Specific Detailed Changes to the New ISO 13485:2016Greenlight Guru
Today's medical device regulatory environment is changing faster than ever. Keeping up can be daunting. The new quality management standard ISO 13485:2016 was published in Q1 of 2016.
greenlight.guru has partnered with special guest and consultant, Mark Swanson, to keep you ahead of these changes.
Mark spent the last 4 years on the working group that revised the new ISO 13485.
Mark has all the exclusive insider knowledge on the changes you want. And he's going to be sharing it with you for free.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-changes)
In this webinar you'll learn specifically:
-How to prepare for the coming regulatory changes with ISO 13485:2016
-How to apply risk based thinking to your quality processes to ensure compliance
-What you need to know about the design control updates
-How to incorporate ISO 9001:2015 and 13485:2016 to your supplier controls
-A general overview of the standard and its most significant changes (before anyone else)
Specific Detailed Changes to the New ISO 13485:2016Greenlight Guru
Today's medical device regulatory environment is changing faster than ever. Keeping up can be daunting. The new quality management standard ISO 13485:2016 was published in Q1 of 2016.
greenlight.guru has partnered with special guest and consultant, Mark Swanson, to keep you ahead of these changes.
Mark spent the last 4 years on the working group that revised the new ISO 13485.
Mark has all the exclusive insider knowledge on the changes you want. And he's going to be sharing it with you for free.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-changes)
In this webinar you'll learn specifically:
-How to prepare for the coming regulatory changes with ISO 13485:2016
-How to apply risk based thinking to your quality processes to ensure compliance
-What you need to know about the design control updates
-How to incorporate ISO 9001:2015 and 13485:2016 to your supplier controls
-A general overview of the standard and its most significant changes (before anyone else)
ИНТЕГРИРАН ПОДХОД ЗА ОСИГУРЯВАНЕ НА СИСТЕМИТЕ ЗА УПРАВЛЕНИЕ НА КАЧЕСТВОТО (С...Светла Иванова
ИНТЕГРИРАН ПОДХОД
ЗА ОСИГУРЯВАНЕ НА СИСТЕМИТЕ ЗА УПРАВЛЕНИЕ НА КАЧЕСТВОТО (СУК), СИГУРНОСТТА НА ИНФОРМАЦИЯТА (СУСИ) И ФИНАНСОВО УПРАВЛЕНИЕ И КОНТРОЛ (СФУК)
A validation programme involves various components in pharmaceutical organisation related to process, equipment and product.
It is a regulatory requirement for pharmaceutical companies to perform Instrument Validation on all new instruments.
Instrument Validation requires detailed knowledge of the instrumentation system being validated and is therefore usually performed by the company supplying the instrument.
PECB Webinar: ISO 9001:2015 Transition – Understanding the changes PECB
This webinar was organized and presented by PECB International to learn about the changes of ISO 9001 standard, which is the world’s most popular standard for quality management.
In this webinar, you will learn about:
• Why ISO 9001 is changing?
• The new ISO 9001 structure
• What are the significant proposed changes?
• Understanding the difference between ISO 9001: 2008 and ISO 9001: 2015
• Planning the QMS transition
• Benefits of the new standard
This webinar was hosted by Lorika Bina, Course Development Manager for Quality Management Systems (QMS) at PECB International. She is in charge of developing and maintaining training courses related to QMS. Lorika holds a B.S. in Business Management from Rochester Institute of Technology.
This is a presentation based on ICH Q10, Pharmaceutical Quality System, It was shared recently with participants of a training session arranged by Ingrope Information Services karachi at marriot Hotel. I am uploading for the benefits of all pharma colleagues, specially the junior ones.
Clover Nutrition is a manufacturer of tea products, herbal extract, functional food. Main Product are Icariin 20%, Lutein 20%, Zeaxanthin 10%, Asataxanthin 2%.
info@clovercn.com www.clovernutrition.com 0086-29-81875649 Xi'an, China
Granulation is the process of collecting particles together by creating bonds between them.
Bonds are formed by compression or by using a binding agent.
Thus, the overall purpose of granulation is to improve the flowability and compressibility of the powder mixture.
Principle: Shear
Construction:
It consist of a mixing bowl, a three-bladed impeller, and an auxiliary chopper.
