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Upcoming Events

Webinar Compliance

Pragmatic and Effective Vendor Qualification Program for cGMP Compliance

Wilmington, DE
Regulatory agencies such as US FDA and others expect pharmaceutical companies to treat their suppliers and contractors as an extension of their own operation. Hence oversight of their vendors’ quality compliance is of para... read more

Risk Management in Clinical Research

Wilmington, DE
The premise behind RBQM is that monitoring quality can be improved by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization an... read more

FDA and EU Process Validation and Equipment Qualification

Newark, NJ
The FDA’s Quality System Regulation (QSR) is clear on the importance of equipment controls – you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes.... read more

Getting Your Medical Device Software 510(k) Ready

Chelsea, MA
One of the most common reasons that organization submitting a 510(k) for Software Enabled Medical Devices or Software as a Medical Device fail to obtain approval by the FDA is due to deficient or missing documentation. Thi... read more

Diversity and Inclusion 101

Los Angeles, CA
Diversity and inclusion are common buzzwords these days but few understand what they really mean or entail. In this workshop, we will explore what diversity and inclusion REALLY are as well as common myths and misconceptio... read more

Continued Process Verification – A Systematic Approach

Wilmington, DE
The FDA’s Process Validation Guidance calls for “Continued Process Verification” in Stage 3 of the Guidance which focuses on continual assessment of process performance and product quality throughout the life of the produc... read more

Ensuring your Site is Ready for an FDA Inspection

Wilmington, DE
An FDA inspection can be a stressful and challenging experience. This webinar will help you understand the basics of FDA inspections so you can be well prepared. We will discuss how to prepare for an inspection, what to do... read more

Project Management for HR

Wilmington, DE
These days a huge role of HR Management is managing projects. Today’s projects often include technology considerations and cross-functional teams and grow increasingly complicated with each new project.

Excel VBA 101 – Take Automation Beyond the Macro Record

Wilmington, DE
Although Excel has a Macro Recorder for automating tasks and processes, there’s a limit to what the Macro Recorder can do. So where the Macro Recorder’s functionality ends, VBA takes over.

Interviewing Skills for Supervisors – Keys to Conducting Effective Candidate Interviews

Wilmington, DE
Going beyond the basics of what not to ask interviewees, the Interviewing Skills for Supervisors: Keys to Conducting Effective Candidate Interviews webinar focuses on what you really need to know to conduct revealing inter... read more

Avoid the Most Common Sources of ISO 9001 on conformances with the Process Approach

Wilmington, DE
Penny Ouellette’s “ISO 9001:2015 Implementation: The Good, the Bad and the Trending” (Quality, November 8 2018) provides a valuable list of the most frequent clauses that are cited in ISO 9001:2015 findings. These are:

EU Medical Devices Regulation – CE Mark Expiration and the EU Refusal of Your Exports

Wilmington, DE
FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between FDA and the EU include premarket authorization (CE Mark), complaint investigations, postmarket surveillance... read more

HR Files Know-How – Keeping Your Employment Records (and You) Organized

Wilmington, DE
HR professionals know that a major part of their responsibility is keeping the company’s personnel files organized – for many legal reasons, but also because it helps to keep your operations go smoothly.

3-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

Wilmington, DE
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... read more

Emotional Intelligence in Leadership

Wilmington, DE
Soft skills are one of the most sought-after skill sets in the workforce today. Yet few opportunities to understand the theories and best practices for emotional intelligence are available. In this webinar, we will explore... read more

FDA Rules for Pharmaceutical Analytical Method Validation

Wilmington, DE
FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discus... read more

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Wilmington, DE
Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states:

Root Cause Analysis and CAPA using 8-D Problem Solving Method

Wilmington, DE
Corrective and Preventive Action (CAPA) has been a mandatory element of quality management systems for decades. Identification and elimination of a problem’s root cause makes it unnecessary to solve the same problem more t... read more

Statistical Justification for Sample Size

Wilmington, DE
Almost all manufacturing and development companies perform at least some process validation studies, but it is difficult to decide how many Lots to include in the study and how large the Sample per Lot should be.

The Requirements and Responsibilities of a HIPAA Security Privacy Officer

Wilmington, DE
Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willf... read more

How to Properly Manage a Regulatory Inspection

Wilmington, DE
The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit i... read more

HR Documentation 101 – How to Produce High Quality, Defensible Employment Documentation

Wilmington, DE
What an employer does document, what it does not document and the manner of use of the documentation are critical elements in determining whether their records show compliance with the law(s) – or not.

