�ݺ�ߣshows by User: MdZakariaFaruki

�ݺ�ߣshows by User: MdZakariaFaruki / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: MdZakariaFaruki / Tue, 03 Oct 2023 11:45:35 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: MdZakariaFaruki Pharmacovigilance Function at SPL.pdf /slideshow/pharmacovigilance-function-at-splpdf/261712904 trainingonjobpgv-231003114535-78f3ae7e
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Information received from patients and healthcare providers via pharmacovigilance reporting form as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place.]]>
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Information received from patients and healthcare providers via pharmacovigilance reporting form as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place.]]> Tue, 03 Oct 2023 11:45:35 GMT /slideshow/pharmacovigilance-function-at-splpdf/261712904 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Pharmacovigilance Function at SPL.pdf MdZakariaFaruki Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Information received from patients and healthcare providers via pharmacovigilance reporting form as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/trainingonjobpgv-231003114535-78f3ae7e-thumbnail.jpg?width=120&height=120&fit=bounds" /> Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Information received from patients and healthcare providers via pharmacovigilance reporting form as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place.

Pharmacovigilance Function at SPL.pdf from Md. Zakaria Faruki

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0 Golden Rules of GMP.pdf /slideshow/golden-rules-of-gmppdf/257158063 thetengoldenrulesofgmp-230404105428-0dba5324
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Ref. WHO)]]>
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Ref. WHO)]]> Tue, 04 Apr 2023 10:54:28 GMT /slideshow/golden-rules-of-gmppdf/257158063 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Golden Rules of GMP.pdf MdZakariaFaruki GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Ref. WHO) <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/thetengoldenrulesofgmp-230404105428-0dba5324-thumbnail.jpg?width=120&height=120&fit=bounds" /> GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Ref. WHO)

Golden Rules of GMP.pdf from Md. Zakaria Faruki

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0 Pharmaceutical Quality System .pdf /slideshow/pharmaceutical-quality-system-pdf/257157947 pharmaceuticalqualitysystem-230404104514-fe7ea3d4
The pharmaceutical quality system “assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded...]]>
The pharmaceutical quality system “assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded...]]> Tue, 04 Apr 2023 10:45:14 GMT /slideshow/pharmaceutical-quality-system-pdf/257157947 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Pharmaceutical Quality System .pdf MdZakariaFaruki The pharmaceutical quality system “assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded... <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/pharmaceuticalqualitysystem-230404104514-fe7ea3d4-thumbnail.jpg?width=120&height=120&fit=bounds" /> The pharmaceutical quality system “assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded...

Pharmaceutical Quality System .pdf from Md. Zakaria Faruki

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0 Good Manufacturing Practice for Pharmaceutical Products.pdf /slideshow/good-manufacturing-practice-for-pharmaceutical-productspdf/256888150 goodmanufacturingpracticeforpharmaceuticalproducts-230327090021-6cd2e6df
According to the WHO- "GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification". ]]>
According to the WHO- "GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification". ]]> Mon, 27 Mar 2023 09:00:21 GMT /slideshow/good-manufacturing-practice-for-pharmaceutical-productspdf/256888150 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Good Manufacturing Practice for Pharmaceutical Products.pdf MdZakariaFaruki According to the WHO- "GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification". <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/goodmanufacturingpracticeforpharmaceuticalproducts-230327090021-6cd2e6df-thumbnail.jpg?width=120&height=120&fit=bounds" /> According to the WHO- "GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification".

