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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to […] -
3-Hour Virtual Seminar on Successful Deviation Investigations
This seminar will help attendees with the fundamentals and best practices for investigating deviations. It will focus on using facts and objective evidence to arrive at root cause and CAPA. To accomplish successful deviation investigations this course will focus on how to avoid the drawbacks that may occur during FDA inspections. We will also discuss […] -
4-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer. A serious threat, it must be […] -
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 requirements vs. adopting best quality practices. There has also been a lower than anticipated investment in […] -
3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
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 computer system validation program and plans for individual systems that have this capability. […] -
CE Marking in the EU – Latest Regulations
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). CE marking is required for many products. CE marks: Show that the manufacturer has checked that their products meet EU safety, health or environmental requirements Are an indicator of a product’s compliance with EU legislation […] -
Expediting Approval for Regenerative Drugs and Breakthrough Therapy Designation
FDA provides 4 programs for accelerated drug approval, each with a specific set of requirements and considerations. Drugs must be for serious conditions that fill an unmet medical need and can be approved based on a surrogate endpoint, or biomarker A drug qualifies for BTD review if it is intended to treat a serious condition, […] -
Secrets to Writing Effective SOPs for Medical Device QMS
Almost every paragraph of the Quality System Regulation says that manufacturers shall “establish” procedures.This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective.You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow.Well written SOPs ensure result in more […] -
Risk-based Design Control – The New Paradigm for Medical Device Design
Risk management is a process that involves the identification of the many considerations, responsibilities, personnel, and the transfer of knowledge. Medical device risk management helps gauge the possible hazards under both normal and fault conditions. It is understood that risk management transcends projects and even companies, thus it is crucial that critical information survive these […] -
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 […]
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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
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 2021
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... -
Recording
Post-Market Surveillance Activities (FDA and EU-MDR) – A Detailed Analysis
Post Market Activities are a GMP regulatory requirement for the medical device industry in both the US and European Union. These activities provide a valuable system for obtaining data and continuous feedback about a medical device that is on... -
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
Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures... -
Recording
Calculations for Process and Product Capability
Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees... -
Recording
Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation
Attendees of this webinar will learn statistically valid methods for using small sample sizes and for using lots as few as 3 when validating processes or products. The focus of this webinar is on providing the information needed for...
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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...