A. Mixing bowl
Shape – cylindrical or conical
It can be jacketed for heating or cooling the contents in the bowl.
B. Impellers
Function: To mix the dry powder and spread the granulating fluid.
Rotation speed: 100 to 500 rpm range.
C. Chopper
Function: To break down the wet mass to produce granules.
Rotation speed: 1000 to 3000 rpm range.
Principle: Shear
Construction:
It consist of a mixing bowl, a three-bladed impeller, and an auxiliary chopper.
A. Mixing bowl
Shape – cylindrical or conical
It can be jacketed for heating or cooling the contents in the bowl.
B. Impellers
Function: To mix the dry powder and spread the granulating fluid.
Rotation speed: 100 to 500 rpm range.
C. Chopper
Function: To break down the wet mass to produce granules.
Rotation speed: 1000 to 3000 rpm range. Wet Granulation
This includes the following steps:
Loading all the ingredients into the mixing bowl.
Mixing of dry ingredients such as API, filler, and disintegrant, at high impeller and chopper speeds for a short period of time (2–5min).
Addition of a liquid binder (either binder solution or solvent) into the powder mixture, while both the impeller and the chopper are running at a low speed.
Wet massing with both the impeller and the chopper running at a high speed.
Removal of the resulting wet granules from the granulator bowl, and drying them using an appropriate drying technique such as fluid-bed or tray drying.
Sieving the dried granules.
This presentation gives brief information on pelletization, significance of pelletization. Information also cover on formulation aspects of pellets and different existing methods of production of pellets.
SAI Global Webinar: BRC Food Safety Issue 8Switzerland09
In August 2018, the BRC Global Standard for Food Safety will move from issue 7 to issue 8. This is the slide deck from a live webinar on July 9th which shares insight into the changes.
Effective process validation contributes significantly to assuring drug quality. The basic
principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing
ИНТЕГРИРАН ПОДХОД ЗА ОСИГУРЯВАНЕ НА СИСТЕМИТЕ ЗА УПРАВЛЕНИЕ НА КАЧЕСТВОТО (С...Светла Иванова
ИНТЕГРИРАН ПОДХОД
ЗА ОСИГУРЯВАНЕ НА СИСТЕМИТЕ ЗА УПРАВЛЕНИЕ НА КАЧЕСТВОТО (СУК), СИГУРНОСТТА НА ИНФОРМАЦИЯТА (СУСИ) И ФИНАНСОВО УПРАВЛЕНИЕ И КОНТРОЛ (СФУК)
A validation programme involves various components in pharmaceutical organisation related to process, equipment and product.
It is a regulatory requirement for pharmaceutical companies to perform Instrument Validation on all new instruments.
Instrument Validation requires detailed knowledge of the instrumentation system being validated and is therefore usually performed by the company supplying the instrument.
PECB Webinar: ISO 9001:2015 Transition – Understanding the changes PECB
This webinar was organized and presented by PECB International to learn about the changes of ISO 9001 standard, which is the world’s most popular standard for quality management.
In this webinar, you will learn about:
• Why ISO 9001 is changing?
• The new ISO 9001 structure
• What are the significant proposed changes?
• Understanding the difference between ISO 9001: 2008 and ISO 9001: 2015
• Planning the QMS transition
• Benefits of the new standard
This webinar was hosted by Lorika Bina, Course Development Manager for Quality Management Systems (QMS) at PECB International. She is in charge of developing and maintaining training courses related to QMS. Lorika holds a B.S. in Business Management from Rochester Institute of Technology.
This is a presentation based on ICH Q10, Pharmaceutical Quality System, It was shared recently with participants of a training session arranged by Ingrope Information Services karachi at marriot Hotel. I am uploading for the benefits of all pharma colleagues, specially the junior ones.
Clover Nutrition is a manufacturer of tea products, herbal extract, functional food. Main Product are Icariin 20%, Lutein 20%, Zeaxanthin 10%, Asataxanthin 2%.
info@clovercn.com www.clovernutrition.com 0086-29-81875649 Xi'an, China
Granulation is the process of collecting particles together by creating bonds between them.
Bonds are formed by compression or by using a binding agent.
Thus, the overall purpose of granulation is to improve the flowability and compressibility of the powder mixture.
