Mark Corson

By G. Lukar. American Academy of Art. 2018.

The targeted time lines and subsequent actions for disposal of the applications received in the office of zonal/sub-zonal offices is as follows: - Nature of Targeted time First response & application lines Action to be taken Grant or Targeted time line In case some renewal of should be 21 deficiencies are Blood Bank working days from observed in the license buy vardenafil 10 mg amex erectile dysfunction caffeine. Grant or Targeted time line In case some renewal of should be 30 deficiencies in the Vaccine working days from documents is manufacturing the date of observed buy vardenafil 10 mg free shipping erectile dysfunction brands, notice of licenses submission of the compliance should be application for forwarded to the scrutiny of the applicants within this documents order vardenafil 20mg without prescription impotence existing at the time of the marriage. Grant or Targeted time line In case some renewal of should be 21 deficiencies in the Medical working days from documents is Devices the date of observed, notice of Manufacturing submission of the compliance should be licenses application for forwarded to the scrutiny of the applicants within this documents. Approval of Targeted time line In case some Institution for should be 21 deficiencies in the carrying out working days from documents is Test on the date of observed, notice of Drugs, submission of the compliance should be Cosmetics application for forwarded to the and Raw scrutiny of the applicants within this materials as documents. Grant or Targeted time line In case some renewal of should be 30 deficiencies in the Bio-Tech/Bio- working days from documents is similar the date of observed, notice of products submission of the compliance should be manufacturing application for forwarded to the licenses scrutiny of the applicants within this documents. If after scrutiny, the documents are found in order, the zonal officer should instruct the concerned technical staff to propose for a joint inspection to the State Licensing Authority. After the inspection date is proposed and the inspection was allotted to a particular inspector, the concerned file along with all the documents including observations checklist should be handed over to the concerned Drugs Inspector for joint inspection. The concerned file along with the copy of joint inspection report should be 14 submitted by the Drugs Inspector to the zonal / sub-zonal officer as the earliest. The zonal / sub-zonal officer should go through the report and record his observations on the report in writing and further necessary action as deemed fit shall be initiated by him. Therefore, all zonal & sub-zonal office should frame a plan to draw samples of Drugs & Cosmetics under the Act at regular interval from various distribution points. Each Drugs inspector shall collect at least 5 samples per month under the Drug and Cosmetics Act for testing. The sample shall be preferably collected from Government dispensaries, hospitals, rural outlets and from manufacturing premises during inspection. It is pertinent to mention here that the Drugs Inspector shall collect the samples as per the provisions of Drugs & Cosmetics Act only and survey samples may be collected when it is warranted for a specific purpose as directed. In case the samples collected under survey is declared as Not of Standard Quality, no further action can be initiated without drawing the samples under section 23 of the said 15 Act. Since, the Drugs Inspectors always collect the samples after disclosing his / her identity, hence the drugs samples should be collected only as specified under the Act. Survey samples should be drawn through Drugs Samplers who purchase the samples concealing his identity, which can further be sampled by an inspector under the Act, if requirements. As a policy matter each drugs sampler may be given a target of purchasing at least 20 samples per month from the fast moving and generic products. Zonal & sub-zonal office receive complaints from some agencies and stake holders regarding movement of spurious/sub-standard drugs. If a spurious or sub-standard is detected by zonal or sub- zonal office, utmost care should be taken to connect the manufacturer through all distribution channel from the source of collection of the impugned drug. The moment manufacturer involvement is established, the documented evidence collected in this regard should immediately be sent to the 16 concerned zonal officer under whose jurisdiction the manufacturing unit is located for further investigation through the Drugs Inspector of the said zone. It is advisable not to send the Drugs Inspector directly to the manufacturing unit or to the concerned State Licensing Authority for investigation without connecting the manufacturer with proper documented evidence. Procedures to be adapted by the zonal officers to discharge the following functions that has been delegated recently by the Drugs Controller General of India under Rule 22 of the Drugs & Cosmetic Rules 1. Objection certificate for the grant of licence to manufacture drugs for the purpose of examination, test or analysis and provided under Rule 89 of the Drugs & Cosmetic Rules. Objection certificate for the grant of permission for manufacture for export only of unapproved/ approved new drugs and drugs banned under section 26-A of the Drugs & Cosmetic Act. Issue of Permit for import of small quantities of drugs for personal use under Form-12B of the Drugs & Cosmetic Rules. Objection certificate for the grant of permission for import of dual use items, not for medicinal use. Other activities (workshop, seminar, meetings, trainings organized / attended) 20 350 300 250 200 150 100 50 0 Other Activities No. Compliance verification inspection to authenticate the results of corrective actions. A review should be made relating to the firm to be visited from the documents available in the office file. Communication with the Local Authority for access to the site of inspection and regarding the Schedule of inspection. Inspector shall act according to the procedures for handling of confidential information. All information observed or passed to the inspector is confidential and shall not be disclosed to anybody other than his controlling authority. Inspector shall neither carry with him any written or printed materials relating to other units nor disclose any information relating to another company. The inspector’s task is not only to point out deficiencies but also to provide guidance based on scientific evidence. At the opening session:- The inspection usually begins with a meeting between the inspector(s), representatives of the firm or plant management and those responsible for the product or areas to be inspected. The inspection team shall give a written day wise plan for the inspection schedule as per Annexure- A 5. The inspector(s) shall inform to the firm management to ensure presence of concerned in-charge of the respective areas as per inspection plan. The inspectors shall state which documents they need to examine once they have completed their preliminary tour of the site.

Number of generated substructures for each source set and chemical representation buy vardenafil 10 mg on-line erectile dysfunction johnson city tn. Activity Range [a] Representation pKi ≥ 8 pKi ≥ 5 5 ≤ pKi < 8 Normal 4 purchase vardenafil 10mg without a prescription impotence 60 years old,424 471 408 Ar generic 10mg vardenafil free shipping erectile dysfunction causes heart disease. Examples of discriminative substructures for high-affinity adenosine A2A antagonists versus drug-like background compounds. Note that the provided examples are all within the set of the 50 top ranking substructures. A2A Background Score Nr Substructure antagonists compounds contribution a N N 242 (94. Note that the provided examples are all within the set of the 50 top ranking substructures (described below). All substructures in Table 2 are also present in compound 1 (note that substructures may overlap). For two of these substructures, c and d of Table 2, this is illustrated in Figure 2. This figure shows one example of how substructures are positioned in the molecules they originate from. Note that the methanediamine substructure, c, occurs three times in compound 1 (and also once in compound 3 and twice in compound 2, Figure 1). For frequency calculations, however, it was counted 153 Chapter 5 only once per molecule. Substructures c and d each represent one of two types of substructures that exist: substructures that are clear molecular fragments such as rings and functional groups (d) and substructures that have an unspecified shape (c). The structure of compound 1 with two examples of discriminative substructures for A2A antagonists highlighted in bold. For each frequent substructure in the antagonist set, the occurrence in the background set was also determined. For instance, substructure c in Table 2 occurred in 247 of the 255 A2A antagonists, or 96. Since these substructures are frequently occurring in the A2A antagonists and infrequently in background compounds they are signified as ‘discriminative’ for A2A antagonists. This discriminative property is quantified by calculating the difference between the fraction of antagonists and the fraction of background compounds in which the substructures occur. This difference is referred to as ‘score contribution’ of a substructure and is used to rank the substructures. The top-ranked substructures, those with the highest score contribution, are the most ‘discriminative’ ones and were subsequently used for the screening. This is because the frequency of a in the background set is considerably lower than that of b, resulting in a higher score contribution for a. Compounds with the highest score were considered more likely to be A2A antagonists. The first two sets consisted of the top 50 and the top 100 of the ranked substructures. The third set consisted of substructures ranked at positions 51 to 100 and served to investigate the impact of substructure ranking on screening. Three different methods of score calculation were tested: first, simple counting of substructures that match the chemical structure of a screening compound; second, summation of the score contributions of the matching substructures; third, multiplication of (the score contribution + 1) of all matching substructures. Table 4 shows an example of score calculation based on the seven substructures from Table 2. Scores were calculated for one reference A2A antagonist (compound 4) and one decoy compound (compound 5). The presence of substructures (rows) in one of the compounds (columns) is indicated by a mark. In the last row, the calculated scores for each of the aforementioned calculation methods are stated: counting, summation, and multiplication. Ranking the compounds based on this score thus results in the reference A2A antagonist (compound 4) being ranked higher than the drug-like decoy (compound 5). First, 155 Chapter 5 compounds were ranked according to the calculated score; then, a subset of compounds was selected from the top down. The true positive rate (sensitivity) was plotted against the false positive rate (1 – specificity). The best performing model consisted of the 100 top-ranked substructures derived from the high-affinity antagonist set represented in normal