How to find a job with GMP skills

1. How to audit GMP systems

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Audits is one of the best tools to learn and understand the process and the quality system of any company. For this reason, internal audits to your company and audits to the pharmaceutical raw material suppliers are usually performed to ensure the quality of the supplied product and therefore to ensure the quality of the final medicinal product. Initial and continuous professional training for auditors is of utmost importance for the correct performance and take advantage of the audits. Therefore, I have developed this course to give you a detailed overview about important matters to consider and to be aware when performing audits to GMP systemsWhat you will learn:· General information (GMP history, Regulatory requirements, audit types, etc)· Who should be audited, risk-based approach· Audit process· Audit plan and audit team· Auditor skills and technical knowledge requirements· Categorisation of audit findings· Auditing API suppliers· Different behaviors from the auditees and how to handle them· Other related topics as remote auditsMoreover, during the course I will handle many examples and supportive documentation for your knowledge. What will you receive when enrolling into the course?· Lifetime access to the course and future updates· Personalized support and answer to all your questions and doubts· Certificate in "How to audit GMP suppliers" from Udemy - which you can include on your resume· Money-back guarantee in the first 30 days - if you don't like the course you can request a 100% refund of your investmentSo, at the end of this course you will have the knowledge to perform audits to GMP suppliers. See you on the course!...

2. Basic Good Manufacturing Practices (GMP)

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The compliance with GMP (Good Manufacturing Practices) standards is the decisive aspect for the production of high quality products. They are mandatory for all Pharmaceutical laboratories, thus health authorities performs inspection and audits in order to check the compliance. So, all employees must be aware and follow them all the time. What you will learn during the course: During this course, you will learn from the beginning the concepts that every employee from the pharmaceutical industry must know and comply with.  Moreover, I will present the most important elements of a pharmaceutical system, the appropriate behaviors that must be followed and I will give details of the fundamental parts of the pharmaceutical industry. What will you receive when enrolling into the course?· Lifetime access to the course and future updates· Personalized support and answer to all your questions and doubts· Certificate in "Basic Good Manufacturing Practices" from Udemy - which you can include on your resume· Money-back guarantee in the first 30 days - if you don't like the course you can request a 100% refund of your investment· I will handle  supportive documentation for your knowledge and questionnaires for practiceSo, at the end of this course you will have the basic knowledge of GMP'sSee you on the course!...

3. GMP: Tablet Manufacturing Technology Industry Certification

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Drug manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others. *Complete the course as per your free time as life time access is available. If you are paying more than 5k INR or $15 for private institute/academy then you are in loss. Please compare the course description and amount you are paying for such course. The design and manufacture of pharmaceutical tablets is a complex multi-stage process whereby formulation scientists ensure that the correct amount of drug substance in the right form is delivered at the appropriate time, at the proper rate and in the desired location with its chemical integrity protected to that point. Most drug substances do not possess the required properties which give satisfactory flow from the hopper to the die cavity of tablet presses. As a result, they are subjected to pre-treatment either alone or in combination with suitable excipients to form free-flowing granules that lend themselves to tabletting. A tablet is a pharmaceutical oral dosage form (Oral Solid Dosage, or OSD) or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients. Tablets are prepared either by molding or by compression. Tablets are commonly manufactured by wet granulation, dry granulation or direct compression. These methods may be considered to consist of a series of steps (unit processes) - weighing, milling, mixing, granulation, drying, compaction, (frequently) coating and packaging. Unit Operations in tablet manufacturing Numerous unit processes are involved in making tablets, including Particle size reduction and sizing, Blending, Granulation, Drying, Compaction, and (frequently) Coating. Various factors associated with these processes can seriously affect content uniformity, bioavailability, or stability. Primary goals of tablet manufacturing processThe primary goals include: To formulate tablets that are strong and hard to withstand mechanical shock encountered during manufacturing, packing, shipping, dispensing and use. To formulate tablets that are uniform in weight and in drug content. To formulate tablets that are bioavailable according to indication requirements. To formulate tablets that are chemically and physically stable over a long period of time. To formulate tablets that have elegant product identity which is free from any tablet defects. Factors that influence the choice of manufacturing process used during tablet formulationIn general, the choice of formulation process employed during tablet manufacture is dependent upon such factors as: Compression properties of the Active Pharmaceutical Ingredient (API)/ drug substance. Physical and chemical stability of the API during the manufacturing process. Particle size of the formulation ingredients. Availability of the necessary processing equipment. Cost of the manufacturing/formulation process. Personnel requirements during manufacture of pharmaceutical tabletsProduction pharmacists/ supervisorsManufacturing chemistAnalytical chemistQuality assurance managerMachine operatorsMechanicsIn addition to the job-specific responsibilities of these personnel, all manufacturing employees must be versed and trained in Current Good Manufacturing Practices (CGMPs) and in the appropriate Standard Operating Procedures (SOPs) governing their area. Area required for manufacture of tabletsRaw material warehouseReceiving quarantineApproved raw material sectionDispensaryProduction roomMixing, Granulation and Drying SectionTablet Punching SectionCoating SectionQuality control sectionPackaging Section. QUALITY CONTROL EQUIPMENTSFriabilatorDisintegration apparatusHardness TesterVernier CaliperIn This Course Students will learn above pharmaceutical aspects/approach for tablet manufacturing in GMP Area. Students-Diploma in pharmacyB. PharmacyM. PharmacyM. Sc StudentsFreshers & Employees Students seeking oportunitirs for Pharma job careerLook for course discription, Look for See you in the class......

