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Upcoming Events

Webinar Compliance

Project Management for Non-Project Managers – 3 Hours Virtual Seminar

Wilmington, DE
It is not possible to present a complete treatment of project management in the span of 3-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of... read more

Measurement Systems Analysis -

Wilmington, DE
Calibration (accuracy) has been traditionally required by ISO 9001, but measurement systems analysis (precision) has not – although it has been an element of the automotive standard IATF 16949 ever since the latter was QS ... read more

Surviving in an Emotionally Toxic

Wilmington, DE
Are you feeling Frustrated? Exhausted? – trying to deal with all the emotions that swirl around in your workplace. Feeling like you just don’t know what to do? Sometimes it’s the same person you have to deal with day in an... read more

Understanding and Implementing a Quality by Design (QbD) Program-

Wilmington, DE
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product qu... read more

Aseptic Processing and Validation

Durham, NC
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Analytical Instrument Qualification and Validation – Understanding Use of Excel and FDA Audit Preparation

Richmond, VA
In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and i... read more

3 hour Virtual Seminar on HIPAA – How to Put a Comprehensive Compliance Program in Place

Wilmington, DE
Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and proc... read more

Statistical Power – Understanding, Calculating, and How to Effectively Use it

Wilmington, DE
Statistical power is an indicator of the ability of a test of significance to “detect” a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sampl... read more

Analytical Method Transfer According to USP General Chapter-1224

Wilmington, DE
This webinar presents a logical, risk-based approach to method transfer based on existing knowledge of method characteristics and effective transfer documentation. The transfer of analytical methods is an important element... read more

Medical Device Software Compliance

Wilmington, DE
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll le... read more

Diversity and Inclusion – Cultural Competence in the Workplace

Wilmington, DE
Cultivating a work environment characterized by cultural competence is critical for success in the modern business environment. Today’s workforce is more diverse now than it has ever been in the past, and is likely to cont... read more

Is it Microbiological Method Verification or Validation, or Just Semantics?

Wilmington, DE
Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often... read more

The Requirements and Responsibilities of a HIPAA Security

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

Outlook – Master your Mailbox – Inbox Hero Inbox Zero

Wilmington, DE
For most business users (and many home users too), Microsoft Outlook has become the standard application for managing emails, calendar appointments and to-dos. With an abundance of features and versions for desktop and mob... read more

3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs

Wilmington, DE
This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union’s M... read more

SR Letter 11-7 – Supervisory Guidance on Model Risk Management

Wilmington, DE
This training program will detail why SR Letter 11-7 has become the gold standard for model risk management, with its principle being adopted not only by banks but also virtually all U.S. financial institutions.

ISO:2016 Requirements and Compliance to Latest Updates

Wilmington, DE
Key changes to the ISO 13485:2016Effective Gap Assessment with ISO 13485Updating your procedures to ensure compliance on an ongoing basisObserving every individual element that had been enhanced under ISO 13485: 2016Succes... read more

Using HR Analytics – The KISS (Keep It Simple Silly) Method

Wilmington, DE
This webinar will highlight how employers who has a lot of data about their employees can effectively find out related and un-related data, how to process it for and use as a simulator tool, create performance and engageme... read more

Measurement Uncertainty in Microbiology

Wilmington, DE
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using... read more

3 Hours Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations

Wilmington, DE
This seminar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the atte... read more

How to Identify Leaders Within Your Organizations

Wilmington, DE
Identifying and developing talented employees with the potential to become supervisors, department managers and possibly even members of your company’s executive leadership team is a critical aspect of strategic staffing. ... read more

Additive / 3D Printing Manufacturing and Its Regulatory Issues

Wilmington, DE
Additive Manufacturing (AM) or 3D Printing for manufacturing of medical devices is a new and rapidly expanding field, with rapidly expanding regulatory concerns. What is it? What are US FDA stated concerns? This webinar wi... read more

Effective Pharmaceutical GMP Audits and Self-Inspectionss

Wilmington, DE
Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and... read more

Monitoring and Auditing – E/M Auditing Fundamentals

Wilmington, DE
This E/M Auditing webinar will explain how to get start with an auditing program in your healthcare organization and expand your knowledge of evaluation and management coding and auditing that will help you to increase rev... read more

