Manufacturing (GMP) - Life Science Training Institute

How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer

Kathleen Warner

0 Available
seats

This course provides an introduction to FDA’s new guidance on computer software assurance (CSA). This guidance is planned for release in February 2021. In preparation for its release, the course will discuss the who, why and what you will need to know to transition from traditional computer system validation (CSV) to CSA.

Effective Writing for Investigation Authors and Reviewers

Monica Guzman

0 Available
seats

If you are working in a regulated life sciences environment and required to write, edit, or review your organizations’ investigation reports, this is the webinar for you. Learn strategies for improved efficiency and effectiveness in your writing process, helping you to write reports that are more readable, easier to follow, and in line with auditor expectations.

$179.00

Pharmaceutical Sampling Plans – Understanding for Compliance

Mark Allen Durivage

0 Available
seats

The use of acceptance sampling is common in the life science industries. Understanding sampling plans and their linkage to risk is a key to compliance. This course will provide you with how to maximize the effectiveness of your sampling plans to mitigate risk and ensure compliance.

$179.00

Remote Auditing for GMP Compliance During COVID-19: Challenges and Opportunities

Mark Allen Durivage

0 Available
seats

Good Manufacturing Practice (GMP) audits can be difficult under normal circumstances, but especially under mandated quarantine periods like the current COVID-19 crisis. Remote audits allow an organization a viable alternative to ensure continued compliance with GMP by leveraging modern technologies and best practices. This course will show you how to stay compliant while fulfilling audit responsibilities remotely.

Drug Substance Quality Risk Management: A Practical Approach to Identify Critical Quality Attributes and Critical Process Parameters

Kevin Wall

0 Available
seats

The course presents a practical approach to identify critical variability in the drug substance product and process. The process begins with identifying the Critical Quality Attributes of the API and ends with defining critical process parameters. The output is the basis of the CMC control strategy.

Essentials of Disinfectant Efficacy Testing: Ensuring Microbial Control

Crystal Booth

0 Available
seats

Disinfectant efficacy testing is utilized to measure the effectiveness of chemicals that are used clean, sanitize, or disinfect surfaces. Understanding the importance of testing and proper use of disinfectants is essential in avoiding regulatory findings. This webinar will review the essentials of disinfectant efficacy testing.

Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance

0 Available
seats

Change control is a critical piece of any life sciences activity…and a global regulatory requirement. Change control deficiencies are mentioned directly or indirectly in most inspection observation findings. Compliance is a must, and a business imperative. This course will help you get on the right track with your change control programs, documentation, and overall compliance.

Blockchain Technology for the Life Sciences: A Comprehensive Primer

Brooke L. Casselberry

0 Available
seats

This course will explore areas within the life sciences where early adoption is a possibility. A vendor-neutral review of current Blockchain software platforms and their potential fit within your organization will be provided. Finally, you will receive instruction on how to identify and execute the steps necessary for determining if Blockchain is applicable to your function within your organization.

How FDA and MHRA Decide Which Drug Facilities to Inspect – and at What Frequency

(1)

Jerry Chapman

0 Available
seats

This course will be of benefit to anyone working in a GMP regulated environment on global or domestic scale that manages the inspection process, or has input into CMO selection. This includes personnel in:

Quality
Manufacturing
Engineering

Other functions that may be subject to FDA and MHRA audits

Aseptic Process Validation: Top-Tips for Compliance and Success

0 Available
seats

If you manufacture sterile therapeutic products, then you know how critical Aseptic Process Validation is to ensuring compliance with mandates and guidance on a global scale. More importantly, you are aware of the impact on patient safety. This interactive session will cover what you need to know, and the best way to go about doing it. Lessons learned “from the trenches” and best practices gleaned from experience will be shared. Additionally, bonus handouts will be offered so you can immediately implement what you have learned.

A Holistic Approach to External GMP Surveillance, GMP Training, and Quality Knowledge Management

Jerry Chapman

0 Available
seats

This GMP webinar will cover the design and implementation of a GMP surveillance program to ensure awareness of and compliance with ever-changing US and international GMP manufacturing regulations, guidance, inspection findings, trends, and related information, and how the process can be used to create GMP training and made even more valuable across the organization in the context of a quality knowledge management platform.

Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines

Greg Martin

0 Available
seats

A new, dramatically different requirement for elemental impurities is now required for most pharmaceutical products. These mandates cover more metals, but require lower limits than the antiquated “Heavy Metals test.” However, the analytical technique – ICP-MS – is much more challenging.

Writing Effective 483 and Warning Letter Responses

0 Available
seats

The outcome of regulatory inspections is critical to an organization’s success. Though you do your best to avoid it, receiving a FDA Form 483 observation – or even a Warning Letter – is always a possibility. How you respond to warning letters and observations is a challenge and can make or break your ability to avoid further sanctions. What should you include? What are the risks of not submitting an appropriate response? This 90-minute course will discuss 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 elements of a thorough response.

Establishing Appropriate Quality Metrics

0 Available
seats

In 2016, the FDA released a revised draft guidance, “Submission of Quality Metrics Data Guidance for Industry”, describing its Quality Metrics Reporting Program for drugs and biologics. New compliance and inspection policies could be developed as a result of submitted quality metrics. Establishing quality metrics now will help your company prepare for any future regulations as well as drive your Quality Culture toward continuous improvement.

FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS

Joy McElroy

0 Available
seats

Having a robust Quality Management System (QMS) is a critical part of successful pharmaceutical manufacturing operations…and a global regulatory requirement. Having audit-tested and ready Quality Assurance (QA) and Quality Control (QC) teams in place with defined roles within a QMS is the foundation for compliance, but getting there can be tough. This session will show you how.

Executing Proper Event Investigations: Critical Steps In Ensuring Compliant Corrective Actions

Judy Carmody, Ph.D.