Principle: Shear
Construction:
It consist of a mixing bowl, a three-bladed impeller, and an auxiliary chopper.
A. Mixing bowl
Shape – cylindrical or conical
It can be jacketed for heating or cooling the contents in the bowl.
B. Impellers
Function: To mix the dry powder and spread the granulating fluid.
Rotation speed: 100 to 500 rpm range.
C. Chopper
Function: To break down the wet mass to produce granules.
Rotation speed: 1000 to 3000 rpm range.
Principle: Shear
Construction:
It consist of a mixing bowl, a three-bladed impeller, and an auxiliary chopper.
A. Mixing bowl
Shape – cylindrical or conical
It can be jacketed for heating or cooling the contents in the bowl.
B. Impellers
Function: To mix the dry powder and spread the granulating fluid.
Rotation speed: 100 to 500 rpm range.
C. Chopper
Function: To break down the wet mass to produce granules.
Rotation speed: 1000 to 3000 rpm range. Wet Granulation
This includes the following steps:
Loading all the ingredients into the mixing bowl.
Mixing of dry ingredients such as API, filler, and disintegrant, at high impeller and chopper speeds for a short period of time (2–5min).
Addition of a liquid binder (either binder solution or solvent) into the powder mixture, while both the impeller and the chopper are running at a low speed.
Wet massing with both the impeller and the chopper running at a high speed.
Removal of the resulting wet granules from the granulator bowl, and drying them using an appropriate drying technique such as fluid-bed or tray drying.
Sieving the dried granules.
This presentation gives brief information on pelletization, significance of pelletization. Information also cover on formulation aspects of pellets and different existing methods of production of pellets.
SAI Global Webinar: BRC Food Safety Issue 8Switzerland09
In August 2018, the BRC Global Standard for Food Safety will move from issue 7 to issue 8. This is the slide deck from a live webinar on July 9th which shares insight into the changes.
Effective process validation contributes significantly to assuring drug quality. The basic
principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing
1. VILNIAUS UNIVERSITETO STUDENTŲ ATSTOVYBĖ
REKOMENDACIJA
Dariui Valaičiui
2011-03-21
Darius Valaitis yra Vilniaus universiteto Kauno humanitarinio fakulteto SA laisvalaikio
komiteto vadovas, studijuoja antrame kurse verslo informatiką. Su juo susipažinau „Fuxų“ stovyklos
metu, t.y. 2010 m.rugpjūčio mėn. Paliko šilto, komunikabilaus bei atsidavusio savo tikslui ir darbui
žmogaus įspūdį.
Darius nuoširdžiai rūpinasi savo komiteto narių gerove, skatina juos dar didesniam
tobulėjimui. Puikiai sutaria su dėstytojais ir administracija, dėl šių priežaščių pilnavertiškai atlieka
savo darbą. Jis nuolatos siekia naujovių, tobulina kiekvieną Studentų atstovybės kultūrinį renginį
tam, kad pritrauktų dar daugiau naujų žmonių. Organizuojamomis akcijomis bei renginiais,
laisvalaikio komiteto vadovas garsina mūsų universiteto vardą visame Kaune. Manau Darius rodo
pavyzdį kitų universitetų studentų atstovybių laisvalaikio komitetams.
Šis vaikinas dalyvavo mokymuose ‘‘Savimotyvacija ir lyderystė“- VU KHF SA narių
kompetencijos kėlimo mokymuose. Tai tik parodo, kad šis žmogus pasiryžęs nuolat tobulinti save ir
aplinkinius. Dalyvavo visuose renginiuose skirtuose VU KHF SA gimtadieniui paminėti. Didelį
indėlį paliko 2010m. „Fuxų“ stovyklų metu, praėjusių ir šių metų renginių vedėjas. Daug prisidėjo
prie Studentų atstovybės organizuojamos SEB banko darbuotojų šventės. 2011 metais visi SA
renginiai buvo jo ruošti ir įgyvendinti. Jis visada nusiteikęs padėti ne tik Studentų atstovybės ar savo
komiteto nariams, bet visiems studentams, kuriems iškyla sunkumų. Deda visas pastangas, kad būtų
garbė VU vardui.
VU SA Prezidentas Liutauras Gudžinskas