Criminal Background Checks in the Hiring Process

Wilmington, DE
Most of your employees are likely to be honest, reliable employees. At the same time, hiring employees always involves at least some risks. Are they honest? Are they reliable? Are you, your employees and the public safe if... read more

SOP Writing, Training and Compliance in the Pharmaceutical Industry

Raleigh, NC
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, and are a vital component of ensuring compliance with regulatory ag... read more

Technical Report Writing and Statistical Analysis

Newark, NJ
Clear, unambiguous technical reports and procedures are of vital importance in the pharmaceutical industry. They are used to communicate the outcomes of product development work and investigations, and may be reviewed by t... read more

Cleaning Validation Program, Procedures, Principles and Regulatory Requirements

Houston, TX
This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course ... read more

Good Clinical Data Management Practices

San Diego, CA
Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO). CDM involves all aspects of collecting, processing, and interpreting information. There are many types of co... read more

510(k) Update – How to Format Succinct and Comprehensive - Hours Virtual Seminars\

Wilmington, DE
This seminar will discuss what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increas... read more

CMO Supplier Quality Agreements – How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture

Wilmington, DE
A contract between a GMP Contract Manufacturer and a pharmaceutical firm is a Quality Agreement and it details responsibilities of both parties by assuring the safety, efficacy and quality of the drug that has been manufac... read more

Good Documentation Practices to Support Computer System Validation

Wilmington, DE
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or... read more

Writing Job Descriptions – Easy and Practical Process

Wilmington, DE
Considering all the ways job descriptions are used in today’s workplace, it is critical that an employer describe a job accurately. It is imperative that a job description clearly explain what a person in a given position ... read more

Creating a Payroll Manual – Putting Your Procedures into Writing

Wilmington, DE
Technology is increasingly becoming part of our daily lives, and payroll is no exception. Payroll departments everywhere are being asked to do more with less and by leveraging technology to do payroll tasks. Now that day-t... read more

Patient Rights, Medical Records and HIPAA – What You Need to Know as a Healthcare Provider

Wilmington, DE
Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and proc... read more

How to Write Effective 483 and Warning Letter Responses

Wilmington, DE
In this regulatory inspection webinar attendees will learn the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential... read more

Sterilization Processes – The Methods, Parameters

Wilmington, DE
The sterilization of products or components is achieved through a variety of methods. This webinar will cover the common methods of sterilization such as saturated steam, radiation, dry heat, ethylene oxide, the terminolog... read more

AML/OFAC Risk Assessment – The Cornerstone of an Effective Compliance Shop

Wilmington, DE
In this training program, attendees will learn to define AML/OFAC risk assessment and the importance of increased regulation of these assessments. The program will additionally focus on AML/OFAC risk assessment best practi... read more

FDA’s New Enforcement of 21 CFR Part 11

Wilmington, DE
FDA continues to enforce Part 11 through its ongoing 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... read more

Packaging and Labeling in Pharmaceutical Product Development

Wilmington, DE
Occupying a critical position in the success or failure of any pharmaceutical product launch, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities ... read more

GMPs for Medical Marijuana Production Operations Cannabis

Wilmington, DE
Legal marijuana is one of the fastest-growing industries in the U.S., with more and more states starting to legalize medical marijuana to varying levels of control and regulation. However, the federal government has not ye... read more

Quality System Regulations for Combination Products

Wilmington, DE
This webinar will explain the quality system regulations (QSR) for combination device manufacturers to ensure compliance with for FDA and ISO 13485 requirements. It will also provide practical tips to sustain the growth of... read more

The Most Effective Way to Motivate Staff

Wilmington, DE
If you would like staff that are more motivated, set and achieve goals and self-regulate, understanding how motivation occurs at a very deep level is essential.

