Statistical Methods for Quality Improvement
Recorded Webinar
September 28, 2021 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Statistical Methods for Quality Improvement

Speaker(s): Steven Wachs

In this Statistical Method webinar you will learn the essential quantitative methods for assessing and ensuring product quality and compliance. This methods includes: Statistical Process Control, Proc...

Technical Writing- A Detailed Process
Recorded Webinar
September 30, 2021 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Technical Writing- A Detailed Process

Speaker(s): Robert Peoples

A Detailed Process provides step-by-step instructions for experienced Technical Writers go from the blank screens to the final written presentations. The webinar includes procedures for the creation o...

Compliance with the new EU Clinical Trial Regulation
Recorded Webinar
September 30, 2021 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Compliance with the new EU Clinical Trial Regulati...

Speaker(s): Dr Laura Brown

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonize procedures for carrying out cl...

EU-US biosimilar regulations - similarities and differences
Recorded Webinar
September 30, 2021 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

EU-US biosimilar regulations - similarities and di...

Speaker(s): Peter Wittner

The US is the largest and highest priced market for pharmaceuticals anywhere in the world. It therefore represents a very tempting target for companies wanting to launch copies of the very high-priced...

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
Recorded Webinar
October 13, 2021 | EST : 01:00 PM | PST : 10:00 AM

Advanced 60 min

Eliminate the Confusion - New Requirements for Cli...

Speaker(s): Dr Laura Brown

This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.

The FDA Inspection Process- From SOP to 483
Recorded Webinar
October 27, 2021 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

The FDA Inspection Process- From SOP to 483

Speaker(s): Jeff Kasoff

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the ...

Process Failure Mode Effects Analysis and Control Plan
Recorded Webinar
October 28, 2021 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Process Failure Mode Effects Analysis and Control ...

Speaker(s): William Levinson

Process failure mode effects analysis (PFMEA) is part of advanced quality planning (AQP) or advanced product quality planning (APQP), whose purpose is to plan quality into the product realization proc...

Is it Microbiological Method Verification or Validation, or Just Semantics
Recorded Webinar
November 17, 2021 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Is it Microbiological Method Verification or Valid...

Speaker(s): Michael Brodsky

This Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025 for laboratory accreditation in food/water micro...

Technical Writing- A Detailed Process
Recorded Webinar
December 01, 2021 | EST : 01:00 PM | PST : 10:00 AM

Advanced 60 min

Technical Writing- A Detailed Process

Speaker(s): Robert Peoples

Provides step-by-step instructions to produce excellent written presentationsLearn how to balance between being precise enough to cover the subject matter yet general enough to apply to other location...

Risk-based Design Control - The New Paradigm for Medical Device Design
Recorded Webinar
December 07, 2021 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Risk-based Design Control - The New Paradigm for M...

Speaker(s): Jose Mora

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a parti...

How FDA Trains Its investigators To Review CAPA and What You Should Do To prepare
Recorded Webinar
December 22, 2021 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

How FDA Trains Its investigators To Review CAPA an...

Speaker(s): Jeff Kasoff

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company’s CAPA system. What will ...

Best Practices in Preparation for an FDA Computer System Audit
Recorded Webinar
January 20, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Best Practices in Preparation for an FDA Computer ...

Speaker(s): Carolyn Troiano

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 hel...

Technical Writing- Best Practices For Everyday Use
Recorded Webinar
February 17, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Technical Writing- Best Practices For Everyday Use

Speaker(s): Robert Peoples

Technical Writing generally conforms to Good Documentation Practices (GDocP). This term describes standards to create and maintain documents. Most companies have in-house procedures that all documents...

Sterilization of Pharmaceutical Products and Medical Devices
Recorded Webinar
February 18, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Sterilization of Pharmaceutical Products and Medic...

Speaker(s): Carl Patterson

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will un...

The Rush for ISO13485- 2016
Recorded Webinar
February 24, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

The Rush for ISO13485- 2016

Speaker(s): Yuval Shapiro

In this session Mr. Shapiro will provide an overview of the history of the ISO13485, and the newly introduced changes. The Speaker will also discuss how the changes interact with regulatory requiremen...

Top Process Validation Mistakes - And How to Avoid Them
Recorded Webinar
February 25, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Top Process Validation Mistakes - And How to Avoid...

Speaker(s): Susanne Manz

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...

