How to Read and Understand an Annual Report

Accounting and finance is supposed to be the international language of business. If so, then why do we struggle so much to make sense of the numbers? Are we so busy managing our business and leading our staff, that we don’t have time to wade through the financials, discover the trends, draw proper conclusions and take appropriate action?

Analytical Instrument Qualification and System Validation

Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance.

Offboarding with Care: Conducting Legal and Ethical Employee Terminations

If an employer has exhausted all the necessary steps to help the employee improve his or her work performance – and those steps are not working – it may be time to terminate the employee. Terminating an employee is not only stressful for the employee losing a job, but also for the employer. There are legal, ethical steps to take when you terminate an employee.

FinCEN’s CDD Rule and the impact of the AML Act of 2020

The FinCEN has issued substantial new AML requirements focused on a major expansion of Know Your Customer into what is now Customer Due Diligence, CDD. This webinar will present various aspects of the requirements.

Major CGMP Issues - US FDA Concerns in 2022

This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.

Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible

This instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business. 
The use of quality risk management in pharmaceutical operations does not preclude the requirement for a company’s compliance to all applicable regulations.

USMCA Rules, Procedures and Documentation

This webinar will help attendees understand how to meet the rules that are required to qualify their imports/exports between the three USMCA countries (United States, Canada, and Mexico). In addition, this webinar will present some of the major changes between the NAFTA & the USMCA and how these changes may affect the qualification of your products.

Introduction to the Ishikawa Fishbone Diagram

The global marketplace is faced with a dilemma as to how they categorize their human capital assets. This has been brought about by the changing nature of employment in general. The results are new paradigms in working with our most valuable corporate asset. This webinar looks at the changes and what the future holds for your organization.

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.

Updates to the NACHA Operating Rule Changes 2022 and Beyond!

The NACHA Operating Rules are always changing, updates have recently been made and continue to be in place due to the current COVID-19 situation! Four ACH Operations Bulletins posted by Nacha in 2020 explain the updates to the Rules due to changes at financial institutions and extensions of effective dates in light of the current situation;

Do’s and Don’ts of Documenting Employee Performance and Behavior

Documentation is the “fulcrum” of good employee relations. Lack of solid documentation is the single most common mistake employers make when handling discipline or terminations. Lack of or improper documentation impacts a myriad of HR issues; unemployment compensation disputes, workers’ compensation cases, and legal matters.

Being Prepared for an Active Shooter Incident at Workplace

This training program will take attendees through the actions to take when confronted with an active shooter and in assisting responding law enforcement officials. It will help recognize potential workplace violence indicators and describe actions to take to prevent and explore the General Duty Clause of the OSH Act.

Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products

Sterile products may be broadly classified into two main categories based on their production mode -- those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled, and then sealed.

REACH and RoHS Compliance: Gain a Deeper Understanding

This 2 day virtual seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your organization can benefit from the mistakes of others. We will review the latest on both directives and will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.

Current Events

Personal and Business Tax Returns Analysis - 1040 Federal Tax Returns, K-1 Forms and Tax Code Updates

This personal and business tax returns analysis training program will focus on key areas such as 1040 federal tax returns, K-1 forms, and tax code updates and how they affect bank’s clients. It will also discuss the structure of a C corporation, S corporation, and Partnership (including LLC) tax return.

21 CFR Part 11 Compliance for SaaS/Cloud Applications

This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.

    It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation.

HIPAA Audit and Enforcement Update for 2022 - HHS Keeps Pressure on Access, Privacy, and Security Compliance

This webinar will discuss HIPAA audit and enforcement regulations and processes for 2022 and how they apply to covered entities and business associates. Attendees will learn how to prepare for HIPAA audit to avoid fines and penalties for HIPAA violations.

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
Why Should You Attend:

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications.

Managing an Effective AML Compliance Program

Whether you need to get back-to-basics or you are a seasoned AML professional, join us as we explore the many facets of managing an effective AML compliance program:

    Regulatory frameworks surrounding anti-money laundering
    Objectives of an effective AML compliance program
    Risk assessing your institution
    Developing robust internal controls

Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government.

Supplier and Contract Manufacturer Management for Medical Device Manufacturers

This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls and Supplier Management enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls!

Incoterms® 2020 Rules

Attend this webinar to learn how to make correct use of Incoterms® to prevent delays and save additional costs. Learn how certain rules determine who is responsible for transportation, insurance, reporting the transaction to customs and much more.

Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

EPCRA TRI Form "R" Reporting

This training program will help attendees understand the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxic Release Inventory (TRI) Form R reporting requirements. It will also elucidate what the EPCRA TRI Form R is, when they are required to be filled out, and how to properly fill them out.

