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DATA KELUARAN TOGEL SINGAPURA 2016
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http://www.dukunsantet.com/
DATA PENGELUARAN TOGEL SINGAPURA 2016
DATA KELUARAN TOGEL SINGAPURA 2016
Data pengeluaran togel singapura 2015 Sampai 2016 | data pengeluaran togel sgp 2016 | data pengeluaran togel singapura 2016
http://www.dukunsantet.com/
List of Provisional Registered Participants Hubdar Ali
11- b & c
(who are our priority but not yet submitted home work, we encourage to submit as early as possible or by coming Friday)
Please check and respond in comment box if your name is highlighted in grey
Participant has to fill confirmation through google form when asked. Please wait and keep visiting page on daily basis
11- a (who have successfully submitted homework)
Participant has to fill confirmation through google form when asked. Please wait and keep visiting page on daily basis
This document contains a list of 376 registered participants for an event. It includes each participant's name and a unique participant code. The list is alphabetized by participant last name.
Roohi Bano Obaid, Deputy Director of the Drug Regulatory Authority of Pakistan, opened a discussion forum on ICH Q7 and Q11 guidelines. She thanked the participants for their patience during registration and determination to learn. The previous discussion saw overwhelming participation of 470 people, so this follow-up event was organized for those unable to attend. Obaid emphasized the importance of sharing knowledge with honesty and building a robust quality system through respecting science. She wished the participants a wonderful day of learning and looked forward to future knowledge sharing exercises.
The document discusses control strategies for pharmaceutical manufacturing processes as outlined in ICH Q7 and Q11 guidelines. It notes that control strategies should be based on current product and process understanding to ensure quality and performance. Traditionally, control strategies focused on set points and operating ranges, but an enhanced approach calls for more systematic identification of variability sources, increased process understanding, and flexibility in operating parameters. The document also assigns a 10-hour take-home assignment analyzing control strategies and case studies of API manufacturing failures.
This document summarizes a discussion forum on ICH Q7 & Q11 regarding DMFs, impurities, CTD, and challenges. It provides an outline of drug master files, types of DMFs, classes of impurities in APIs, elements of a control strategy, sections of the common technical document that contain established conditions, and challenges faced. The presentation focused on established conditions, control strategies, their relationship, and how established conditions are presented in CTD sections.
This document summarizes a presentation on the development and qualification of suppliers. It discusses the importance of auditing suppliers to ensure quality and prevent issues like contamination or non-compliance. The presentation outlines key aspects of auditing like reviewing documentation, inspecting facilities, and assessing quality management. It argues audits are necessary to detect issues and ensure a safe supply chain, as systems based solely on trusting suppliers through questionnaires or virtual audits are not sufficient. The presentation closes by urging companies to prioritize quality and safety over profits to prevent irreversible harm.
The document discusses perspectives on ICH Q7 and Q11 from scientific and regulatory viewpoints. It summarizes common GMP deficiencies observed during API inspections, including inadequate vendor audits that failed to properly evaluate supplier quality systems and cleaning procedures. Specific examples call out insufficient control of API starting materials due to unacceptable facility maintenance and lack of testing, as well as inadequate sampling and improper storage of materials.
This document discusses approaches to implementing ICH Q7 and Q11 guidelines. It covers key aspects of good manufacturing practices including quality management, personnel, facilities, equipment, documentation, materials, production, packaging, storage, laboratories, validation, change control, rejection and re-use, complaints and recall, and responsibilities of external organizations. The goal is to help ensure quality and compliance in pharmaceutical manufacturing.
This document discusses an interactive discussion forum on ICH Q7 and Q11 guidelines for good manufacturing practices. The discussion focused on whether a drug product can ensure safety if manufactured from a non-compliant active pharmaceutical ingredient. Participants also considered whether good manufacturing practices are required for pharmaceutical ingredients, processes, and products.
List of Provisional Registered Participants Hubdar Ali
11- b & c
(who are our priority but not yet submitted home work, we encourage to submit as early as possible or by coming Friday)
Please check and respond in comment box if your name is highlighted in grey
Participant has to fill confirmation through google form when asked. Please wait and keep visiting page on daily basis
11- a (who have successfully submitted homework)
Participant has to fill confirmation through google form when asked. Please wait and keep visiting page on daily basis
This document contains a list of 376 registered participants for an event. It includes each participant's name and a unique participant code. The list is alphabetized by participant last name.