Good Manufacturing Practice for Pharmaceutical Products.pdf from Md. Zakaria Faruki

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0 CAREER OPPORTUNITIES OF PHARMACY GRADUATES IN THE PHARMACEUTICAL INDUSTRIES.pdf /slideshow/career-opportunities-of-pharmacy-graduates-in-the-pharmaceutical-industriespdf/256839095 careeropportunitiesofpharmacygraduatesinthepharmaceuticalindustries-230325102255-00a45196
Pharmacy is a very important profession, which deals with the manufacturing, handing, proper utilization, dispensing, and administration of life saving drugs. ]]>
Pharmacy is a very important profession, which deals with the manufacturing, handing, proper utilization, dispensing, and administration of life saving drugs. ]]> Sat, 25 Mar 2023 10:22:55 GMT /slideshow/career-opportunities-of-pharmacy-graduates-in-the-pharmaceutical-industriespdf/256839095 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) CAREER OPPORTUNITIES OF PHARMACY GRADUATES IN THE PHARMACEUTICAL INDUSTRIES.pdf MdZakariaFaruki Pharmacy is a very important profession, which deals with the manufacturing, handing, proper utilization, dispensing, and administration of life saving drugs. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/careeropportunitiesofpharmacygraduatesinthepharmaceuticalindustries-230325102255-00a45196-thumbnail.jpg?width=120&height=120&fit=bounds" /> Pharmacy is a very important profession, which deals with the manufacturing, handing, proper utilization, dispensing, and administration of life saving drugs.

CAREER OPPORTUNITIES OF PHARMACY GRADUATES IN THE PHARMACEUTICAL INDUSTRIES.pdf from Md. Zakaria Faruki

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0 Training.pdf /slideshow/trainingpdf-256776561/256776561 training-230323062116-8acb63e3
Training means the process of increasing the knowledge and skills of an employee for doing a particular job. It seeks to improve the job performance and work behaviour of those trained. ]]>
Training means the process of increasing the knowledge and skills of an employee for doing a particular job. It seeks to improve the job performance and work behaviour of those trained. ]]> Thu, 23 Mar 2023 06:21:16 GMT /slideshow/trainingpdf-256776561/256776561 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Training.pdf MdZakariaFaruki Training means the process of increasing the knowledge and skills of an employee for doing a particular job. It seeks to improve the job performance and work behaviour of those trained. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/training-230323062116-8acb63e3-thumbnail.jpg?width=120&height=120&fit=bounds" /> Training means the process of increasing the knowledge and skills of an employee for doing a particular job. It seeks to improve the job performance and work behaviour of those trained.

Training.pdf from Md. Zakaria Faruki

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0 Process Validation.pdf /slideshow/process-validationpdf/255623285 processvalidationspl-230131092244-f584bb84
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.]]>
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.]]> Tue, 31 Jan 2023 09:22:44 GMT /slideshow/process-validationpdf/255623285 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Process Validation.pdf MdZakariaFaruki Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/processvalidationspl-230131092244-f584bb84-thumbnail.jpg?width=120&height=120&fit=bounds" /> Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.

