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2-Day Virtual Seminar on Supplier and Contract Manufacturer Management
This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification of a supplier and continuing through building a relationship, risk management, ongoing assessment (including auditing) and finally planning for an exit. The course will show attendees how to use risk assessment for ranking suppliers and […] -
Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software […] -
Power Analysis for Sample Size Calculations
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. Some code and demonstrations will be provided for powering studies and performing power analysis simulations in R software. Questions related to the […] -
Key Elements of HPLC and UPLC Method Validation to Ensure Compliance with FDA and ISO Requirements
Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, […] -
GMPs for Medical Marijuana Production Operations Cannabis GMP
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 yet legalized medical cannabis (though this situation might soon change). As a result, the industry lacks a common framework/standard for food […] -
2-Day Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform, and are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing. Pharmaceutical employees often do not realize that by putting their processes in writing, they are making commitments […] -
2-Day Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA
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 other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, […] -
3-Day Annual GMP Master Class for 2022 – Virtual Seminar
cGMPs or Current Good Manufacturing Practices is a general encompassing term for the regulations that the control of all facets of life sciences manufacturing processes and facilities particularly pharmaceutical products. It is crucial, for any entity to be compliant, that every individual within the organization fully understand and adhere to these regulations in the course […] -
Latest Trends in Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior […] -
Cybersecurity – FDA Requirements Masterclass
Cybersecurity is the art of protecting networks, devices, and data from unauthorised access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information. Cybersecurity is the preventing the theft / modification of e-records by unauthorised access. A growing concern for all – legal, financial, consumer, personal, and the FDA. t’s […]
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Recording 3-Day Annual GMP Master Class for 2022 – Virtual Seminar
cGMPs or Current Good Manufacturing Practices is a general encompassing term for the regulations that the control of all facets of life sciences manufacturing processes and facilities particularly pharmaceutical products. It is crucial, for any entity to be compliant,... -
Recording
Aseptic Processing and Techniques 101
Many of the drug products manufactured for use are injected into our bodies. By avoiding our first line of defense against infection, any possible source of infection can wreak havoc on our immune systems. In order in insure our... -
Recording
Project Management Utilizing Principles of Lean Documents and Lean Configuration
Project Management involves not only the management of tasks and task owners, but also of information involving documents, records, and many other elements. The traditional approach is to compile, create and push these through the various stages. The concept... -
Recording
Latest Trends in Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start... -
Recording
2-Day Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform, and are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing. Pharmaceutical... -
Recording
2-Day Virtual Seminar on Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA
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 other FDA-regulated industries. The... -
Recording
Is My Data Abnormal? Normality Tests and Transformations
This webinar will show you how to check for normality in your data and apply transformations to non-normal data. Many of the commonly used statistical tests and calculations of chart limits (or other measurements) require that the data be... -
Recording
3-Hour Virtual Seminar on Computer System Validation (CSV) vs Computer Software Assurance (CSA) – Following a Waterfall vs Agile Methodology
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance... -
Recording
2-Day Virtual Seminar on Supplier and Contract Manufacturer Management
This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification of a supplier and continuing through building a relationship, risk management, ongoing assessment (including auditing) and finally planning for... -
Recording
2-Day Virtual Seminar on FDA Inspection Essentials in 2022
Upon completion of this session, you will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the...
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Recording
3-Hour Virtual Seminar on Computer System Validation (CSV) vs Computer Software Assurance (CSA) – Following a Waterfall vs Agile Methodology
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance... -
Recording
6-Hour Virtual Seminar on QbD and Technology Transfer Program – A Practical Approach to Successful Implementation
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. Quality needs to be built in to the product at design stage. So, we... -
Recording
6-Hour Virtual Seminar on Annual Product Quality Reviews – Preparation, Reports, Impact of Latest Quality Metrics Guidance
Product Quality Review and Annual Product Review are the favorite documents for the inspectors and QPs. This pandemic is impacted on auditing also. Many regulatory agencies are planning audits based on risk-based approach. The Annual Product Quality Review (APQR)... -
Recording
6-Hour Virtual Seminar on Statistics for Quality Control
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical quality control: obtaining information... -
Recording
2-Hour Comprehensive Seminar on Measurement Systems Analysis
Attendees will also receive an Excel spreadsheet with the d*2 factors that are required for the average and range method, and another with data for the worked examples. These appear in some references that are named in the handout,... -
Recording
6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries
Pharmaceutical and Biotech laboratories use a multiple array of various gadgets, devices, analytical instruments and computerized systems on a daily basis. Qualification of equipment or ancillary systems are necessary to prove that all critical requirements work as intended and... -
Recording
3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019
Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while... -
Recording
3-Hour Virtual Seminar on Statistical Process Control (SPC), Process Capability, and Non-Normal Distributions
This 3-session seminar will cover: Process capability and process performance, which reflect the ability of a process to meet specifications. A Six Sigma process will, when centered on the nominal, have only two nonconformances or defects per billion opportunities.... -
Recording
3-Hour Virtual Seminar on Design Controls for Medical Devices
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.... -
Recording
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
Project Management is defined as the planning and organization of an organization’s resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are...