ANDA Submission and GDUFA Guidance
Recorded Webinar
March 09, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

ANDA Submission and GDUFA Guidance

Speaker(s): Mr.Charles H Paul

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...

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration
Recorded Webinar
March 16, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Creation of DHFs, DMRs, and DHRs utilizing the pri...

Speaker(s): Jose Mora

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries.  Just as ...

Pharmaceutical Water Systems
Recorded Webinar
March 17, 2022 | EST : 03:00 PM | PST : 12:00 PM

Intermediate 60 min

Pharmaceutical Water Systems

Speaker(s): Carl Patterson

This webinar provides an overview on the different types of water systems used in the pharmaceutical industry. Attendees will be provided a comprehensive overview of the different types of water syste...

How Home Healthcare is Changing the Medical Device Game
Recorded Webinar
March 17, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

How Home Healthcare is Changing the Medical Device...

Speaker(s): Tom KraMer

Medical devices will look and feel different in the next 20 years because our design criteria are changing. Home healthcare and the demands of remote patient monitoring add a new level of complexity. ...

Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances
Recorded Webinar
March 22, 2022 | EST : 01:00 PM | PST : 10:00 AM

Advanced 60 min

Root Cause Analysis (RCA) in the Laboratory - Addr...

Speaker(s): Michael Brodsky

This RCA webinar will define a specific set of steps and associated tools that you can use to determine the primary cause of non-conformance in your laboratory. You will learn to determine what happen...

Onboarding New or Transferred Employees in a GMP Environment
Recorded Webinar
March 30, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Onboarding New or Transferred Employees in a GMP E...

Speaker(s): Michael Esposito

The objective of the course is to enable attendees to:Define the onboarding process in the context of regulatory complianceInteract with Human Resources to create a coordinated onboarding strategy tha...

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
Recorded Webinar
April 04, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

HVAC and GMP Environmental Control - for Pharmaceu...

Speaker(s): Roger Cowan

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product.The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of s...

Data Integrity and Governance for Computer Systems Regulated by FDA
Recorded Webinar
April 07, 2022 | EST : 03:00 PM | PST : 12:00 PM

Advanced 60 min

Data Integrity and Governance for Computer Systems...

Speaker(s): Carolyn Troiano

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 da...

Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
Recorded Webinar
April 12, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Pharmaceutical Compressed Air - Quality GMP Requir...

Speaker(s): Roger Cowan

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a ...

Medical Device Cyber-security following latest FDA Guidance
Recorded Webinar
April 20, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Medical Device Cyber-security following latest FDA...

Speaker(s): Edwin Waldbusser

The company must establish a program where they identify, analyze and control cybersecurity risks for both pre market and post market.The cybersecurity program must be carefully planned. A formal spec...

Organizational Change Management for FDA Regulated Computer Systems
Recorded Webinar
April 21, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Organizational Change Management for FDA Regulated...

Speaker(s): Carolyn Troiano

We will discuss the importance of applying industry best practices for organizational change management as they relate to the planning, execution and validation of systems to comply with FDA requireme...

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Recorded Webinar
April 26, 2022 | EST : 01:00 PM | PST : 10:00 AM

Advanced 90 min

21 CFR Part 820 - Quality System Regulation - Appl...

Speaker(s): Jose Mora

Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods and complex filing systems for purposes of retrieval and con...

The Importance of Packaging and Labeling in Pharmaceutical Production – Best Practices
Recorded Webinar
April 27, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

The Importance of Packaging and Labeling in Pharma...

Speaker(s): Michael Esposito

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 distribut...

Quality Risk Management Overview
Recorded Webinar
April 28, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Quality Risk Management Overview

Speaker(s): Steven Laurenz

Recognize the purpose and value of Quality Risk Management (QRM), as well as how it applies to your job.Explain the level of risk based on severity, occurrence, and detectability and how the QRM proce...

Genotoxic Impurities in Drug Development
Recorded Webinar
May 02, 2022 | EST : 03:00 PM | PST : 12:00 PM

Intermediate 60 min

Genotoxic Impurities in Drug Development

Speaker(s): Dr. Stefano Persiani

Residual impurities resulting from the synthetic route, the formulation, or from degradation of the active drug and/or the excipients, may be present in the pharmaceutical products that will be admini...

Process Validation Requirements and Compliance Strategies
Recorded Webinar
May 11, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Process Validation Requirements and Compliance Str...