Process Validation.pdf from Md. Zakaria Faruki

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0 Workshop on General Accident Prevention at The workplaces.pdf /slideshow/workshop-on-general-accident-prevention-at-the-workplacespdf/254083010 workshopongapig-221109033637-11be91d6
Providing a safe environment for employees is one of the most important responsibilities of a management team. In industries with inherent risks, like construction and mining, it's crucial that employees understand and follow the proper safety protocols. In addition, preventing job accidents call for various strategies. The organization should have a comprehensive education of the workers, proper risk management, introducing safety alerts in the establishments, security leaders, and ensuring that the workers are in a stable psychological and mental state. Moreover, developing and enforcing safety plans in the organization can provide greater peace of mind for employees and help prevent accidents and injuries. In this Workshop, we discussed what accident prevention in the workplace is and provide tips for maintaining a safe workplace. Therefore, please follow the safety guidelines accordingly to prevent the accident in the workplace. ]]>
Providing a safe environment for employees is one of the most important responsibilities of a management team. In industries with inherent risks, like construction and mining, it's crucial that employees understand and follow the proper safety protocols. In addition, preventing job accidents call for various strategies. The organization should have a comprehensive education of the workers, proper risk management, introducing safety alerts in the establishments, security leaders, and ensuring that the workers are in a stable psychological and mental state. Moreover, developing and enforcing safety plans in the organization can provide greater peace of mind for employees and help prevent accidents and injuries. In this Workshop, we discussed what accident prevention in the workplace is and provide tips for maintaining a safe workplace. Therefore, please follow the safety guidelines accordingly to prevent the accident in the workplace. ]]> Wed, 09 Nov 2022 03:36:37 GMT /slideshow/workshop-on-general-accident-prevention-at-the-workplacespdf/254083010 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Workshop on General Accident Prevention at The workplaces.pdf MdZakariaFaruki Providing a safe environment for employees is one of the most important responsibilities of a management team. In industries with inherent risks, like construction and mining, it's crucial that employees understand and follow the proper safety protocols. In addition, preventing job accidents call for various strategies. The organization should have a comprehensive education of the workers, proper risk management, introducing safety alerts in the establishments, security leaders, and ensuring that the workers are in a stable psychological and mental state. Moreover, developing and enforcing safety plans in the organization can provide greater peace of mind for employees and help prevent accidents and injuries. In this Workshop, we discussed what accident prevention in the workplace is and provide tips for maintaining a safe workplace. Therefore, please follow the safety guidelines accordingly to prevent the accident in the workplace. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/workshopongapig-221109033637-11be91d6-thumbnail.jpg?width=120&height=120&fit=bounds" /> Providing a safe environment for employees is one of the most important responsibilities of a management team. In industries with inherent risks, like construction and mining, it's crucial that employees understand and follow the proper safety protocols. In addition, preventing job accidents call for various strategies. The organization should have a comprehensive education of the workers, proper risk management, introducing safety alerts in the establishments, security leaders, and ensuring that the workers are in a stable psychological and mental state. Moreover, developing and enforcing safety plans in the organization can provide greater peace of mind for employees and help prevent accidents and injuries. In this Workshop, we discussed what accident prevention in the workplace is and provide tips for maintaining a safe workplace. Therefore, please follow the safety guidelines accordingly to prevent the accident in the workplace.

Workshop on General Accident Prevention at The workplaces.pdf from Md. Zakaria Faruki

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0 Personnel.pdf /slideshow/personnelpdf-252694193/252694193 personnel-220825080711-e4da2973
The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked. The technical people must have a knowledge and understanding of GMP to enable them to carry out their duties in accordance with GMP. These people must have the level of training and experience that will enable them to do their professional works respectively. ]]>
The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked. The technical people must have a knowledge and understanding of GMP to enable them to carry out their duties in accordance with GMP. These people must have the level of training and experience that will enable them to do their professional works respectively. ]]> Thu, 25 Aug 2022 08:07:11 GMT /slideshow/personnelpdf-252694193/252694193 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Personnel.pdf MdZakariaFaruki The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked. The technical people must have a knowledge and understanding of GMP to enable them to carry out their duties in accordance with GMP. These people must have the level of training and experience that will enable them to do their professional works respectively. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/personnel-220825080711-e4da2973-thumbnail.jpg?width=120&height=120&fit=bounds" /> The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked. The technical people must have a knowledge and understanding of GMP to enable them to carry out their duties in accordance with GMP. These people must have the level of training and experience that will enable them to do their professional works respectively.

