Advanced Data Integrity for Pharmaceutical Manufacturing



Published 11/2024
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 2h 8m | Size: 2.73 GB

Achieve Regulatory Compliance with Cutting-Edge Data Integrity Techniques


What you'll learn
1. Understand and Apply ALCOA+ Principles
2. Implement Risk-Based Approaches for Data Integrity
3. Ensure Compliance with Regulatory Standards
4. Utilize Technology and Automation for Enhanced Data Integrity
5. Develop and Manage Data Integrity Systems
6. Investigate and Resolve Data Integrity Issues
7. Improve Audit Readiness and Reporting
8. Foster a Culture of Data Integrity within Organizations
Requirements
No Data Integrity experience needed. You will learn every thing you need to know.
Description
Unlock the Power of Data Integrity and Compliance in Pharmaceutical Manufacturing!Are you ready to master data integrity-the cornerstone of compliance in the pharmaceutical industry? In today's regulated world, ensuring the accuracy, reliability, and security of data is crucial for pharmaceutical companies. This Advanced Data Integrity for Pharmaceutical Manufacturing course is designed to equip you with the essential skills to safeguard data integrity across all stages of the manufacturing process, from production to quality control.Whether you're a pharmaceutical professional, quality manager, or compliance specialist, this course will take your knowledge to the next level by focusing on real-world applications, regulatory frameworks, and industry best practices.What You'll Learn:Master Data Integrity Principles: Learn the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, and Accurate) and how they apply in a pharmaceutical manufacturing setting.Comply with Global Regulations: Understand the critical regulations, including FDA 21 CFR Part 11 and EMA Annex 11, ensuring your organization is audit-ready and fully compliant.Leverage Cutting-Edge Technology: Explore how electronic systems, audit trails, and HPLC instruments contribute to maintaining impeccable data integrity.Risk Management Strategies: Implement risk-based approaches to identify and mitigate potential data integrity breaches, ensuring continuous monitoring and improvement.CAPA for Data Integrity: Develop Corrective and Preventive Actions (CAPA) plans that address data breaches and ensure long-term solutions.Why This Course?Real-World Case Studies: Learn from practical examples of data integrity challenges and solutions in pharmaceutical environments.Interactive Learning: Engage with quizzes, case studies, and downloadable resources to apply your knowledge in real-time.Expert-Led Instruction: Benefit from insights and guidance from an instructor with over 25 years of experience in pharmaceutical compliance, quality management, and regulatory affairs.Career-Enhancing Skills: Data integrity is critical to any pharmaceutical career-this course will help you stand out and bring value to your organization by enhancing your compliance capabilities.Who Should Enroll?This course is perfect forharmaceutical professionals working in production, quality assurance, or data management.Quality Managers aiming to improve data integrity practices within their teams.Compliance Officers looking to sharpen their regulatory knowledge.IT Specialists managing electronic systems in pharmaceutical environments.Don't wait-join this Advanced Data Integrity for Pharmaceutical Manufacturing course today and gain the skills to elevate your expertise and ensure compliance in this critical area of pharmaceutical manufacturing!
Who this course is for
1. Quality Assurance (QA) and Quality Control (QC) Professionals: o Individuals who oversee compliance with Good Manufacturing Practices (GMP) and ensure that all data generated during manufacturing is accurate and reliable. o QA specialists who perform audits and need to understand data integrity for ensuring regulatory compliance.
2. Regulatory Affairs Specialists: o Professionals responsible for submitting documentation to regulatory authorities like the FDA or EMA. o Those who need to ensure that their organization's data management processes comply with data integrity standards in regulatory submissions.
3. Pharmaceutical Manufacturing Managers: o Manufacturing leads responsible for overseeing production processes, ensuring that data related to batch records, equipment logs, and product testing are properly recorded and maintained.
4. IT and Data Management Teams: o Individuals working on the implementation of electronic data management systems in pharmaceutical facilities, ensuring that data systems comply with regulatory standards such as 21 CFR Part 11. o Data integrity officers and system administrators responsible for managing secure data storage, access controls, and traceability.
5. Validation and Compliance Specialists: o Professionals involved in validating computerized systems, ensuring that the data they generate remains consistent and compliant with industry standards. o Individuals responsible for validating processes and ensuring accurate data reporting in validation documentation.
6. Pharmaceutical Consultants: o Consultants who provide advisory services to pharmaceutical companies on best practices for data integrity, regulatory audits, and risk management in manufacturing environments.
7. Pharmacovigilance and Safety Experts: o Those responsible for post-market surveillance and safety reporting, ensuring the integrity of adverse event data and compliance with regulatory bodies.
8. Pharmaceutical Project Managers: o Managers leading projects related to quality improvement and data systems implementation, who need to understand how data integrity affects project outcomes and regulatory compliance.
9. R&D Scientists: o Researchers involved in drug development who need to ensure that research data is recorded and maintained in line with data integrity principles for eventual submission to regulatory bodies.
10. Auditors and Inspectors: • Internal and external auditors tasked with conducting data integrity audits as part of regulatory compliance assessments in pharmaceutical manufacturing.
Homepage:

Advanced Course-Masterclass- SAP ABAP



Published 11/2024
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 47m | Size: 332 MB

Masterclass- SAP ABAP


What you'll learn
Learn SAP ABAP
SAP ABAP Data types
SAP ABAP Variables
SAP ABAP Smartforms
Requirements
Learn everything you need to know
Description
ABAP stands for Advanced Business Application Programming, a 4GL (4th generation) language. Currently it is positioned, along with Java, as the main language for SAP application server programming.Let's start with the high level architecture of SAP system. The 3-tier Client/Server architecture of a typical SAP system is depicted as follows.The Presentation layer consists of any input device that can be used to control SAP system. This could be a web browser, a mobile device and so on. All the central processing takes place in Application server. The Application server is not just one system in itself, but it can be multiple instances of the processing system. The server communicates with the Database layer that is usually kept on a separate server, mainly for performance reasons and also for security. Communication happens between each layer of the system, from the Presentation layer to the Database and then back up the chain.Note − ABAP programs run at the application server level. Technical distribution of software is independent of its physical location. It means basically all three levels can be installed on top of each other on one computer or each level can be installed on a different computer or a server.ABAP programs reside inside the SAP database. They execute under the control of the runtime system that is a part of the SAP kernel. The run-time system processes all ABAP statements, controlling the flow logic and responding to user events.So, unlike C++ and Java, ABAP programs are not stored in separate external files. Inside the database, ABAP code exists in two forms −Source code that can be viewed and edited with the ABAP workbench tools.Generated code, which is a binary representation. If you are familiar with Java, this generated code is somewhat comparable with Java byte code.The run-time system can be considered as a virtual machine, just similar to Java virtual machine. A key component of the ABAP run-time system is the database interface that turns database independent statements (Open SQL) into the statements understood by the underlying database (Native SQL). SAP can work with a wide variety of databases and the same ABAP program can run on all of those.
Who this course is for
SAP ABAP Developers
Homepage:

StartAllBack 3.8.13.5197 Multilingual



File size: 2.0 MB

With Windows 11 officially released, users who want to enjoy the power of the new operating system must get accustomed to the new desktop layout and the enhanced looks. Created by the developers of the popular StartIsBack application, StartAllBack is an enhancement tool specifically designed to bring back the classic layout and looks to a Windows 11 computer.


