Webinar: Updated COVID-19 HIPAA Compliance When: Tuesday May 4, 2021 - 01:00 PM Duration: 60 Minutes. This webinar will be up to date on the day it is presented because we continuously track the modifications announced on almost a daily basis to Health Information Privacy Regulations to deal with the COVID-19 Public Health Emergency. continue to be announced on almost a daily basis by OCR, HHS and CMS. New Federal guidance from OCR, CMS, HHS and the CDC announces temporary emergency changes while explaining how existing HIPAA Rules for public health emergencies are to be followed. important Federal guidance. All Covered Entities and Business Associates need to know how to comply with modified HIPAA compliance procedures that are temporarily in place during the pandemic and refresh their familiarity with HIPAA Rules designed for all public health crises. Areas Covered in the Session: HIPAA Privacy Rule and Security Rule Brief review of basic HIPAA Privacy and Security Rule requirements for Uses and Disclosures of Protected health Information (PHI) that remain in effect and apply in a public health emergency like the COVID-19 infectious disease outbreak to protect providers, first responders and patients COVID-19 Telehealth Modification Resources Up to date links to current resources and PDF Handouts OCR Suspension of Telehealth-related HIPAA Enforcement Medicare Telehealth Service Modifications Substance Abuse Treatment - COVID-19 & Beyond Best Practices for Special COVID-19 Modifications Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance When: Tuesday May 4, 2021 - 01:00 PM EDT Duration: 75 Minutes. Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time. Areas Covered in the Webinar: Avoid 483s and Warning Letters. Ensure compliance with 21 CFR Part 11 when using Excel spreadsheets for GxP data. How to use cell and file protections. How to use Excel’s audit trail. Reduce validation time and costs. Increase compliance while lowering resource needs. Understand what validation documentation is required. Hands-on workshop to address your specific needs. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: HIPAA HITECH Changes 2021 - What's New? When: Thursday Apr 29, 2021 - 01:00 PM EST Duration: 90 Minutes. This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA HITECH is now fully enforced with bipartisan support and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump (or Biden) administration, new congressional mandates and any other applicable updates for 2021 and beyond along with changes relating to COVID19 and Information Blocking under the Cures Act (do’s and don’ts). There are an enormous amount of issues and risks for covered entities and business associates these days - we will speak to the most common violations and fines - and how to best avoid fines and headaches. Areas Covered in the Session: Updates for 2021 and beyond COVID19 and HIPAA Changes Cures Act - Information Blocking (do's and don'ts) Fines Portable devices Texting and Emailing - new guidelines Politics and HIPAA Changes under OCR Director and congress New Definition of protected health information Real life audits and litigated cases Business associates and the increased burden Breach notification Paperwork that needs to be updated Risk factors Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Sampling by Variables When: Wednesday May 26, 2021 - 03:00 PM Duration: 60 Minutes. ANSI/ASQ Z1.9 (formerly MIL-STD 414) is an acceptance sampling standard for product characteristics that are measured in terms of real numbers. While the textbook approach is very straightforward, users need to be aware of considerations such as (1) the assumption that the data follow the normal or bell curve distribution and (2) switching rules for normal, tightened, and reduced inspection. This presentation will cover the basics of ANSI/ASQ Z1.9 along with these other considerations. The handout for the presentation will meanwhile include a technical appendix that shows where the operating characteristic (OC) curves in the standard comes from. Areas Covered in the Session: 1. Introduction to ANSI/ASQ Z1.9, formerly MIL-STD 414. (The examples in the webinar will use the public domain tables from MIL-STD 414 as opposed to the copyrighted ones in ANSI/ASQ Z1.9; the procedures are however identical.) It is vital to realize that the entire standard relies on the assumption that the quality characteristic follows the normal or bell curve distribution. · Other considerations include the need for random sampling, i.e. each item has an equal chance of being measured, and the need for the items to come from (as an example) a lot that has been subjected to homogenous processing conditions. 2. The sampling plan depends on (1) the lot size, (2) the level of inspection, and (3) the acceptable quality level (AQL) at which it is desirable to accept most (roughly 95%) of the lots. · Switching rules meanwhile dictate normal, tightened, or reduced inspection. · Plans depend on whether the standard deviation is known or must be inferred from the sample statistics. · Plans also depend on whether we are dealing with a 2-sided or 1-sided specification, and whether the (1) known standard deviation, (2) sample standard deviation, or (3) sample range is used to infer the variation. In addition, when there are two specification limits with separate AQLs, it is possible to use ANSI/ASQ Z1.9 regardless. · When the sample range is used, it is vital to note that average ranges (e.g. the average of two ranges for groups of 5 from a specified sample size of 10) are used as opposed to the range of the entire specified sample (e.g. the range of the 10 measurements). If the sample size is 15, then the average of 3 ranges for groups of 5 would be used similarly. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Online Seminar: 2-Day Virtual Seminar Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries) When: Thursday & Friday 10 -June &11-June 2021 Day 1 & Day 2 (11:00 AM - 5:00 PM EST) Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering later stages of Phase 2 or Phase 3 clinical trials and plan to have a product ready for market approval in the coming months. Most such companies are small, and may not have deep expertise in QA and GMP compliance, relying on their partners to cover those areas. Companies that outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOS), Contract Research Organizations (CROs), and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace. You will also learn best practices for managing a regulatory inspection, with emphasis on FDA, EMA and Health Canada, but applicable to most other major agencies as well. Learning Objectives: Participants in this seminar will: Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations Understand how to select, qualify and monitor CMOs, CROs, and Contract Laboratories Learn the elements to include in a quality agreement (also known as a technical agreement) Learn how to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource Understand your obligations under the law for products you release to the clinic or the marketplace. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Preparing for OSHA Requirements for COVID-19 prevention When: Thursday May 13, 2021 - 01:00 PM Duration: 60 Minutes. The 2019-2021 Covid-19 epidemic has cost hundreds of thousands of lives and has also caused enormous disruption to businesses and supply chains. Many small businesses such as restaurants have closed for good, and larger businesses have suffered enormous losses. The good news is however that off-the-shelf Nonpharmaceutical interventions (NPIs) as recommended by OSHA, ASHRAE, and other authoritative sources can reduce the risks to workers and customers, and also to continuity of operations. Some of the adaptations to the epidemic, such as working from home along with distance education and distance conferencing have proved meanwhile to be very cost effective, and a strong argument can be made for continuing to use them even after the new vaccines eradicate this disease. 1. The HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act) would have required OSHA to develop a standard for protection against occupational exposure to pathogens such as COVID-19. · Even though this was not enacted into law in 2020, there is a chance that subsequent legislation may require this. · Even if no law or regulation requires compliance to a standard of this nature, we have an ethical obligation to protect workers, customers, and other stakeholders from Covid-19 and anything like it. There is also an overwhelming business case for ensuring continuity of operations, noting that businesses have in fact been shut down due to outbreaks while supply chains also have been affected. 2. OSHA’s "Guidance on Preparing Workplaces for COVID-19" gives us a good idea of what to expect in a standard and can be used immediately regardless of whether a standard is developed. 3. Planning requires consideration of two principal contagion sources; coughs and contaminated surfaces. 4. Reduce the risk through, for example, curbside pickup and home delivery. 5. Personal protective equipment (PPE) is a last line of defence. 6. Eliminate the risk through telecommuting, distance conferencing, and distance education. This has proven very cost-effective and should, in most cases, be continued even after the disease is eradicated. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Next Generation Risk Management: Effects of COVID-19 on ERM When: Thursday May 20, 2021 - 01:00 PM EST Duration: 60 Minutes. This is the first webinar, and the only one to date, that introduces new concepts that enhance risk management. Risk profiling, different than risk assessment, is a necessary tool for businesses today. It is more complete, more holistic and more efficient. Arguably, the ability of a business to respond to events has proven much more valuable than the ability to predict, or one could say, not predict, risk events. Should ERM focus on response more than prediction? We should at least ask the question. How do AI and Data Robots play a part in the new generation of risk management? And finally, Governance, which plays a big role in response, should be strong so how do we know our governance programs are effective? Explore these topics from a somewhat radical but progressive perspective. Areas Covered in the Session: · Understand the meaning of G.R.I.P · Learn details of a strong Governance Program · Discover the value of data robots and AI in risk management processes · Build on how to excel and responding to risk events · Confirm the role of risk assessment and see why profiling is better · Examine the value of Risk Profiling for businesses Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Medicare Annual Wellness Visits - 2021 Updates When: Wednesday Apr 28, 2021 - 11:00 AM EDT Duration: 60 Minutes. The "Welcome to Medicare" visit and Annual Wellness Visits (AWV) are important screening services available to Medicare beneficiaries at no cost. More and more practitioners are providing these services, often missing key elements to support the codes. In this session, we will look at these services and discuss the typical problems providers are struggling to document when performing these visits. Areas Covered in the Webinar: Required components for the IPPE Required components for the AWV Who is eligible? Who can provide these services? Where can they be performed? Documentation required to bill these services When to bill or not bill an E/M code with these services Other covered preventive services Find answers to your questions about IPPE and AWV services. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Employment Records and How to Keep Them When: Tuesday Apr 27, 2021 - 01:00 PM EST Duration: 120 Minutes. Employment records are extensive and complex, the FFCRA has added new records to keep – without clear guidance. Human Resources, payroll, safety, and auditing professionals have ongoing questions about what employment records are required to be retained, and for how long. However, this is only the start of the issues. The legal requirements and employer liabilities go far beyond these simple issues. Your record keeping procedures are an important consideration when it comes to a dispute with a current or former employee, and whether your documentation will even hold up before a Court, the EEOC, or some other regulatory agency. Areas Covered in the Webinar: What is a “record” – you may be surprised. The new FFCRA records, and where they fit within the laws. Caution about FFCRA records. How do you keep records? Who has access? Why are you in trouble if you only follow the legal time requirements? Should you “archive” all records? What creates “records?” What creates “problem records” you did not even know you had? What records should you NOT create? The penalties for NOT preserving that the laws don’t even mention. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Introduction to ACH: The Basics When: Tuesday Apr 27, 2021 - 01:00 PM EST Duration: 90 Minutes. The ACH product has been around for a long time and it’s easy to get complacent with it. It always works, so why mess with it. But, do you really understand what it is and how it works? This session is designed for those that are new to operations and those that want to confirm they really understand ACH. Areas Covered in the Webinar: Knowledge of how the ACH payment system works An understanding of commonly used ACH acronyms and terminology Examples of the primary participants in the ACH system An overview of the responsibilities of the participants An awareness of the different types of ACH entries. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Seven Habits of Effective Credit Administration in Commercial Banks When: Tuesday Apr 27, 2021 - 01:00 PM EST Duration: 120 Minutes. Imagine finding yourself suddenly in a senior credit administration position at your bank due to required personnel changes as a result of frequent credit losses; Or, your bank's credit administration seems disconnected, un-organized and free flowing and lacks effective management oversight; Or you are in a lending position and the credit administration function at your bank fails to provide structure, guidance and leadership. If any of these scenarios point to you or your financial institution, this course will address the factors you need to know to make a positive difference in the credit administration at your bank. The Seven Characteristics are as Follows 1. Well Defined Credit Culture Established and Supported by: An Effective Loan Policy 2. Highly Effective Risk Assessment and Credit Underwriting System by: Choosing the right personnel to be Credit Analysts, Lenders or Loan Administrators Knowing how to balance Risk and Rewards through proper credit, ratio and cash flow analysis Knowing how to report risk assessment by writing effective credit memoranda 3. Highly Effective Credit Committee that: Considers all pertinent information Allows members to express their opinion "freely" Records Minutes that matter. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar:2-Day Virtual Seminar Clean room, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers When: Monday & Tuesday May 10-11 May DAY 01 & DAY 2 (9:00 AM TO 4:00 PM EDT. This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection. The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures),Gowning Controls, Personnel Training, Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy), Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program and the Basics of Sterilization Processes- Physical and Chemical Processes will also be discussed. The various regulatory bodies’ requirements such as 21 CFR Part 211 (mostly relevant 211.113 “Control of microbiological contamination”, ISO 14644 (Various Parts), FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice”) amongst others and the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products are important to the quality determination and release of the finished manufactured products. The seminar will consist of two (2) Parts for a total of 6 Modules. There are seven (7) key topics that will be discussed on Day 1 and Day 2 of the Seminar are as follows: Cleanroom Regulations, Classifications, Basic Background and Design Considerations Cleanroom Qualification, Cleaning Validation (IOQ/PQ), Routine Monitoring and Excursion Investigation Environmental Monitoring Program (Monitoring, Excursion Investigation and Trending of Data) Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures) Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy) Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program Basics of Sterilization Processes- Physical and Chemical Processes Bonus:Compliance Expectations, FDA Form 483’s and Case Studies. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Standby Letters Of Credit (for Credit Managers) When: Friday May 28, 2021 - 03:00 PM EDT Duration: 90 Minutes. This session will take an in-depth look at how standby letters of credit work and the reasons they sometimes don’t. Participants will learn how to protect themselves against non-payment. Course Objective Many people think of standby letters of credit as nearly equivalent to cash. What they don’t realize is that many letters of credit don’t get paid when called upon. Most often this is due to misunderstanding how standbys work and then failing to present the documents correctly; indeed, occasionally it is not even possible to present the documents that are called for. Sometimes it is because the bank that issued the standby is ordered not to pay by a court either because the customer has gone bankrupt and payment is deemed a preference (exactly what you thought the standby was protecting you against) or because the customer claims you have no right to the payment and has managed to get an injunction. And sometimes it is because the bank that issued the standby has been declared insolvent and the regulators (e.g., the FDIC) have repudiated the standby. Course Outline Mechanics and Principles of Letters of Credit Confirmed Letters of Credit What Is a Standby