Personnel.pdf from Md. Zakaria Faruki

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0 Product Recall.pdf /slideshow/product-recallpdf/252258355 productrecalltrainingslides-220721022044-770a6266
According to US FDA it is illustrated here that,  A recall is a method of removing or correcting products that are in violation of laws administered by the Drug Regulatory Authority.  Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.  21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.]]>
According to US FDA it is illustrated here that,  A recall is a method of removing or correcting products that are in violation of laws administered by the Drug Regulatory Authority.  Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.  21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.]]> Thu, 21 Jul 2022 02:20:43 GMT /slideshow/product-recallpdf/252258355 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Product Recall.pdf MdZakariaFaruki According to US FDA it is illustrated here that,  A recall is a method of removing or correcting products that are in violation of laws administered by the Drug Regulatory Authority.  Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.  21 CFR 7 provides guidance so that responsible firms may conduct an effective recall. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/productrecalltrainingslides-220721022044-770a6266-thumbnail.jpg?width=120&height=120&fit=bounds" /> According to US FDA it is illustrated here that,  A recall is a method of removing or correcting products that are in violation of laws administered by the Drug Regulatory Authority.  Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.  21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.

Product Recall.pdf from Md. Zakaria Faruki

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0 Market Complaint.pdf /slideshow/market-complainttraining-presentationpdf/252069323 marketcomplainttrainingpresentation-220627110404-80789146
Market or Customer complaint is “an expression of dis-satisfaction on a customer’s behalf to a responsible party” when their expectations have not been met! However, Complaint handling is a Good Manufacturing Practice (GMP) requirement, since all complaints concerning potentially defective products must be carefully reviewed according to a written procedure.]]>
Market or Customer complaint is “an expression of dis-satisfaction on a customer’s behalf to a responsible party” when their expectations have not been met! However, Complaint handling is a Good Manufacturing Practice (GMP) requirement, since all complaints concerning potentially defective products must be carefully reviewed according to a written procedure.]]> Mon, 27 Jun 2022 11:04:04 GMT /slideshow/market-complainttraining-presentationpdf/252069323 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Market Complaint.pdf MdZakariaFaruki Market or Customer complaint is “an expression of dis-satisfaction on a customer’s behalf to a responsible party” when their expectations have not been met! However, Complaint handling is a Good Manufacturing Practice (GMP) requirement, since all complaints concerning potentially defective products must be carefully reviewed according to a written procedure. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/marketcomplainttrainingpresentation-220627110404-80789146-thumbnail.jpg?width=120&height=120&fit=bounds" /> Market or Customer complaint is “an expression of dis-satisfaction on a customer’s behalf to a responsible party” when their expectations have not been met! However, Complaint handling is a Good Manufacturing Practice (GMP) requirement, since all complaints concerning potentially defective products must be carefully reviewed according to a written procedure.

Market Complaint.pdf from Md. Zakaria Faruki

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0 Good Documentation Practice (GDocP).pdf /slideshow/good-documentation-practice-gdocppdf/251569662 gooddocumentationpracticegdocp-220412083848
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document. ]]>
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document. ]]> Tue, 12 Apr 2022 08:38:47 GMT /slideshow/good-documentation-practice-gdocppdf/251569662 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Good Documentation Practice (GDocP).pdf MdZakariaFaruki Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/gooddocumentationpracticegdocp-220412083848-thumbnail.jpg?width=120&height=120&fit=bounds" /> Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.

Good Documentation Practice (GDocP).pdf from Md. Zakaria Faruki

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0 Current Good Manufacturing Practice (cGMP) /slideshow/current-good-manufacturing-practice-cgmp-251554136/251554136 fundamentalsofcgmpmzf-220410084726
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO) In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.]]>
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO) In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.]]> Sun, 10 Apr 2022 08:47:26 GMT /slideshow/current-good-manufacturing-practice-cgmp-251554136/251554136 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Current Good Manufacturing Practice (cGMP) MdZakariaFaruki GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO) In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/fundamentalsofcgmpmzf-220410084726-thumbnail.jpg?width=120&height=120&fit=bounds" /> GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO) In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.