Restore and improve taskbar
Show labels on task icons
Adjust icon size and margins
Move taskbar to top, left or right edges
Drag and drop stuff onto taskbar
Center task icons but keep Start button on the left
Split into segments, use dynamic translucency
Separate corner icons with Windows 7/10 UI
Restore and improve File Explorer UI
Ribbon and Command Bar revamped with translucent effects
Details pane on bottom
Old search box (the one which works)
Dark mode support for more dialogs
Restore and improve context menus
All new look with rounded acrylic menus
Fast and responsive taskbar menus
New fonts, better touch support
Restore and improve start menu
Launch apps and go to system places in one click
Navigate dropdown menus like a boss
Enjoy fast and reliable search
Finally, lightweight styling and UI consistency
Enjoy Windows 7, Windows 10 and third-party taskbar and start menu styles
Fix UI inconsistencies in Win32 apps
Don't be blue: recolor UI in all windows apps
Negative resource usage: fewer RAM used, fewer processes started

reaConverter Pro 7.834 Multilingual



File size: 309.6 MB

A Better Way to Handle Your Images. Flexible, Smart and Very Fast. Understandable on a hunch, reaConverter makes batch conversion and oft-recurring image editing simple. Every year thousands of users around the world save thousands of hours using reaConverter!


Versatility
As well as handling every conceivable format you may encounter, reaConverter also provides a command line utility allowing you to process images automatically.
Power
And of course, we've added all the most useful features, such as image editing and the most efficient batch processing in any software of this type.
Add Images
Load files you want to process.
Apply Editing
Select from a variety of editing actions.
Save the Result
Choose output format and folder, tune saving options.
Automate
All the actions are available in an automatized way.
Widest Range of Supported Formats
- Highly efficient software that makes it easy to convert millions of files and folders in a single operation.
- Convert between a great number of file formats, including archaic and rare ones.
Ample Scope for Image Editing
- Understandable on a hunch, reaConverter makes oft-recurring image editing simple.
- Touch up, transform, apply editing and effects to any number of images at the same time.
Version 7 puts the functionality to the whole new level
Ultra-fast multi-threaded conversion
entirely reworked user interface
image editing options and graphic filters
formats support including CAD and MS Office documents
ways to save the conversion result
Watch Folders feature to monitor folders and automatically apply processing
command-line tool for simple integration to server-side and third-party solutions
Whats New
Updates: official site does not provide any info about changes in this version.
Homepage:

Plug And Mix VIP Bundle v4.0.0



File Size: 160.8 MB

The V.I.P. Bundle is a complete set of 50 streamlined audio plugins, each designed to perform a single, specific task with precision and ease. Ideal for musicians, producers, and sound engineers alike, this bundle covers a wide range of essential effects and audio treatments, making it effortless to achieve professional results in record time.


Each V.I.P. plugin is built to be quick and intuitive: load it up, explore the presets, adjust just a few controls, and move on to the next track. Need a classic phaser on a guitar? Just load the P&M Phaser, tweak a couple of knobs, and get the perfect tone in seconds. With everything from EQs and compressors to reverbs, delays, and creative modulation effects, the V.I.P. Bundle is the Swiss knife of audio plugins-ready to handle whatever your mix demands.
Version 4 of the V.I.P. Bundle brings enhanced DSP for lower CPU usage, updated interfaces with resizable GUIs, and full compatibility with the latest OS and DAW platforms. Download the V.I.P. Bundle v4 today to discover how streamlined, high-quality plugins can elevate your workflow and your sound.
What's New
official site does not provide any info about changes in this version.
Homepage:

Pitch Innovations Eternal Arps v1.0.0



File size: 346.4 MB

Say goodbye to robotic, repetitive arpeggios - Inspired by real performances, Eternal Arps is a next-gen arpeggiator instrument that produces human-like arpeggios by transforming your MIDI input into musical patterns, breaking free from the robotic limitations of traditional arpeggiators


Whats New
Updates: official site does not provide any info about changes in this version
Homepage:

Pazu StreamGet All-In-One Video Downloader 2.4.0 Multilingual



File size: 208.1 MB

Download movies and shows from various streaming platforms to MP4/MKV on your Windows device and enjoy them anywhere you want.