chemical representation, with ‘multiplied’ score calculation. The worst performing model consisted of the substructures derived from the high-affinity antagonist set in ‘Planar’ representation that were ranked at position 51 to 100, with either one of the three types of score calculation. Representation pKi ≥ 8 pKi ≥ 5 5 ≤ pKi < 8 / Score type 1-100 1-50 51-100 1-100 1-50 51-100 1-100 1-50 51-100 Normal Counts 0. For this, compounds from the ChemDiv Screening Compounds collection with molecular weight below 500 Dalton were used. This ChemDiv library represents an extensive collection of chemically diverse organic molecules. Each compound was given a score based on multiplication of each (score contribution + 1), for all the substructures that were present in the molecular structure of that compound. These substructures not only match the unsubstituted furan moiety but all substitution patterns of the furan ring, hence the extra filtering step. The remaining compounds were ranked according to score, and the top 1800 compounds with the highest score were considered as potential hits.

In training graduate students National university of pharmacy vardenafil 10 mg with amex erectile dysfunction caused by spinal stenosis, which mostly do not have basic pedagogical education cheap vardenafil 10mg mastercard erectile dysfunction treatment implant video, cheap vardenafil 20 mg with amex erectile dysfunction protocol video, teaching practice is a significant, the main purpose of teaching is formation of readiness of future teachers of the university for research and teaching. During the psychological and pedagogical training are specified the following principles: individual importance of knowledge, abilities and skills acquired by a teacher; the availability of consistent information about the nature and structure, functions of pedagogical activity; consistent transition from learning (through modeling professional) to professional teaching practices; and the problematic of dialogical communication in the system «student-teacher» and «student-student»; individualization and differentiation of the content of psychological and pedagogical training technologies of educational process organization; gaming simulation and role- playing perspective; the unity of teaching and upbringing, development and improvement; openness to learning (a harmonious combination of various learning technologies both traditional and innovative – there is a harmonious combination of different forms of work: lectures, practical, independent, types of consultations, learning from each other (collective, group, ScrollPane cooperative learning). Introduced Dialogic approach and different teaching technologies in the process of psycho-pedagogical training of graduate students affect the formation not only of theoretical and motivational readiness in a specified plane problems, but necessary and practical readiness of future teachers, the level of which certainly confirmed a fairly high rate of reporting of individual tasks: analysis of the leading methods of teaching; design and implementation of methodologies for the conduct of practical, seminar or laboratory work; presentation skills. In the leading ways of formation of readiness of graduate students for research and teaching include: the formation of identity of future teacher; formation of the orientation of the personality of a future teacher in the creative exercise of their professional activities; formation of the necessary complex of professional knowledge, abilities and skills for creative professional activity of the teacher; formation of practical professional activity of a teacher. The studied psycho-pedagogical knowledge of the graduate students, methodology of pedagogy and research as possible will contribute to the development of their professional-personal potential, the formation of the image of the teacher-researcher, which undoubtedly will evolve and improve themselves during the execution of their professional activities. Nowadays in heavy flow of information and its transformation into an important strategic resource of mankind the formation of personality capable of self-education throughout life, guided in modern informational space is one of the important tasks of high school. At the same time in higher education institutions the problem of training future teachers to organize the students‘ individual work in the conditions of existing informational environment is not given much attention. The aim of the research is to determine the pedagogical conditions of future teachers‘ skills formation in the students‘ individual work in the modern informational environment. To address the goal the following methods of scientific research have been used: analysis of psychological and educational literature, diagnostic methods (questionnaires, tests, interviews, and surveys), observational methods (observation, introspection, and self-evaluation). Among the factors there is using of modern informational environment, but under the conditions when students‘ independent work is motivated and organized correctly by a teacher that has certain necessary skills. It has defined pedagogical conditions implementation of which in practice of training future teachers provides the desired result: the promotion of future teachers‘ professional cognitive interest, cultivating their valuable attitude to independent work as the main means of self-education and improvement, involving them to creative and search tasks with using information and communication technologies. Implementation of the above teaching conditions in the training of future teachers in the educational process of the National