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483 Covers a Broad Gradation of Problems

Ref: 25883 Wednesday October 25th, 2017 - Online

Overview: How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it is well organized, succinct and provides ...

Education: Pharmacy, Medicine, Bio-Technologies, Management

NIST Cybersecurity Framework For Computer Systems Validation

Ref: 25884 Wednesday October 25th, 2017 - Online

Overview:   Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information.  ...

Education: Pharmacy, Medicine, Bio-Technologies, Management

Guidance on Software and Device Changes and the 510(k)

Ref: 25885 Monday October 30th, 2017 - Online

Overview:   The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.   Why should you Attend: Anyone who is involved in software and device design, ...

Education: Pharmacy, Medicine, Bio-Technologies, Management

Quality by Design (QbD) for Pharmaceutical Process R&D

Ref: 26068 10/31/2017 -> 11/02/2017 - Boston US

This Quality by Design (QbD) Course, aimed at organic process chemists & chemical engineers working in the pharmaceutical & related industries, provides a practical approach to QbD implementation.
QbD is no longer a regulatory initiative; because QbD is good development, QbD is an ...

Education: Medicine

New Cosmetic Product Regulation in World Economies 2017

Ref: 26027 Wednesday November 01st, 2017 - Online

Overview: The EU's new Cosmetic Product Regulation (EU CPR) will be given a certain,  wider position as the EU CPR is representing the latest, most modern  regulatory framework which is influencing other global legislators.   Areas Covered in the Session: Basis ...

Education: Pharmacy, Public Health

Première approche de l'hypnose

Ref: 25091 11/02/2017 -> 11/03/2017 - Paris FR

Première approche de l'hypnose :  Ce week-end s’adresse à tous les praticiens qui souhaitent découvrir l’hypnose et ses applications. Il leur permettra de déterminer l’intérêt de cette approche thérapeutique dans leur pratique professionnelle. Programme : - L’hypnose contemporaine et ...

Education: Paramedic, Medicine, Dentistry

Complete 1099, TIN Matching, B-Notice, FATCA 2017

Ref: 26004 11/02/2017 -> 11/03/2017 - Baltimore, MD US

Complete 1099, TIN Matching, B-Notice, FATCA 2017

Education: Medicine, Pharmacy

Onsite GCP Review and Update including the all-important 'Investigators Responsibility' 2017

Ref: 26005 11/02/2017 -> 11/03/2017 - Baltimore, MD US

Onsite GCP Review and Update including the all-important 'Investigators Responsibility' 2017

Education: Medicine, Pharmacy

Medical Device Software: An Incremental Approach to Risk and Quality Management 2017

Ref: 26006 11/02/2017 -> 11/03/2017 - Baltimore, MD US

Medical Device Software: An Incremental Approach to Risk and Quality Management 2017

Education: Medicine, Pharmacy

Principles of Food Extrusion Processing

Ref: 26028 Thursday November 02nd, 2017 - Online

Overview:   This webinar will cover fundamental extrusion processing hardware as well as how that hardware is operated in order to produce the desired product. Both single and twin screw extruders and their differences in operating characteristics will be covered.   Why ...

Education: Pharmacy, Public Health

Requirements for Compliance Compounding Pharmacies

Ref: 26029 Thursday November 02nd, 2017 - Online

Overview: The course will be delivered in two modules. The first module will cover federal and state regulatory agencies governing compounding pharmacies and handling of hazardous drugs for sterile and nonsterile compounding according to USP 800.    Why should you ...

Education: Pharmacy, Public Health

Virtual Seminar on Analytical Method Validation Process

Ref: 26030 Friday November 03rd, 2017 - Online

Overview:   Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.   Why should you Attend:  Method validation is the ...

Education: Pharmacy, Public Health

Calculating, and Using Statistical Power 2017

Ref: 26031 Monday November 06th, 2017 - Online

Overview: This webinar explains the basics, by using a t-test as an example. One of the very many possible formulas is then demonstrated, as well as 2 different software programs and their "Power Curves".    Why should you Attend: Whenever a test of statistical significance is ...

Education: Management, Public Health, Pharmacy

7 Megatrends that Will Transform the Global Marketplace

Ref: 26032 Tuesday November 07th, 2017 - Online

Overview:   The trends will impact virtually every industry that is dependent on supply chains. There is a convergence of supply chain trends that will dramatically change the global marketplace.   Why should you Attend: Understanding of the supply chain trends that will ...

Education: Medicine, Management, Public Health, Pharmacy

Medical Device Hazard Analysis Following ISO 14971 - 2017

Ref: 26033 Wednesday November 08th, 2017 - Online

Overview:   The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.   Why should you Attend:  FDA expects that as part of ...

Education: Pharmacy, Medicine, Management, Public Health

GMP and Regulatory Expectations for Early IND Products 2017

Ref: 26007 11/09/2017 -> 11/10/2017 - Seoul, South Korea US

GMP and Regulatory Expectations for Early IND Products 2017

Education: Medicine, Pharmacy

Agile Meets Software Standards, and We all Win

Ref: 26034 Tuesday November 14th, 2017 - Online

Overview: Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators.   Why should you Attend:  Perhaps you're a development manager, hoping to improve both productivity and ...

Education: Pharmacy, Medicine, Public Health, Management

Latest Regulations for Tobacco Industry Effective 8-2016

Ref: 26035 Tuesday November 14th, 2017 - Online

Overview: The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.   Why should you Attend: How to Build a Compliance Strategy Minimizing Cost while ...

Education: Medicine, Pharmacy, Management

Design of Experiments and Statistical Process Control for Process Development and Validation 2017

Ref: 26010 11/16/2017 -> 11/17/2017 - Kuala Lumpur, Malaysia US

Design of Experiments and Statistical Process Control for Process Development and Validation 2017

Education: Medicine, Pharmacy

HIPAA Compliance for Small Healthcare Providers 2017

Ref: 26011 11/16/2017 -> 11/17/2017 - Boston, MA US

HIPAA Compliance for Small Healthcare Providers 2017

Education: Medicine, Pharmacy

It is not enough to Simply be a Project Manager

Ref: 26036 Thursday November 16th, 2017 - Online

Overview:   We manage tasks and activities, and those activities must be performed by people, who must be led. It is not enough to simply be a Project Manager.    Why should you Attend:  On average it takes ten successful projects to make up for one really bad ...

Education: Pharmacy, Medicine, Management, Public Health

How to Recover Time Lost Due to Performance Issues

Ref: 26037 Thursday November 30th, 2017 - Online

Overview:   It is just a fact of life that someone on your team, whether you selected them or whether they were assigned to you will be a non-performer.   Why should you Attend: Are you spending too much of your own time trying to recover for the poor performance of team ...

Education: Medicine, Pharmacy, Public Health

Hysterectomy Surgery

Ref: 22922 11/16/2015 -> 11/14/2017 - Online

Enjoy less cost hysterectomy surgery benefits in India

Education: Hospital, Surgery, Public Health

Liver Transplant

Ref: 23192 01/25/2016 -> 01/11/2018 - Online

Advanced Liver Transplant in India

Education: Hospital, Surgery

Rotator-Cuff Repair Surgery

Ref: 23331 02/16/2016 -> 02/07/2018 - Online

Affordable Rotator-Cuff Repair Surgery in India

Education: Orthopedic Surgery, Orthopedics, Pediatric Surgery, Pediatrics, Cardiology, General medicine

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