Speaker(s): Jose Mora

This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, ...

510(k) and PMA Refuse to Accept Policy
Recorded Webinar
May 18, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

510(k) and PMA Refuse to Accept Policy

Speaker(s): Mr.Charles H Paul

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 provid...

Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
Recorded Webinar
May 19, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Sterile Filtration of Pharmaceutical Products - Wh...

Speaker(s): Roger Cowan

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtra...

Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Recorded Webinar
May 19, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Data Integrity and Privacy – compliance with 21 CF...

Speaker(s): David Nettleton

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications.  It explains how to write a Data Pr...

USP 1224- Transferring the Method to meet Regulatory Expectations
Recorded Webinar
May 19, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

USP 1224- Transferring the Method to meet Regulato...

Speaker(s): Carl Patterson

When transferring validated methods between laboratories and sites, their validated states must be maintained to safeguard the exact consistent results in the receiving laboratory. The critical points...

Biomarkers in Drug Discovery and Development
Recorded Webinar
June 07, 2022 | EST : 03:00 PM | PST : 12:00 PM

Intermediate 60 min

Biomarkers in Drug Discovery and Development

Speaker(s): Dr. Stefano Persiani

A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention. The potential benefits of a b...

US Biosimilar Regulations, Barriers and FDA Expectations
Recorded Webinar
June 08, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

US Biosimilar Regulations, Barriers and FDA Expect...

Speaker(s): Peter Wittner

This webinar will discuss the history of biosimilar - how EMA led the way and how FDA is catching up. It will give Insight into the varying regulatory approaches prevailing in different regions & ...

Pharmacovigilance Auditing and Inspections
Recorded Webinar
June 13, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Pharmacovigilance Auditing and Inspections

Speaker(s): Michael Ramcharan

Establishing a Risk based Pharmacovigilance audit program in line with current Regulatory requirements and covering audit types and tools that can be used.An insight into preparing and managing Pharma...

Computer System Validation (CSV) vs Computer Software Assurance (CSA) as an Approach to Meeting FDA Compliance
Recorded Webinar
June 15, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Computer System Validation (CSV) vs Computer Softw...

Speaker(s): Carolyn Troiano

As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and mana...

ISO13485- Quality Management Systems for Medical Devices
Recorded Webinar
June 22, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

ISO13485- Quality Management Systems for Medical D...

Speaker(s): Yuval Shapiro

This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU.Prior to engaging the process of establishing and certifying...

Writing Effective SOPs for the Medical Device and Pharmaceutical Industries
Recorded Webinar
June 23, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Writing Effective SOPs for the Medical Device and ...

Speaker(s): Carl Patterson

This webinar will help you to write clear, concise, and flexible SOPs. You will learn techniques for creating easy to read and clear SOPs your employees can easily follow. Well written SOPs ensure tha...

Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities
Recorded Webinar
June 28, 2022 | EST : 03:00 PM | PST : 12:00 PM

Intermediate 60 min

Complaint Handling Requirements – Interrelationshi...

Speaker(s): Mr.Charles H Paul

This webinar will discuss the regulatory requirements for handling complaints for both medical devices and pharmaceutical products as well as how change control, adverse event reporting and recalls ap...

GMP Environmental Monitoring in Pharmaceutical Clean Rooms
Recorded Webinar
June 28, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

GMP Environmental Monitoring in Pharmaceutical Cle...

Speaker(s): Roger Cowan

This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viab...

Zero Acceptance Sampling Plans to Reduce Inspection Costs
Recorded Webinar
June 29, 2022 | EST : 01:00 PM | PST : 10:00 AM

Basic 60 min

Zero Acceptance Sampling Plans to Reduce Inspectio...

Speaker(s): William Levinson

Overview of ANSI/ASQ Z1.4 including definition of the sample size n and acceptance number c based on (1) the lot size, (2) the acceptable quality level, and (3) the inspection level.Average sample num...

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Recorded Webinar
August 02, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 90 min

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA...

Speaker(s): Carolyn Troiano

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industri...

Training for New Technical Writers
Recorded Webinar
August 05, 2022 | EST : 01:00 PM | PST : 10:00 AM

Intermediate 60 min

Training for New Technical Writers

Speaker(s): Robert Peoples

The objective of the webinar is training to become Technical Writers. Technical Writing is labor-intensive. By that, I mean that someone learns to be a Technical Writer by creating Technical Documents...