University of Pharmacy and Kharkiv State Academy of Physical Culture has showed that their use has ensured the growth of future teachers‘ skills to organize students individual work in the modern informational environment: in the experimental groups the number of future teachers with high level of skills has increased on average by 13. Determined pedagogical conditions of forming future teachers‘ skills to organize students‘ individual work in the modern informational environment have been effective enough. Recently the problem of "professional identity" has generated researchers‘ growing interest, because in the current social and economic conditions the requirements to a professional‘s personality and to the peculiarities of their training grow and constantly change. Theoretical overview of the concept of professional identity in psychological literature. Theoretical methods: analysis, synthesis, systematization, generalization, comparison. Professional identity has been studied by many scientists, among them there are E. But despite the number of studies, nowadays, there is no generally accepted and clear definition of professional identity. In general, it implies a set of certain characteristics which help to navigate in the world of professions, to realize personal professional potential. If we turn to the problem of the place of professional identity in a common identification space, we can see that there is no consensus among Ukrainian scientists. Pavlenko believes that professional identity is an integral part of personal identity. Pryazhnikov has different opinion, he argues that the formation of a professional identity contributes to the development of a person in whole, and it is as a fundamental impulse in this process. Many researchers believe that professional identity is a complex personal mechanism that consists of a set of professional constructs: 1) professional identity; 2) professional suitability; 3) development of professionally important qualities; 4) professional readiness; 5) professional development; 6) developing professional life plan. Generalizing the substantial characteristics, data definitions one can say that professional identity is a multifactorial phenomenon in which complex relationship of personal characteristics, the unity of professional identity, professional identity processes, and professional orientation is expressed. Educational proсess is complex and multifaceted phenomenon, with such components as education and upbringing. The objective of higher education is the formation of professional competence of future specialist and organization of the educational process in the high school. One of the most important educational procedures that contributes to the execution of educational objectives are methods of control and evaluation of students‘ educational achievements. Unlike the foreign language learning, where the main aim is developing foreign language skills, task of control and evaluation is to determine their level of development. The main purpose of control in the process of learning a foreign language is managing this process. Opening of the features of pedagogical control and determining the impact of traditional and innovative methods of controling the quality of students‘ assessment and their attitude to studying foreign language. The modern teacher can not remain indifferent to the quality of the work he did, (lecture or practical training) and the most important is, how did the students remember the lesson. The procedure of control should be an integral part of testing and personal experience of the teacher, the teaching methods and ability to effectively influence on forming of students‘ knowledge and skills, development of their creative abilities and their attitude to the education. For the decision of these questions, we used the theoretical and empirical methods. The theoretical are: the analysis of psycho-pedagogical and methodological sources, systematization, comparison and synthesis of scientific sources on the study with a view to the selection and interpretation of actual material. Empirical ones are: observation on the features of organization and conducting of the prosedure of different kinds of control and objectivity of assessment of students‘ knowledge, questionnaires) 389 Results and discussion. During learning the foreign language, it is effective to use such innovative techniques of controlling students‘ achievements in studying as: group work, test verification of knowledge and skills, problem-based learning, programmed control, using of printed basis exercise books, project work, didactic and role-playing games and using of mutual control and self-control tasks. These aspects cause the importance of further improvement of control methods and evaluation of knowledge and skills of future specialists, and adding the results of the learning process. During the learning this problem, it was found that the impact of students‘ achievement would be improved if the teacher focuses his professional work on the next aspects: using innovative methods and forms of control, improving the enabling of environment and emotional foreign language atmosphere for control tasks, involving students to active preparation and searching activities using personal-oriented, interactive and gaming technologies which influence on the improving level of foreign language. The intensification of the processes of European and global integration has led to the occurrence of higher educational institutions of Ukraine to the common European space. Because of this the topicality of psychological and pedagogical component during training in postgraduate study is obvious.