The FDA Inspection Process – From SOP to 483

Wilmington, DE
This FDA Inspection process training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

Tips and Techniques for Effective Performance Appraisals

Wilmington, DE
This webinar emphasizes what managers and supervisors need to know about employee performance appraisals. It covers the role and importance of providing employees with ongoing feedback and periodic formal evaluations, alon... read more

Zero Acceptance Sampling to Reduce Inspection Costs

Wilmington, DE
Inspection is a necessary but non-value-adding activity whose purpose is to protect the customer from poor quality. We should therefore do as little as possible, upon condition that our inspection plan meet the customer’s ... read more

Trial Master File Requirements and Essential Regulatory Document

Wilmington, DE
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practic... read more

Using Metrics to Monitor and Improve Your Quality System

Wilmington, DE
Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders:

EU and US GMP/GDP – Similarities and Difference

Wilmington, DE
Compliance with GMP and GDP regulations is essential for medicinal product development, manufacturing and distribution companies. Despite the recent Memorandum of Understanding between FDA and EMA, the two major regulatory... read more

FDA Regulation of Over-the-Counter (OTC) Drugs

Wilmington, DE
Both new and experiences OTC manufacturers will benefit from a review of the various FDA rules for OTC drugs. Knowledge of these rules and regulations is important for staying out of trouble with the FDA, which should be o... read more

Leave Abuse under FMLA, ADA and Workers’ Comp – How Employers Can Deal with the Most Outrageous Excuses

Wilmington, DE
This training program will focus on employee leave abuse under FMLA, ADA, and Workers’ Comp. It will help participants get a working knowledge of how an employer can minimize a company’s exposure to employee abuse of famil... read more

The DIOM – A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs

Wilmington, DE
This webinar will provide valuable insight to design assurance and quality assurance engineers looking to simplify or condense design development activities into one document for easier traceability. This webinar is also i... read more

GMP Audit of API Manufacturers – From Start to Finish and Then Some!

Philadelphia, PA
With an ever increasing practice of contracting out services and the demand of APIs for numerous drug products, the assurance of quality practices for their manufacture is an area of concern for all parties involved, inclu... read more

Ensuring Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists

San Diego, CA
Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors. Any violations from the vendors can cause serious problems for the manufacturers. Choosing a foreign vendor i... read more

Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

San Diego, CA
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or... read more

Integrating Lean and Project Management

Wilmington, DE
Whether you work on projects or improvement initiatives, you will benefit from this session that integrates the commonalities of Lean and Project Management. Both methodologies are focused on leading some type of change in... read more

Successful Change Control Management

Wilmington, DE
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical... read more

Auditing Call Reports – Best Practices for Documentation and Review

Wilmington, DE
With regulatory agencies increasingly relying on the Call Report as an effective way to monitor and remotely supervise banks, there is greater emphasis on Call Report accuracy. In addition, regulators are more frequently i... read more

Managing Product and Process Risk through Failure Mode and Effects Analysis (FMEA)

Wilmington, DE
Conducted early in the process development cycle, the Failure Modes and Effects Analysis tool is used to identify risks and then adjust the manufacturing or service process to reduce the identified risks and improve qualit... read more

Process Capability Analysis using Confidence

Wilmington, DE
All manufacturing and development companies perform testing and/or inspections that involve concluding whether or not a product or lot is acceptable vs. design or QC specifications. Such test/inspections may occur during d... read more

Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

Wilmington, DE
cGMP drug products rely on the bacterial Endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its applicatio... read more

Handling Terminated Employees – Best Payroll Practices

Wilmington, DE
This webinar with expert speaker Dayna J. Reum, will go into detail that employers face when paying terminated associates. Dayna will review everything from final pay to stock options and payments to employees that may occ... read more

Practical Excel – Executing Spreadsheet Internal Control

Wilmington, DE
You’ll learn from Excel expert David Ringstrom, CPA, how to establish internal controls within your Excel spreadsheets in this valuable presentation. David demonstrates how to implement several Excel features and functions... read more

EO Sterilization Validation / Revalidation per ISO

Wilmington, DE
This webinar will outline the required elements of a successful ethylene oxide (EO) sterilization validation process for medical devices as required by ISO 11135:2014. Hardware / chamber and software considerations and req... read more

Implementation of a Successful Technology Transfer Proces

Wilmington, DE
This training will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation. It ... read more

Millennials and Generation Z – Reducing Attrition and Unlocking Your Company’s Productivity

