plan. Perform design adequacy evaluation. Perform operational effectiveness evaluation. Communicate evaluation results and ensure follow-up to address issues.

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What is Workplace Harassment? Harassment is any unwelcome verbal or physical conduct based on protected bases (race, color, religion, sex, national origin, age, disability, retaliation, and sexual orientation) when: The conduct culminates in a tangible employment action, or The conduct was sufficiently severe or pervasive to create a hostile work environment. How to Determine Harassment Exists? To determine whether the harassment exists: Evaluate frequency and severity of misconduct Apply reasonable person standard Would a reasonable person find the behavior hostile, intimidating or abusive? Tangible effect on job not necessary Psychological harm not necessary What is Sexual Harassment? EEOC defines sexual harassment as: Unwelcome sexual advances Requests for sexual favors Other verbal or physical conduct of a sexual nature Two most common forms of sexual harassment are: Quid pro quo harassment Hostile work environment harassment Who Can Be Involved in Harassment? Those who commit, employees at all levels: Manager Co-worker Customers Vendors Members of opposite sex, members of same sex, etc. Those who are targeted: Victims Bystanders Witnesses who are affected by the harassment 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

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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

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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

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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

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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

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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

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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 RoutineLaboratories 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

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