Conducting Your 2022 Annual ACH Rules Compliance Audit - a Step-by-Step Guide

This session will cover “step-by-step” the audit process and requirements for each participant conducting an annual ACH audit, to help ensure their compliance with the Nacha Operating Rules.

Form 941 Essentials: Keys to Payroll Tax Compliance

During the COVID-19 pandemic, Congress provided new employment tax credits and other tax relief, and Form 941 and related employment tax returns went through several major revisions to accommodate the changes. Going into the first quarter of 2022, the forms used by employers to report employment taxes continue to evolve to reflect the changes in the reporting requirements.

How FDA trains its investigators to review CAPA and what should you do to prepare

This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection.

Navigating the Interplay of the Family and Medical Leave Act, the California Family Rights Act and the Pregnancy Discrimination Leave Act

This webinar will help to clarify the legal obligations under the different laws but, more importantly, help to explain how they interact with each other, or in some cases, don’t interact at all.

HR 101: A Primer for Front Line Managers and New Supervisors

In an increasingly complicated world of employee compliance in which HR struggles just to keep abreast of new developments, not teaching managers the HR basics can be costly. After all, it’s the managers who interact with employees on a day-to-day basis, and every day is an opportunity for problems to arise that a manager was never trained how to address.

REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

This 2 day Virtual Seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your organization can benefit from the mistakes of others. We will review the latest on both directives and will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.

You should attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

SOP Writing, Training and Compliance in the Pharmaceutical Industry

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance.

Enterprise Risk Management (ERM)

Typically this involves identifying specific events or circumstances relating to the business organization's objectives (in terms of risks and opportunities), assessing them on the basis of their likelihood of occurrence & their magnitude of impact on the firm, determining a response strategy, and monitoring progress of the event, the response and the outcome.

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Each facility, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successful manufacture of each of its products.

Bank Best Practices to Prevent Fraud

Continued massive data exposures have put the spotlight on fraud risks to banks, merchants, and personal banking customers. Fraudsters are always looking for new opportunities and new weaknesses. The availability of customer data on the black-market gives them new power tools to use to enrich themselves.

Project Management for FDA-Regulated Companies

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Fraud Incident Response Planning Essentials

This 1-hour webinar is intended to sharpen the skills of auditors in assisting in the uncovering and reporting of fraud, waste, abuse and other irregularities.

FFIEC BSA/AML Examination Manual: What Compliance Officers Really Need to Know?

This webinar will go through every section of the revised FFIEC Bank Secrecy Act/Anti-Money Laundering Examination Manual to highlight changes and areas where banks should review their internal policies, processes and procedures for compliance. Understanding these changes will keep you prepared and updated for your next BSA/AML examination.

Introduction to Sales and Use Tax Compliance

Sales tax? Use tax? What’s the difference? Must I charge tax on my internet sales? Will I owe taxes in more than one state for the same sale? Why is my drop shipper charging me tax? Why did I receive a NEXUS Questionnaire and what if I don’t respond to it? I just received a notice that I have to conduct a self-audit and report my findings to the state – is this for real? I need help!

ANDA Submission and GDUFA Guidance

An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.

Case Management Boot Camp: Strategies for Success in the Acute Care Setting and Beyond!

Please join us for this intense one-day program that will give you the skills to succeed as a case manager or social worker in the new era of value-based reimbursement and accountable care. The world of healthcare is changing so rapidly and so is the role of case management in that world!

Data Integrity: FDA, WHO and EMA's Requirements

The objective of this two day ComplianceOnline seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program and how to maintain Quality Systems that minimize these issues. This seminar is designed to assist in assuring that your organization is maintaining itself within cGMP compliance.

This three-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

The Veterinary Drug Approval Process and FDA Regulatory Oversight

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.

BSA/AML/OFAC Risk Assessments - Are You Doing Them Correctly

This Bank Secrecy Act risk assessment seminar will highlight BSA best practices that are being acknowledged and recognized by regulators and examiners and will discuss each risk assessment area. Attendees will learn how to conduct a comprehensive review of their current organization’s BSA/AML/OFAC risk assessment.

Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations.

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters

The objective of this on-line, interactive two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn their current and updated status and to confirm that those Chapters being utilized are used correctly.

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic.

Designing and Sustaining New and Existing Product Stability Testing Program

This Virtual Seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program.

Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing

In this two day workshop conference you will learn the different global agencies expectations of equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient.