Supplier Qualification – Important Part of Quality Systems and Supply Chain Management

Wilmington, DE
This webinar is important to the industry as all the regulations require quality assurance of the materials, components, and services that impact or are used for the final product configuration. In addition, supplier quali... read more

SOP’s for Bioanalytical Methods Validation

Wilmington, DE
Bioanalytical assays are used in a variety of laboratory contexts, from clinical laboratories, to research and development, to quality control and manufacturing. These laboratory assays have become crucial to the regular o... read more

Good Manufacturing Practices 3 Hour Virtual Seminar

Wilmington, DE
What are Good Manufacturing Practices? They are a set of practices that are required to comply with regulations and industry standards that insure that your products are effective as claimed and are pure and defect free. G... read more

AP & Payroll Working Together

Wilmington, DE
These 2 departments work together a lot and it is important that it is clear on who pays what, plus who reports what to the IRS. Discussion on AP & Payroll Functions and who should own responsibility of each including payi... read more

Quality by Design (QbD) in Pharmaceutical and Medical Device Manufacturing

Wilmington, DE
Incorporating a strong quality system during pharmaceutical drugs and medical device design and development by understanding the unique product design and development requirements for final approval and marketing of medica... read more

3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit

Wilmington, DE
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will help you understand the FD... read more

Data Quality Culture and Building a Corporate Data Integrity Plan

Wilmington, DE
The purpose of the webinar is to bring attendees attention to behaviors and conducts that companies should consider when considering the implementation of a corporate data integrity plan.

What to Do If an Applicant has a Criminal History?

Wilmington, DE
“Ban the box” continues to occupy a large portion of recruiting discussions, even in municipalities that haven’t enacted these regulations.

3-Hour Virtual Seminar on Master Validation Plan – The Unwritten Requirements

Wilmington, DE
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Valid... read more

Employee Expense Reimbursement Fraud – Detection, Prevention and Deterrence

Wilmington, DE
This 90-minute webinar will summarize the main types of reimbursement fraud to be alert to, and include an analysis of several “real life” case studies. It will explain how to identify the red flags of possible reimburseme... read more

Implementing a Metrics Program – Uncovering and Overcoming the Challenges

Wilmington, DE
Recently the FDA released their draft Guidance for Industry entitled “Request for Quality Metrics”. Much discussion of quality metrics has ensued regarding this guidance and its elements. This presentation provides an inte... read more

HIPAA and Health IT – What You Need to Know as a Business Associate

Wilmington, DE
This training program will highlight the HIPAA Security and Privacy Rules and analyze the consequences of being a business associate. It will also examine what a HIPAA compliance program and a HIPAA risk management plan en... read more

Statistics and Data Analysis for Auditors

Wilmington, DE
“The goal is to transform data into information, and information into insight” – Carly Fiorina, former President of Hewlett Packard

Validation and Control of Excel® Spreadsheets in Regulated Environments

Wilmington, DE
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11... read more

Establishing and Regaining Control of Cleanroom

Wilmington, DE
This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringi... read more

Communicate For Results – Key Strategies for Getting Things Done

Wilmington, DE
You know that effective communication skills are vital to your success in business—but how much time do you devote to strengthening your abilities? Poor, ineffective communication can have wide-ranging negative consequence... read more

Excel as a Business Intelligence Tool – Pivot Tables

Wilmington, DE
Microsoft Excel Pivot Tables are one of the most powerful tools in Excel’s data analysis and Business Intelligence (BI) armoury.

IQ, OQ, PQ in the Verification and Validation Process

Wilmington, DE
Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover what processes needed to be validated and what steps you need to take to validate processes. You’ll also learn the ... read more

FDA’s Risk Evaluation and Mitigation Strategy (REMS)

Wilmington, DE
Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the m... read more

The New Managers Toolkit to Instant HR Proficiency

Wilmington, DE
As the old saying goes an ounce of prevention is worth a pound of cure. Training your managers, especially new managers in the basics of HR compliance is the easiest, fastest, most helpful, and downright cheapest thing a c... read more

FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

Wilmington, DE
The United States Food and Drug Administration (FDA) can approve small molecule drugs and some biologics under the regulatory pathway 505(b)2.

HIPAA Compliance Monitoring and Auditing

Wilmington, DE
We’ll use real-world examples to help explain the Privacy Rule, which governs patient rights and disclosure of protected health information (PHI), We’ll explain what’s meant by covered entities (CE), business associates (B... read more

3-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries

Wilmington, DE
This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Valid... read more

NCMR Simplified – A One-Form, Easy-To-Complete, Method For Simplifying Your NCMR Process

Wilmington, DE
This presentation will cover the FDA regulations (21 CFR Subpart I) regarding NCMR, how NCMR should be integrated into your CAPA system, how to best approach NCMR (including initiation, segregation, evaluation, investigati... read more