Download videos from the most popular streaming services including Netflix, Prime Video, Disney Plus, Max, Hulu, Apple TV Plus, and more.
Download movies and shows to MP4/MKV
High-quality downloads up to 1080p.
Freely choose to keep any or all audio and subtitles.
8x fast downloading speed
Multiple downloads at a time
Select how subtitles are saved (hardcoded, softcoded, or external files).
Multilingual interface: English, Deutsch, Espanol, Francais.
Download All, Download Now
StreamGet All-In-One Video Downloader is the ultimate download solution for you. It supports downloading any movies and shows from the most popular streaming websites including Netflix, Prime Video, Disney Plus, Max, Hulu, and Apple TV Plus. The downloader is continuously updated to support more platforms in the future.
Support downloading from various streaming platforms
Download as many movies and shows as you want
Watch on any supported device
Download movies in up to 1080P
Continuously updated
User-friendly Interface and built-in browser
StreamGet All-In-One Video Downloader simplifies your download process by offering a built-in browser. This allows you to directly search for movies or TV shows within the application. Simply select your preferred streaming service from the homepage, enter a title or keywords, and let StreamGet present the search results for you.
One-stop browsing experience with the built-in browser
Simple and clear user interface
Multilingual Support
Search the movie/show title or copy&paste the link
Download videos in high quality at a fast speed
StreamGet All-In-One Video Downloader delivers the perfect combination of speed and quality. You can download high-quality videos starting from 720p(HD) and up to 1080p (FHD). Moreover, it uses multi-threading to increase download speed. Experience downloads 8x faster than standard speeds.
8x fast downloading speed
One click to download all seasons and epidodes
Choose the format, audio track, and subtitle you want
Download videos in H.265(High-Efficiency Video Coding, HEVC) or H.264(Advanced Video Coding, AVC).
Audio and subtitle customization
StreamGet All-In-One Video Downloader offers comprehensive multi-language support for downloaded videos. You can choose to download audio tracks and subtitles in any language available on the original streaming service. This flexibility ensures you can enjoy your content in your preferred language.
Freely choose to keep any audio and subtitles available.
Save subtitles as Soft subtitles, External subtitles or Hard subtitles.
Support preserving all available audio track and subtitle languages.
Keep Audio description and Audio surround sound
Ultimate offline playback experiences
With StreamGet All-In-One Video Downloader, you can download videos from Netflix, Amazon Prime Video, Disney+, Max, Hulu, and Apple TV+ even with an ad-supported subscription. These downloaded videos can be transferred to various compatible devices and applications for offline playback, offering greater flexibility in how you enjoy your favorite content.
Download videos even with an ad-supported account
Watch streaming videos offline on any devices you want
No video streaming app is required
Downloaded videos are stored locally and will never expire.

Nuro Audio Xvox Pro 1.0.5



File size: 85.4 MB

Xvox Pro comes with 6 plugins to supercharge your workflow - including Xvox Pro, Xvox Comp, Xvox DS, Xvox Tone, Xvox Space, and Xvox SFX.


The most powerful vocal mixing suite ever built. Packed into a revolutionary interface to get you pro results with total flexibility - faster and easier than ever before.
Whats New
Updates: official site does not provide any info about changes in this version
Homepage:

Nuro Audio Xrack Pro 1.0.2



File size: 98.6 MB

Xrack Pro Mix Smarter, Not Harder. Analog-modeled mixes at your fingertips. Meet the ultimate mix rack.