Wilmington, DE
This course will walk you through an enlightening discussion about the myths surrounding Millennials and Generation Z with the aim of providing a fresh point of view about their motivations and values. You’ll learn how the... read more

Project Management For Human Resource Professionals-

Indianapolis, IN
When HR becomes a true business partner, along with that comes the responsibility to understand project management methods when working on projects. These days a huge role of HR Management is managing projects and vendors.... read more

Stop Wasting Your time! Write SOP’s and Work Instructions that Work

San Diego, CA
Standard Operating Procedures and work instructions are essential to the effective and compliant running of any regulated business. You primarily need these documents to meet the regulatory requirements of essentially ever... read more

Verification, Validation and Compliance for Medical Device Software

Wilmington, DE
Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device. Usually multiple factors affect the device performance. Therefore right validation is the key t... read more

Sampling – How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results

Wilmington, DE
The Pharmaceutical and Biotech industries are going through tremendous changes that have been increased by the recent global financial challenges. The FDA is promoting the use of Quality-by-Design (QbD) as an approach for ... read more

Best Practices For A Compliant, Lean Supplier Management Program

Wilmington, DE
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier manageme... read more

Evolving from #MeToo – Sexual Harassment Prevention in 2019

Wilmington, DE
With sexual harassment cases costing business tens of thousands and bringing in over a hundred million dollars in legal fees the cost is both fiscal and social. In this session we will explore the history and underlying is... read more

Analytical Method Validation and Transfer

Wilmington, DE
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring... read more

FDA Regulations for Pharmaceutical Current Good Manufacturing Practice (cGMP)

Wilmington, DE
This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning Letters and Inspectional Observations will be used as examples of ... read more

In Depth Testing of Computer Systems Regulated by FDA

Wilmington, DE
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related p... read more

Valid Statistical Rationales for Sample Sizes

Wilmington, DE
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen samp... read more

Data Integrity, Quality Metrics and Data Analytics

Chelsea, MA
The use of data has been part of the FDA’s guidance and regulations for many years. Recent uses include Quality by Design, Process Analytical Technology, Process Validation, Data Integrity and Quality Metrics. Advances in ... read more

Audit Like the FDA – Effective Internal Audit Program

St. Paul, MN
This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerfu... read more

Effective Cleaning Validation Procedures – Best Practices

Wilmington, DE
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols a... read more

Internal Audit – How Best to Perform Them

Wilmington, DE
The term “audits” and what it implies, whether performed by regulatory auditors, internal audit teams or third party customers, often invokes both anxiety and questions as to how best to prepare for them. The more a compan... read more

Medical Device Laws and Regulations in Asia – 2 Part Web-Series

Wilmington, DE
This 2-part webinar series is intended to help you get familiar with medical device laws and regulations in Asian countries. Module-1 will focus on China and Module-2 will focus on India, Japan, and Korea.

Medical Device Laws and Regulations in Asia – Part 1 – China

Wilmington, DE
This webinar is intended to help you get familiar with medical device laws and regulations in China.

Sterile Filtration of Pharmaceutical Products – Validation and Regulatory Requirements

Wilmington, DE
Proper validation of sterile filtration helps to ensure that the filter will reproducibly remove undesirable components or bioburden and will allow the passage of desirable components such as drug products. Thus, it is imp... read more

510(k) and PMA Refuse to Accept Policy

Wilmington, DE
This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability crite... read more

Changing Up Performance Reviews

Wilmington, DE
The only persons, who hate performance evaluations more than the employees receiving them do, are the supervisors who dread giving the evaluations. Yet most employees receive at least one performance evaluation each year. ... read more

Legally Terminating Employees – Complex Issues Which You Must Know

Wilmington, DE
Employers must terminate employees from time to time in order to run their businesses effectively. In today’s litigious world, terminating employees is an emotional and legal minefield for managers and supervisors. Even su... read more

Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting

Boston, MA
Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and ha... read more

Computer System Validation (CSV) Data Integrity for Clinical Trials Regulated by FDA

Richmond, VA
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or... read more

IEC 6230 for Medical Device Software

Wilmington, DE
This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company’s face whe... read more

Technical Report Writing

Wilmington, DE
Technical reports have a critical role to play in any company that relies on the clear communication of research. Poorly-written reports can make it difficult to assess the significance of experimental results, the next st... read more

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 ... read more

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... read more

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 cont... read more

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.