Prevent Payroll Errors – Effective Root Cause Analys

Wilmington, DE
Identify and Prevent Common Payroll Errors With Effective Root Cause Analysis. Payroll departments are facing increasing pressure to do more with less. Technology is now an integral part of our daily lives, and payroll is ... read more

Risk Analysis and HACCP

Wilmington, DE
This webinar will discuss the use of microbiological risk analysis in the development of HACCP programs for food production. We will discuss the changing landscape of microbial concerns and the importance of the team appro... read more

Using Learning Management Systems (LMS) to Develop Pharma Training – Rewards and Challenges

Wilmington, DE
Learning Management Systems (LMS) are important tools for assuring and demonstrating that pharma companies maintain their staff training, and their efforts are up-to-date. These systems often boast great functionality but ... read more

6-Hour Virtual Seminar on Project Management for Non-Project Managers

Wilmington, DE
This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction f... read more

Data Governance for Computer Systems Regulated by FDA

Wilmington, DE
Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realiz... read more

Interviewing Witnesses in Internal Investigations

Wilmington, DE
Many employers struggle to gather information during witness interviews in investigations. Many employees for a variety of reasons are reluctant to be involved and can be less than forthcoming. Friends of employees and tho... read more

Good Laboratory Practices (GLPs) vs GMPs – Comparisons and Contrasts

Wilmington, DE
According to the FDA, CFR part 58, good laboratory practices (GLPs) are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permi... read more

CAPA Simplified – A one-form, easy-to-complete, method for simplifying your CAPA Process

Wilmington, DE
This CAPA evaluation, implementation and integration webinar will discuss FDA regulatory requirements, how to evaluate your CAPA system, how to integrate with QMS and the best practices approach to initiation, evaluation a... read more

Equipment Qualification and Process Validation

Wilmington, DE
FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations ... read more

FDA’s 21 CFR Part 11 Add-on Inspections

Wilmington, DE
Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether in the pharmaceuticals, medical device, biologics or dietary supplements ind... read more

Project Management in Clinical Research

Houston, TX
This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research during the new drug develo... read more

How to Prepare Yourself for FDA’s on-going Part 11 Inspection

Wilmington, DE
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate in... read more

Solving Statistical Mysteries – What does the FDA want

Wilmington, DE
This webinar provides an overview of what it appears the FDA is looking for in the use statistics by taking illustrative examples from warning letters and industry experiences and approaches that have worked in a variety o... read more

The Employer’s Guide to Severance Arrangements – EEOC, ACA and ERISA

Wilmington, DE
Have you ever terminated an employee or handled the aftermath of an employee termination? Do you offer severance pay? Do you use severance agreements? When done properly, severance arrangements can be an extremely valuable... read more

4 Hours Virtual Seminar – Change Control According to GxP and GMP Requirements

Wilmington, DE
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitabl... read more

Adaptive Communications – Overcoming Communication

Wilmington, DE
Do you have to communicate with people who make you want to pull your hair out (for those of us who still have hair)?

Four Steps to Effective Communication – DISC as Your Powerful Leadership Guide

Wilmington, DE
This course is designed to provide you with an enlightening overview of the DISC model, a behavioral assessment that measures individuals’ natural, hard-wired behavioral style. This style remains quite stable over our adul... read more

What is the harm in that? Risk Management

Wilmington, DE
A Highly regarded talk during recently held ASQ World Conference on Quality and Improvement. This course is meant to be a needed introduction to risk management for a broader range of professionals.

Expedite Excel with Hidden Shortcuts

Wilmington, DE
Excel expert David Ringstrom, CPA is fond of stating “Either you work Excel, or it works you!” In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You’ll u... read more

Power Analysis for Sample Size Calculations

Wilmington, DE
In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation. Also attendees will get work examples in the free to use G*Power software. S... read more

Quality Control for Microbiological Media and Reagents

Wilmington, DE
This webinar will help you develop a quality control program that fits your microbiological laboratory’s needs. We will explicitly not cover any serological, immunological or molecular tests.

Regulatory Compliance Auditing for Pharma Manufacturers

Raleigh, NC
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Compliance auditing is the process of checkin... read more

Effective and Pragmatic Vendor Qualification Program for cGMP Compliance

Los Angeles, CA
Vendor qualification program must be customized for the type of products one manufactures, so that the program will be effective, robust, pragmatic, but at the same time, it will meet the applicable regulatory agencies’ re... read more

Effective Contamination Control and Environmental Monitoring Program

Wilmington, DE
This webinar will provide an overview of environmental monitoring and provide aspects of contamination control. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanline... read more

FDA Off-Label Promotion Guidelines

Wilmington, DE
The United States Food and Drug Administration (FDA) regulates labeling and advertisement for prescription drugs and medical devices among other things. The advertising for nonprescription or over-the-counter (OTC) drugs f... read more

Stress Free Public Speaking for HR Professionals

Wilmington, DE
This course will teach you to speak in public without any fear to hold back your career or even without damaging your image, All of you can learn to give confident presentations after attending this session.