A Full Suite of Powerful New Processors. Xrack Pro comes with 7 plugins to supercharge your workflow - including Xrack Pro, Xrack Sat, Xrack Comp, Xrack Transient, Xrack Tone, Xrack Mod, and Xrack Max. Xrack Pro features a curated selection of pro presets - organized by instrument so you'll always find a perfect starting point. Whether you want to warm up a track, add more excitement and color, or add massive punch and impact - there's always a perfect preset to get started. Jump to the perfect starting point with just a click, then dial it in with the intuitive controls.
Xrack Comp
Xrack Max
Xrack Mod
Xrack Pro
Xrack Sat
Xrack Tone
Xrack Transient
Whats New
Updates: official site does not provide any info about changes in this version
Homepage:

n-Track Studio Suite 10.2.0.9147 Multilingual



Windows x86/x64 | File size: 386.76 MB

n-Track Studio turns your PC into an easy to use multitrack audio recording studio. It is the perfect tool for professional quality audio recording, encoding, mixing and editing. Record, edit, overdub your audio tracks, apply effects, process audio live input, mix and then burn audio CDs or create mp3 files. n-Track Studio is an Audio and MIDI Digital Multitrack Recorder that transforms your computer into a powerful audio recording studio. You can record, playback, overdub your audio tracks exploiting the flexibility and power of today's PCs for applying effects, realtime input processing, automated aux channels sends and returns, destructive and non-destructive wave editing. The program supports 24bit-192 khz recording, 64 bit mixing, multiple channels soundcards, live input processing, CD burning, mp3 encoding and more.


Main n-Track Studio features
• Records and plays back a virtually unlimited number of audio and MIDI tracks
• DirectX, VST and ReWire effects can be added to each channel/track
• Built-in effects include Reverb, Compression, Parametric and Graphic EQ, Echo, Auto-volume, Pitch Shift, Chorus, Multiband Compression, Spectrum analyzer
• Supports 16 and 24 bit single and multichannel soundcards at sampling frequencies up to 192 Khz using Asio, WaveRT, WDM, MME and DirectSound
• Is compatible with multichannel Asio, WaveRT, WDM and MME audio drivers, which means that n-Track can work with almost any soundcard available today with the lowest possible latency
• Supports VST Instruments and DirectX Instruments synth plug-ins. Sample-accurate MIDI tracks can be sent to VSTi/DXi software MIDI synths, without the need of expensive hardware MIDI synths.
• Adjust the effect settings and listen to the result in real time.
• Built-in effects include Reverb, Compression, Parametric and Graphic EQ, Echo, Auto-volume, Pitch Shift, Chorus, Multiband Compression, Spectrum analyzer.
• Supports third party DirectX, VST 2.0 and ReWire plug-ins.
• Realtime Audio effects can be added to each channel.
• Supports 16 and 24 bit single and multichannel soundcards at sampling frequencies up to 192 Khz using Asio, WaveRT, WDM, MME and DirectSound.
• Input processing allows to process with plug-ins live signals. Record the 'dry' (unprocessed) signal while processing and reprocess the recording later - i.e. Play a guitar through a distortion plug-in then change the distortion after the recording!
More Features
• Supports surround mixing for creating DVD audio projects using 5.1, 6.1 and 7.1 channels surround formats
• Each audio track includes a 20 bands parametric EQ with graphical frequency response view, a full spectrum analyzer and an automatic instrument tuner. Up to 32 aux channels with fully automated sends and returns.
• Supports multiple input and output soundcards or more than one soundcard. You can record multiple tracks at a time and output to more than one stereo output. Each output channels has its own master channel effects and volume control.
• Supports technology by Propellerhead Software AB. Mix signals in realtime with n-Track's own channels from other programs (such as Reason, Ableton Live, Fruityloops and many others).
• Import and export .wav, .mp3, .wma, .mid, .ogg, .flac, .aiff, .cda, .sng, .sgw audio files
• Import and export EDL multitrack song files for exchanging songs with other multitrack programs
• Sync to other programs or external devices using SMPTE/MTC or MIDI Clock sync, acting either as master or slave
• Loads and saves MIDI tracks to standard MIDI files
• Play Videos (AVI, MPEG) in sync with the song in a dedicated video playback window
• Automated volume, pan, aux sends and returns and effects parameters. You can "program" fade-in/outs, cross fades, boost the volume of a track when there is a solo etc.