Process Capability Analys

Wilmington, DE
Process capability reflects the ability of a manufacturing process to meet specifications, and customers often request capability studies for this reason. This presentation will show how to perform a capability study, incl... read more

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 ... read more

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 Dr... read more

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. Pharm... read more

Root Cause Analysis

Wilmington, DE
When you have a non-conformance in the laboratory, how do you approach it?

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 t... 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

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
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Past Events

Practical Excel – How to Work Faster – 2 Part Web Series - Module 2

Practical Excel – How to Work Faster – 2 Part Web Series - Module 2

Wilmington, DE
In this follow-up session to Practical Excel: How to Work Faster, you’ll learn even more ways to save time and effort in Excel. Excel expert David Ringstrom, CPA, demonstrates shortcuts that allow you to streamline repetitive tasks and redundant data entry, embed lists you use frequently, transfo...
Friday, February 15 2019 3:00 PM 4:00 PM

3-Hour Virtual Seminar on Multi-State Payroll Compliance

3-Hour Virtual Seminar on Multi-State Payroll Compliance

Wilmington, DE
This seminar will review the state wage and hour laws along with how to apply them with the federal wage and hour laws. Determining taxation and proper reporting will be reviewing. Polices on multi state taxation and hands on case studies will be done to enhance learning. Special situations and t...
Friday, February 15 2019 1:00 PM 4:00 PM

Complaint Handling Best Practices – Compliance with FDA and ISO Regulations

Complaint Handling Best Practices – Compliance with FDA and ISO Regulations

Wilmington, DE
This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation and corrective action, as well as the ISO-specific implications. Also, discussed will be the best way to document cust...
Friday, February 15 2019 1:00 PM 2:00 PM

Design Verification, Validation and Testing for Medical Devices

Design Verification, Validation and Testing for Medical Devices

Wilmington, DE
Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485: 2016 have specific product verification and validation requirements that must be fulfilled in the medical device indu...
Friday, February 15 2019 1:00 PM 2:00 PM

Step-by-Step Process for Successful Sterility Failure Investigations

Step-by-Step Process for Successful Sterility Failure Investigations

Wilmington, DE
There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As s...
Thursday, February 14 2019 1:00 PM 2:15 PM

Project Management For Human Resource Professionals

Project Management For Human Resource Professionals

Los Angeles,, CA
When HR becomes a true business partner, along with that comes the responsibility to understand project management methods when working on projects. These days a huge role of HR Management is managing projects and vendors. All kinds of projects. Sometimes HR manages a project via a third party ve...
Thu, Feb 14 2019 8:00 AM Fri, Feb 15 2019 4:00 PM

Governance and Change Control according to GxP and GMP Requirements

Governance and Change Control according to GxP and GMP Requirements

Raleigh, NC
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 inevitable, it is essential that companies have a compliant and effective change con...
Thu, Feb 14 2019 9:00 AM Fri, Feb 15 2019 4:00 PM

3 Hours Virtual Seminar on 21 CFR Part Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

3 Hours Virtual Seminar on 21 CFR Part Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

Wilmington, DE
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall...
Wednesday, February 13 2019 1:00 PM 4:00 PM

Auditing Computer Systems for FDA and International Compliance

Auditing Computer Systems for FDA and International Compliance

Wilmington, DE
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic evaluation, vendor agreements, incident management and str...
Wednesday, February 13 2019 1:00 PM 2:15 PM

USP <1224> Transferring the Method to meet Regulatory Expectations

USP <1224> Transferring the Method to meet Regulatory Expectations

Wilmington, DE
The critical points of USP <1224> and the regulatory requirements required by the USP and FDA. USP <1224> is very specific on what is required for tech transfer of analytical methods as well as the responsibilities of the participating parties. In this webinar expert speaker Carl Patterson, will...
Wednesday, February 13 2019 1:00 PM 2:00 PM
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