FDA (QSIT) Audits – Good Preparation Practices

Wilmington, DE
Large and small medical device companies have a challenge in preparing for and dealing with FDA audits. Quality and Manufacturing personnel in charge of creating and maintaining your quality management system for all of th... read more

How to Apply for a Breakthrough Therapy Designation and Win It

Wilmington, DE
This webinar, presented by a leading regulatory affairs expert with successful BTDs, discusses FDA expectations from BTD requests, the best practices to write a BTD request, and pros and cons of applying for a BTD. The ses... read more

Risk-Based Environmental Monitoring (EM) Program

Wilmington, DE
Environmental Monitoring (EM) programs for pharmaceutical manufacturing are consistently moving toward a risk-based approach, using proactive data analysis to control environmental factors in a manufacturing environment. I... read more

Top Process Validation Mistakes – And How to Avoid Them

Wilmington, DE
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to ta... read more

Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

Wilmington, DE
The seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans.
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Past Events

3-Hour Virtual Seminar on Safety Audits and Pharmacovigilance (PV) Inspections

3-Hour Virtual Seminar on Safety Audits and Pharmacovigilance (PV) Inspections

Wilmington, DE
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 ...
Wednesday, April 17 2019 12:00 PM 3:00 PM

Root Cause Analysis

Root Cause Analysis

Wilmington, DE
When you have a non-conformance in the laboratory, how do you approach it? Do you jump in and start treating the symptoms? Or do you stop to consider whether there’s actually a deeper problem that needs your attention? Root Cause Analysis (RCA) is a popular and often-used technique that helps p...
Tuesday, April 16 2019 1:30 PM 2:30 PM

ANDA Submission and GDUFA Final FDA

ANDA Submission and GDUFA Final FDA

Wilmington, DE
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 ap...
Tuesday, April 16 2019 1:00 PM 2:00 PM

Monitoring and Validation of Pharmaceutical Water Systems

Monitoring and Validation of Pharmaceutical Water Systems

Wilmington, DE
This webinar will discuss the FDA requirements for design, validation and monitoring of pharmaceutical water systems. There are many different types of pharmaceutical waters and each must be fit for its intended use. Pharma water must be controlled for impurities. Pharma water systems must be des...
Tuesday, April 16 2019 1:00 PM 2:00 PM

Excel Spreadsheet Auditing Techniques

Excel Spreadsheet Auditing Techniques

Wilmington, DE
You’ll learn valuable techniques you can use to verify the integrity of even the most complicated Excel spreadsheets when you participate in this webcast. Excel expert David Ringstrom, shows you how to use Excel’s formula auditing and error-checking tools, identify duplicates in a list, monitor t...
Monday, April 15 2019 3:00 PM 4:00 PM

How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program

How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program

Wilmington, DE
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related t...
Monday, April 15 2019 1:00 PM 2:15 PM

Dealing with Toxic People

Dealing with Toxic People

Wilmington, DE
There are challenges in dealing with people who bring toxicity to the interaction. One challenge is managing the impact it has on us – the other challenge is how to respond effectively – in essence – in ways that continue to allow us to get the job done and maintain a working relationship. In th...
Friday, April 12 2019 1:00 PM 2:00 PM

HIPAA Breaches – How to Reduce Human Error

HIPAA Breaches – How to Reduce Human Error

Wilmington, DE
More than 175,000,000 individuals have been affected by HIPAA data breaches. During the last year, 78% of HIPAA breaches are caused by human error. That means almost all of those breaches may have been prevented. Does your organization have the required safeguards in place? Have you trained your ...
Friday, April 12 2019 1:00 PM 2:30 PM

Lean Six Sigma and ISO:2015

Lean Six Sigma and ISO:2015

Wilmington, DE
This course teaches any employee the Lean Six Sigma philosophy and how to apply it in their job on a day-to-day basis. Participants will learn each phase of Six Sigma’s DMAIC methodology and their use as a part of the continuous improvement program. Students will understand how implementation of ...
Friday, April 12 2019 1:00 PM 2:00 PM

Medical Device Laws and Regulations in Asia – Part 2 – India, Japan, and Korea

Medical Device Laws and Regulations in Asia – Part 2 – India, Japan, and Korea

Wilmington, DE
This webinar is intended to help you get familiar with medical device laws and regulations in India, Japan, and Korea. The medical devices are currently one of the fastest growing industries. The current knowledge and accurate understanding and adequate interpretation of global medical device la...
Friday, April 12 2019 1:00 PM 2:00 PM
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