Current Good Manufacturing Practice (cGMP) from Md. Zakaria Faruki

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0 Bio-equivalence and Bio-similarity studies of Drugs /slideshow/bioequivalence-and-biosimilarity-studies-of-drugs/215098014 bebsstudyofdrugzakaria-200104040830
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. The first generation of biological drugs, which have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars. ]]>
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. The first generation of biological drugs, which have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars. ]]> Sat, 04 Jan 2020 04:08:30 GMT /slideshow/bioequivalence-and-biosimilarity-studies-of-drugs/215098014 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Bio-equivalence and Bio-similarity studies of Drugs MdZakariaFaruki Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. The first generation of biological drugs, which have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/bebsstudyofdrugzakaria-200104040830-thumbnail.jpg?width=120&height=120&fit=bounds" /> Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same. The first generation of biological drugs, which have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars.

Bio-equivalence and Bio-similarity studies of Drugs from Md. Zakaria Faruki

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0 Good Clinical Practice and Pharmacovigilance /MdZakariaFaruki/good-clinical-practice-and-pharmacovigilance presentationgcppvbyzakaria-190912025157
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.]]>
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.]]> Thu, 12 Sep 2019 02:51:57 GMT /MdZakariaFaruki/good-clinical-practice-and-pharmacovigilance MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Good Clinical Practice and Pharmacovigilance MdZakariaFaruki GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/presentationgcppvbyzakaria-190912025157-thumbnail.jpg?width=120&height=120&fit=bounds" /> GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Good Clinical Practice and Pharmacovigilance from Md. Zakaria Faruki

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0 Stability study of Pharmaceutical Products and Regulatory Requirements /slideshow/stability-study-of-pharmaceutical-products-and-regulatory-requirements/126580071 stabilitystudyoffpp-181223154949
A marketed product stability program fulfills registration commitments and ensures that marketed product is stable until expiry date stamped on product label.... Stability studies should be planned on the basis of pharmaceutical R&D and regulatory requirements...]]>
A marketed product stability program fulfills registration commitments and ensures that marketed product is stable until expiry date stamped on product label.... Stability studies should be planned on the basis of pharmaceutical R&D and regulatory requirements...]]> Sun, 23 Dec 2018 15:49:49 GMT /slideshow/stability-study-of-pharmaceutical-products-and-regulatory-requirements/126580071 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Stability study of Pharmaceutical Products and Regulatory Requirements MdZakariaFaruki A marketed product stability program fulfills registration commitments and ensures that marketed product is stable until expiry date stamped on product label.... Stability studies should be planned on the basis of pharmaceutical R&D and regulatory requirements... <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/stabilitystudyoffpp-181223154949-thumbnail.jpg?width=120&height=120&fit=bounds" /> A marketed product stability program fulfills registration commitments and ensures that marketed product is stable until expiry date stamped on product label.... Stability studies should be planned on the basis of pharmaceutical R&D and regulatory requirements...

Stability study of Pharmaceutical Products and Regulatory Requirements from Md. Zakaria Faruki

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0 Post Marketing Drug Safety & Pharmacovigilance /slideshow/post-marketing-drug-safety-pharmacovigilance/121796142 postmarketingdrugsafetypharmacovigilance-181104140713
Post-marketing drug safety surveillance refers to the monitoring of drugs once they reach the market after clinical trials through a process which evaluates drugs taken by individuals under a wide range of circumstances over an extended period. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. ]]>
Post-marketing drug safety surveillance refers to the monitoring of drugs once they reach the market after clinical trials through a process which evaluates drugs taken by individuals under a wide range of circumstances over an extended period. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. ]]> Sun, 04 Nov 2018 14:07:13 GMT /slideshow/post-marketing-drug-safety-pharmacovigilance/121796142 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Post Marketing Drug Safety & Pharmacovigilance MdZakariaFaruki Post-marketing drug safety surveillance refers to the monitoring of drugs once they reach the market after clinical trials through a process which evaluates drugs taken by individuals under a wide range of circumstances over an extended period. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/postmarketingdrugsafetypharmacovigilance-181104140713-thumbnail.jpg?width=120&height=120&fit=bounds" /> Post-marketing drug safety surveillance refers to the monitoring of drugs once they reach the market after clinical trials through a process which evaluates drugs taken by individuals under a wide range of circumstances over an extended period. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

