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Why Kymanox Our training is up-to-date, real-world, and offered in a variety of convenient formats. We compile the latest regulatory statutes and guidance from industry bodies with actionable items to help your team satisfy requirements and meet expectations. Our trainers are life science professionals, not 100% dedicated trainers, coming straight from the plant floor and audit war room to you. We have access to the latest tools and techniques being used in the industry - which you can bring straight to your team. You receive the same training content provided internally to our team. Sample Training Topics • Deviations, Corrective and Preventative Actions (CAPAs), and Investigations • Change Control • Quality Auditing and Supplier Quality Management • Pre-Approval Inspection (PAI) Readiness • CGMP, Good Documentation Practices, and Data Integrity • Analytical Method Development and Validation • Process Validation and Process Surveillance • Computer Systems Validation and Part 11 Compliance • Tech Transfer, Scale-up, and Commercialization • Quality Engineering for Combination Products and Devices • FDA, EMA, and other Regulatory Body Compliance • Project Management • Risk Management, Plans, and Assessments • CGxP Statistics and Technical Writing • Quality Management Systems for Biopharma, Devices, and IVDs +1 919-246-4896 | www.GxPBAR.com | [email protected] Be More Informed. Get More Done. KYMANOX TRAINING Biotechnology | Pharmaceuticals | Medical Devices | Combination Products Public Webinar Private DIY Hot button training topics delivered to groups of 10 to 100 people. Engage with our team of experts and network with fellow professionals. Certification documentation can be provided for annual compliance training. Our team of subject matter experts deliver trainings and case studies straight from the real world. Attend live or download recording upon completion from www.KymanoxWORKS.com to view at your convenience. Training brought straight to your company with tailored ½- day, full-day, or two-day sessions curated to match your exact needs. Customized workshops hosted at your site or our facilities. Can’t make a training session or need help ASAP? View and download our state- of-the-art training documents, SOPS, and toolkits at www.KymanoxWORKS.com. From slide decks to quizzes to real-world examples, we cover the most important topics facing the industry.
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Biotechnology | Pharmaceuticals | Medical Devices ...€¦ · Our training is up-to-date, real-world, and offered in a variety of convenient formats. We compile the latest regulatory

Sep 25, 2020

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Page 1: Biotechnology | Pharmaceuticals | Medical Devices ...€¦ · Our training is up-to-date, real-world, and offered in a variety of convenient formats. We compile the latest regulatory

Why KymanoxOur training is up-to-date, real-world, and offered in a variety of convenient formats. We compile the latest regulatory statutes and guidance from industry bodies with actionable items to help your team satisfy requirements and meet expectations.

Our trainers are life science professionals, not 100% dedicated trainers, coming straight from the plant floor and audit war room to you.

We have access to the latest tools and techniques being used in the industry - which you can bring straight to your team. You receive the same training content provided internally to our team.

Sample Training Topics• Deviations, Corrective and Preventative Actions (CAPAs), and

Investigations

• Change Control

• Quality Auditing and Supplier Quality Management

• Pre-Approval Inspection (PAI) Readiness

• CGMP, Good Documentation Practices, and Data Integrity

• Analytical Method Development and Validation

• Process Validation and Process Surveillance

• Computer Systems Validation and Part 11 Compliance

• Tech Transfer, Scale-up, and Commercialization

• Quality Engineering for Combination Products and Devices

• FDA, EMA, and other Regulatory Body Compliance

• Project Management

• Risk Management, Plans, and Assessments

• CGxP Statistics and Technical Writing

• Quality Management Systems for Biopharma, Devices, and IVDs

+1 919-246-4896 | www.GxPBAR.com | [email protected]

Be More Informed.Get More Done.

KYMANOX TRAINING

Biotechnology | Pharmaceuticals | Medical Devices | Combination Products

Public Webinar Private DIYHot button training topics delivered to groups of 10 to 100 people.

Engage with our team of experts and network with fellow professionals.

Certification documentation can be provided for annual compliance training.

Our team of subject matter experts deliver trainings and case studies straight from the real world.

Attend live or download recording upon completion from www.KymanoxWORKS.com to view at your convenience.

Training brought straight to your company with tailored ½- day, full-day, or two-day sessions curated to match your exact needs.

Customized workshops hosted at your site or our facilities.

Can’t make a training session or need help ASAP? View and download our state-of-the-art training documents, SOPS, and toolkits at www.KymanoxWORKS.com.

From slide decks to quizzes to real-world examples, we cover the most important topics facing the industry.

Page 2: Biotechnology | Pharmaceuticals | Medical Devices ...€¦ · Our training is up-to-date, real-world, and offered in a variety of convenient formats. We compile the latest regulatory

Kymanox is Your Life Science Solutions Partner for TrainingThroughout the growth of Kymanox, Ideal Knowledge Transfer™ (IKT) has remained at the core of our focus. Knowledge transfer is akin to teaching and learning with a predetermined goal in mind. When information, expertise, or technology moves from one place to another, knowledge transfer is taking place. Not only do we seek to transfer knowledge to our clients and employees, but we also seek ways to pass on information via other methods to the life science communities.

The Kymanox Knowledge Bar™ is a way for our organization to pass to your team the experience and knowledge we’ve gained over the years. We employ either public or private training sessions, depending on your company or department need, in order to implement our tenet of Ideal Knowledge Transfer™ (IKT).

KYMANOX KNOWLEDGE BAROur training is up-to-date, real-world, and offered in a variety of convenient formats. We compile the latest regulatory statutes and guidance from industry bodies with actionable items to help your team satisfy requirements and meet expectations. Our trainers are life science professionals, not 100% dedicated trainers, coming straight from the plant floor and audit war room to you.

Be More Informed.Get More Done.