21 CFR Part 11, Data Integrity, and Computer System Validation

The course will begin with an overview of the current regulations (e.g. 21 CFR 820.70(i), 21 CFR Part 11, 21 CFR 211.68), standards (e.g. ISO 13485), guidance (e.g. FDA’s General Principles of Software Validation, AAMI/ISO TIR80002-2), methods (e.g. V-model, Agile Scrum), and terminology governing the design, development, validation, release, and maintenance of regulated software systems.

Laboratory Inspection and Auditing

Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control.

Method Development and Validation for Assays Supporting Testing of Biologics

The format of the seminar offers an examination of current best practices as well as time to dissect examples of documentation with emphasis on beneficial systems to consider. Scientists who attend this 2-day virtual seminar will gain knowledge that will be beneficial in helping to achieve well-controlled validated methods.

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology.

Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada

This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.

Change Control Best Practices - Avoiding Unintended Consequences of Changes

This is a practical how-to course, designed to provide participants with skills they can immediately apply to change controls within their own organizations. Case studies will allow participants to practice skill sets in cooperation with the instructor.

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

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.

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies.

TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties

This IRS regulatory compliance training will explain the TIN Matching System best practices to eliminate form 1099 reporting errors. It will also provide you the tools to effectively handle B- Notices in order to avoid fines and penalties.

BSA/AML Contextual Awareness of High Risk Customers

This webinar will highlight the steps to identify and evaluate high-risk customers. Learn how to perform BSA, AML risk assessments.

Data Integrity Compliance for Computer Systems Regulated by FDA

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.

Are the financial transactions within your organization subject to money laundering risk? Do you have a robust internal controls program that focuses on mitigating the greatest AML/Fraud risks? Are your employees aware of the red flags within all financial transaction business processes and know what to do if they find unusual or suspicious activity?

Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices

This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls!

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

Radiation Sterilization of Medical Products - Beyond the Basics

This two day highly interactive course will cover all aspects of radiation sterilization validation, materials selection and processing implementation. This workshop has been designed to help attendees learn the ins and outs of all the radiation modalities, materials selection, and validation of the sterilization process per ISO 11137.

Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions

The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment.

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

The Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan. Health Canada has now made the MDSAP process mandatory for all licensed products in Canada.

Healthcare Fraud Webinar - False Claims, Stark, Anti-Kickback Statute, and Civil Monetary Penalties Law

This webinar will explain the Civil Monetary Penalties Law (CMP) and its mandatory and permissive exclusions and penalties. It will also cover obligations under EMTALA, violations of the Anti-Kickback Statute and Stark including amendments under the PPACA.

Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

This webinar will discuss the basic principles of P&PC, specifically as required by the FDA.

The 6 Most Common Problems in FDA Software Validation and Verification

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

The Drug Development Process from Concept to Market

This course is designed to cater for employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process. The course starts by considering the global pharmaceutical market, important therapeutic areas and the roles of different pharmaceutical professionals in the development process, as well as a definition of drugs and medical devices.

Conducting Sound Sexual Harassment Investigations

This course is designed to provide HR practitioners of all levels with a step-by-step process for conducting sexual harassment investigations in the work environment that will protect employees and the company as well.

Pharmaceutical Data Integrity

This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications.

Outlook: Master Your Mailbox - Inbox Hero Inbox Zero

​This training session focuses on the email aspect of Outlook. In this session you'll learn how, used in the right way, Outlook can save you time, help you to gain more control over your mailbox, improve your response time and allow you to keep up with the never-ending stream of critical actions and due dates.

FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat

FDA regulated industries can prophet by understanding the regulatory power of FDA and incorporating this knowledge into their daily routine.By doing your homework and putting simple principles to work you can minimize the negative effects of FDA’s power and put everyone in your organization at ease.  Why live in fear when you can rest at night knowing you are ready?

California Meal and Rest Breaks: What You Don't Know Can Cost You

This course is designed to provide you with a practical foundation for understanding the law. It includes guidelines for how to properly create and administer your own meal and rest period policy. Or, if your company already has its own policy, then this information can help you review your existing policy as well as the procedures and practices in “real life” daily operations.

In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions

The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation

The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system.

ComplianceOnline Banking Summit 2016 | Risk Management and Data Security

Banking (BFSI) Summit 2016 covers industry challenges related to risk governance, digital currencies, mobile banking, cyber security, insider fraud & much more.

Pharma Summit 2016 – Risk Control & Compliance

The ComplianceOnline Pharma Summit 2016 - Risk control & Compliance aims to bring together FDA, Experts, Leaders and Veterans to discuss the most important challenges of Biotech, Pharma industry.

ComplianceOnline Medical Device Summit - 2015

ComplianceOnline Medical Device Summit - 2015.