Roohi Bano Obaid, Deputy Director of the Drug Regulatory Authority of Pakistan, opened a discussion forum on ICH Q7 and Q11 guidelines. She thanked the participants for their patience during registration and determination to learn. The previous discussion saw overwhelming participation of 470 people, so this follow-up event was organized for those unable to attend. Obaid emphasized the importance of sharing knowledge with honesty and building a robust quality system through respecting science. She wished the participants a wonderful day of learning and looked forward to future knowledge sharing exercises.
The document discusses control strategies for pharmaceutical manufacturing processes as outlined in ICH Q7 and Q11 guidelines. It notes that control strategies should be based on current product and process understanding to ensure quality and performance. Traditionally, control strategies focused on set points and operating ranges, but an enhanced approach calls for more systematic identification of variability sources, increased process understanding, and flexibility in operating parameters. The document also assigns a 10-hour take-home assignment analyzing control strategies and case studies of API manufacturing failures.
This document summarizes a discussion forum on ICH Q7 & Q11 regarding DMFs, impurities, CTD, and challenges. It provides an outline of drug master files, types of DMFs, classes of impurities in APIs, elements of a control strategy, sections of the common technical document that contain established conditions, and challenges faced. The presentation focused on established conditions, control strategies, their relationship, and how established conditions are presented in CTD sections.
This document summarizes a presentation on the development and qualification of suppliers. It discusses the importance of auditing suppliers to ensure quality and prevent issues like contamination or non-compliance. The presentation outlines key aspects of auditing like reviewing documentation, inspecting facilities, and assessing quality management. It argues audits are necessary to detect issues and ensure a safe supply chain, as systems based solely on trusting suppliers through questionnaires or virtual audits are not sufficient. The presentation closes by urging companies to prioritize quality and safety over profits to prevent irreversible harm.
The document discusses perspectives on ICH Q7 and Q11 from scientific and regulatory viewpoints. It summarizes common GMP deficiencies observed during API inspections, including inadequate vendor audits that failed to properly evaluate supplier quality systems and cleaning procedures. Specific examples call out insufficient control of API starting materials due to unacceptable facility maintenance and lack of testing, as well as inadequate sampling and improper storage of materials.
This document discusses approaches to implementing ICH Q7 and Q11 guidelines. It covers key aspects of good manufacturing practices including quality management, personnel, facilities, equipment, documentation, materials, production, packaging, storage, laboratories, validation, change control, rejection and re-use, complaints and recall, and responsibilities of external organizations. The goal is to help ensure quality and compliance in pharmaceutical manufacturing.
This document discusses an interactive discussion forum on ICH Q7 and Q11 guidelines for good manufacturing practices. The discussion focused on whether a drug product can ensure safety if manufactured from a non-compliant active pharmaceutical ingredient. Participants also considered whether good manufacturing practices are required for pharmaceutical ingredients, processes, and products.
This document discusses ICH Q7 and Q11 guidelines for good manufacturing practices for active pharmaceutical ingredients. It defines key terms like starting material and active pharmaceutical ingredient. It also discusses characteristics that must be evaluated for active pharmaceutical ingredients like elucidation of structure, impurities, specifications and analytical validation. The document contrasts traditional and enhanced approaches to development and manufacturing under ICH Q11, noting the traditional approach relies on set points, operating ranges and release based on meeting criteria, while the enhanced approach uses greater science and risk knowledge to identify critical quality attributes and develop a control strategy.
List of Registered Participants (program b)Hubdar Ali
This document contains a list of 202 registered participants for ICH Q7 & ICH Q11 (Program B) on May 21, 2017. It includes each participant's name, years of experience, and participant code. The experience levels range from 0-3 years to 20 years and above.
The document discusses Iraq's challenges since the 2003 US-UK invasion, including economic crisis, political and social crisis, sectarian and ethnic crisis, and threats to territorial integrity. It notes the UN's reluctance to endorse the invasion but current efforts to maintain peace and prosperity. It also outlines Iraq's efforts to revive its economy following ISIS attacks in 2014 through increasing oil exports. The document argues Iraq must address economic reconstruction, humanitarian concerns, and issues of governance, rights, transparency, and decentralization to progress in the 21st century global environment.