Post Marketing Drug Safety & Pharmacovigilance from Md. Zakaria Faruki

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0 Drug Development and Clinical Studies /slideshow/drug-development-and-clinical-studies/107562734 trainingondrugdevelopmentoplpdf-180726055041
Training on Drug Development & Clinical Studies]]>
Training on Drug Development & Clinical Studies]]> Thu, 26 Jul 2018 05:50:41 GMT /slideshow/drug-development-and-clinical-studies/107562734 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Drug Development and Clinical Studies MdZakariaFaruki Training on Drug Development & Clinical Studies <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/trainingondrugdevelopmentoplpdf-180726055041-thumbnail.jpg?width=120&height=120&fit=bounds" /> Training on Drug Development & Clinical Studies

Drug Development and Clinical Studies from Md. Zakaria Faruki

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0 Electronic Common Technical Document (eCTD) /slideshow/electronic-common-technical-document-ectd/107560175 presentationectdzakariapdf-180726052313
Pharmaceutical Product Registration by eCTD]]>
Pharmaceutical Product Registration by eCTD]]> Thu, 26 Jul 2018 05:23:13 GMT /slideshow/electronic-common-technical-document-ectd/107560175 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) Electronic Common Technical Document (eCTD) MdZakariaFaruki Pharmaceutical Product Registration by eCTD <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/presentationectdzakariapdf-180726052313-thumbnail.jpg?width=120&height=120&fit=bounds" /> Pharmaceutical Product Registration by eCTD

Electronic Common Technical Document (eCTD) from Md. Zakaria Faruki

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0 PRODUCT REGISTRATION IN THE GLOBAL MARKET WITH CTD /slideshow/product-registration-in-the-global-market-with-ctd/107558373 trainingonctdorion-180726050220
Common Technical Document (CTD)]]>
Common Technical Document (CTD)]]> Thu, 26 Jul 2018 05:02:20 GMT /slideshow/product-registration-in-the-global-market-with-ctd/107558373 MdZakariaFaruki@slideshare.net(MdZakariaFaruki) PRODUCT REGISTRATION IN THE GLOBAL MARKET WITH CTD MdZakariaFaruki Common Technical Document (CTD) <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/trainingonctdorion-180726050220-thumbnail.jpg?width=120&height=120&fit=bounds" /> Common Technical Document (CTD)

PRODUCT REGISTRATION IN THE GLOBAL MARKET WITH CTD from Md. Zakaria Faruki

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0 https://cdn.slidesharecdn.com/profile-photo-MdZakariaFaruki-48x48.jpg?cb=1732766630 To ensure product quality by establishing the Quality Management System and implementing Good Manufacturing Practices in the manufacturing Plant & Distribution. Providing leadership and direction to the QA & QC Teams. Ensuring that the all the Departments are staffed and equipped to effectively carry out the service required as per the cGMP compliance. scholar.google.com/citations?hl=en&user=jvzAKIoAAAAJ&fbclid=IwAR3BevWFgGGfg6T7C33ujvrM2WrK_sB_VWZl4XSIc4mae-J4bz83O7S3yMc https://cdn.slidesharecdn.com/ss_thumbnails/trainingonjobpgv-231003114535-78f3ae7e-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/pharmacovigilance-function-at-splpdf/261712904 Pharmacovigilance Func... https://cdn.slidesharecdn.com/ss_thumbnails/thetengoldenrulesofgmp-230404105428-0dba5324-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/golden-rules-of-gmppdf/257158063 Golden Rules of GMP.pdf https://cdn.slidesharecdn.com/ss_thumbnails/pharmaceuticalqualitysystem-230404104514-fe7ea3d4-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/pharmaceutical-quality-system-pdf/257157947 Pharmaceutical Quality...