Letter of Credit? Uses for Standby L/Cs Competing Rules Governing Standby L/Cs: Which to Use Things That Go Wrong and How to Avoid Them Tips for Using Standby L/Cs Better Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Flexible Work Arrangements: The Future of Employment in 2021 When: Thursday May 20, 2021 - 11:00 AM EDT Duration: 90 Minutes. This webinar will discuss the benefits of workplace flexibility, address myths about flexible work arrangements, and arm participants with the tools they need to establish and effectively manage workplace flexibility. Areas Covered in the Webinar: Defining flex work arrangements Understanding the various types of flex work arrangements Potential legal pitfalls to avoid Benefits of a flex work schedule for employers & employees Advantages and disadvantages of flex work programs Instituting a flexible work environment Developing a flex work policy Implementation challenges Measuring the effectiveness of flex work arrangements Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Masters Classes on US Pharmaceutical Regulatory Affairs Professional Certification Program When: Thursday May 13, 2021 - 11:00 AM Duration: 8 Hours. Description of the Topic: Program describes the essential requirements for obtaining approval of a new drug in the USA, the 'NDA Process'. The program describes preparing submissions using the Common Technical Document (CTD) Form and requirements for obtaining approval of human medicinal products in the US. Courses that are included in this program are: Essentials for Human Medicinal Products; Orphan Drug Application; How to Gain Approval to Market Generic Drugs in the US; Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US; Preparing Submissions in the Common Technical Document (CTD) Format; Electronic Common Technical Document (eCTD); The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA; and Registration of Drugs Based on Monoclonal Antibodies. Areas will be covered during the Session: This course gives a definition of regulatory affairs and outlines the function and evolution of regulation in the pharmaceutical industry as well as providing a source of key legislation and guidelines. National and international regulatory authorities are introduced including the legal frameworks in the USA and EU. It describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area. The procedures for making an application are detailed, that includes the acquisition of protocol assistance and collection of supporting data. In Europe, the Centralized Procedure is now the mandatory method to gain authorization for marketing of orphan products. Learn what is needed for the regulatory approval of the Common Technical Document, the use of the Common Technical Document and its structure, and the conversion of other formats to Common Technical Document. This course discussed the eCTD hierarchy, life cycle management and structure of the five modules and explores the workflow around planning, creating and submitting an eCTD - particularly setting up the modules, and migrating and validating the data. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Form 1099 & W-9 Update - Complying with IRS Information Reporting Guidelines When: Tuesday May 11, 2021 - 01:00 PM EST Duration: 60 Minutes. This IRS regulatory compliance training will focus on the rules requiring W-9 documentation and 1099 reporting. Attendees will learn the best practices to ensure compliance with IRS and avoid B-Notices. Areas Covered in the Webinar: How can we best set up an independent contractor or bank customer in our payment system to ensure compliance with the IRS reporting rules? Protocols for setting up new payees and vendors (ICs) When to require a Form W-9 v. Form W-4 v. Forms W-8 Review the current Form W-9 (released October 2018, or newer if applicable) How to test the accuracy of the W-9 information with the IRS’s records – for free! Who and what you pay determines whether you must report (1099 reporting) When and how to handle back-up withholding When signatures are required on Form W-9 Update on the latest changes to the forms, deadlines and penalties When you must electronically file your information returns How to set up electronic reporting to your payees Form 1099-Misc – detailed guidelines for proper use and classification of diverse payments on this form How Merchant Card reporting on Form 1099-K affects your reporting on credit card payments How FATCA affects information reporting for U.S. persons Best practices for filing 1099s with the IRS – TIP: never file early! The government wants to remove the exemptions – what this means to you. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar

Webinar: Conducting Your "NEW 2021" Annual ACH Rules Compliance Audit - a Step-by-Step Guide When: May 5, 2021 - 12:00 PM Duration: 90 Minutes. This training program will outline the recent changes to the process of the annual ACH Rules Compliance Audit and the removal of Appendix 8 from the Rules Book. It will outline what this Rules change means to your process when conducting your ACH Audit and offer tips and guidance for creating your own personalized ACH Audit. It will also help attendees to identify the details of the ACH audit for each participant, the ODFI, RDFI, TPSP and TPS with NACHA’s Operating Guidelines. Areas Covered in the Webinar: Outline the changes to the process of the annual ACH Rules Compliance Audit and the removal of Appendix 8 from the Rules Book Define what the General Audit Requirements are (now in Article 1) Discussion on the NACHA Operating Guidelines where the new “guidance” is located for conducting the annual ACH Rules Compliance Audit. Discussion on flexibility when conducting the Audit for each participant, the ODFI, RDFI, TPSP and TPS with NACHA’s Operating Guidelines Describe “how-to” ensure Rules Compliance after determination of what ACH activities are being audited Recommended areas to check (audit) in addition during the ACH Audit. Contact Person: SAM +1 3156320735 email@plianced.com Visit Website for Register Webinar