Batch no cheap 10mg vardenafil otc erectile dysfunction medication shots, Batch Size discount vardenafil 10 mg mastercard best erectile dysfunction drug review, and stage of manufacture along with signature of technical staff buy discount vardenafil 10mg on line erectile dysfunction medicine in pakistan. Do all the areas have their own independent air locks separately for men and material entry. What criteria of pressure differential has been set for production v/s adjoining areas. Whether records of line clearance is maintained according to appropriate checklist. Please specify detailed account of sanitation proramme specific to various areas, equipment. Whether all the containers of each batch of starting materials is sampled for identification test. How control on temperature and humidity conditions, wherever necessary, maintained in these storage areas. If by electronic data processing system then how access is controlled to enter, modify etc. Whether master formula and detailed operating procedures are maintained as hard copy. Which colour coding system is used to indicate the status of a product and equipment. How returned/unused packaging material like foils is controlled so as to prevent contamination and cross- contamination. Please provide list of reference standard and reference impurities procured from the authentic sources. Please specify the procedures of preparation of working standard from the reference standards. Whether approved specifications for different materials, products, reagents, solvents including test of identity content, purity and quality available. How it is ensured that the sample collected are representative of the whole batch. Whether specification of finished product include (a) the designated name of the product and the code reference; (b) the formula or a reference to the formula and the pharmacopoeial reference; (c) directions for sampling and testing or a reference to procedures; (d) a description of the dosage form and package details; (e) the qualitative and quantitative requirements, with the acceptance limits for release; (f) the storage conditions and precautions, where applicable, and (g) the shelf-life. Whether head of production, quality control and quality assurance unit endorse this documents. Mention shall be made of any substance that may „disappear‟ in the course of processing. Whether the Batch Processing Records for each product on the basis of currently approved master formula is being maintained. Whether periodic audits of distribution center are carried out to access warehousing practices Whether distribution records are part of the batch record. Whether validation studies of processing, testing and cleaning procedures are conducted as per pre defined protocol. How records and conclusion of such validation studies are prepared and maintained. Specify how significant changes to the manufacturing process equipments material etc are controlled. Whether reports of serious drugs reaction with comments and documents immediately sent to Licensing Authority Is there any criteria for action to be taken on the basis of nature of complaint / adverse reaction. If so, by which method: Bubble Point, Diffusive Flow or Pressure Hold Test Sterilization (Autoclaving) 10. Whether the design of 2 closures and containers suitable to make cleaning easy, and to make an air tight seal when fitted to the bottles 11. Whether the material 3 quality of the stoppers and closures ensures that it does not affect the quality of the product and avoids the risk of toxicity 11. In case the bottles are 4 not dried after washing are these rinsed with distilled water or pyrogen free water as the case may be as per written procedure 12. In case of vacuum cleaning how it is used to avoid 1 contamination and cross contamination. Whether the washing facility in the granulation suites 1 takes proper measures to prevent contamination and cross contamination. What type of dust control facilities are provided with the Tablet compressing machine in its cubicle. Whether coating area is provided with suitable exhaust system and environmental control (temperature, Humidity) measures. How printing operation is controlled to avoid mix up of 1 products during printing. Whether after printing, the products are approved by 2 quality control before release for packaging or sale 7 Packaging (Strip & Blister) 7. Whether in the manufacturing area walls, 2 floors and ceiling are impervious, non-shedding, non-cracking, coved at all junctions. Whether the doors and windows and light fixtures are flushed, made up of non fiber shedding material. If not how tanks are cleaned to prevent accumulation of residual microbial growth and cross- contamination. Pls specify whether the critical processes validated Prospectively, retrospectively or concurrently. Whether validation of following performed and documented: Analytical methods, Production and assay equipment, Sterile production processes, Non-sterile production processes, Cleaning procedures, Critical support systems (purified water, water for injections, air, vapor, etc. Please specify whether periodical challenge tests performed on the system to verify reliability. Is the validity of the critical processes and procedures established based on a validation study?