4. Good Distribution Practices (GDP-GMP)

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The compliance with GDPs (Good Distribution Practices) standards is the decisive aspect to maintain the high quality and integrity of the medicinal products though the entire supply chain to the patient. Good Manufacturing Practices applies during the production of medicines, while Good Distribution Practices comes into play when the product is shipped from the production site until the patient. Applicable to transport companies, warehouses, distributors, brokers, etc. They are mandatory for all wholesale distributors, thus all employees must be aware of them and comply with the requirements. What you will learn during the course: During this course, you will learn from the beginning the concepts that every employee from the pharmaceutical distribution industry must know and comply with.  Moreover, I will present the most important elements of a pharmaceutical distribution company, as the main departments and processes involved. At the end of this training you will be able to understand the importance of the GDPs and the requirements which will help you improve your daily work, use it in a job interview or in a future position in the distribution of medicines sector. What will you receive when enrolling into the course?· Lifetime access to the course and future updates· Personalized support and answer to all your questions and doubts· Certificate in "Good Distribution Practices" from Udemy - which you can include on your resume· Money-back guarantee in the first 30 days - if you don't like the course you can request a 100% refund of your investment· I will handle supportive documentation for your knowledge and questionnaires for practiceSo, at the end of this course you will have the knowledge of GDP'sSee you on the course!...

5. Good Manufacturing Practices (GMP) Certification Course

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Good Manufacturing Practice or GMP is a set of quality assurance practices promoted by regulatory authorities (including the WHO and US FDA) to ensure manufacturing processes are rigorously set and monitored. This training is designed to help you implement into an organization the increasing legislation and guidance on goods within the manufacturing industry. GMP compliance is widely-accepted as the best way to conduct business, putting product quality first. The course is aimed principally at personnel occupying supervisory and management roles who need detailed explanation of GMP, requirements of GMP and how it works. The GMP course will also be of benefit anyone in the manufacturing (including food, food packaging and food packaging manufacturing) and pharmaceutical industries who have had no significant GMP training previously. At the end of this course, you will be able to review general and specific requirements for documentation and records, review the way in which a self-inspection programs should be carried out, discuss aspects of good practices in production and quality control. You will understand the roles and duties of key personnel and departments in GMP implementation (i. e. production and quality personnel), and the importance of personnel training to GMP. You will learn best practices in complaints and recalls handling, self-inspection and quality audits. You will learn and be able to apply key considerations for GMP audit...

6. Quality in Pharmaceutical Industry (GMP & GLP & GHP)

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Good Manufacturing Practices (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Quality Management (QM) is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management (QM) therefore incorporates Good Manufacturing Practice (GMP). Good Laboratory Practices (GLP) define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc. Good Hygiene Practice (GHP) is to include, upkeep of the facilities, pest control, waste control, use of protective clothing, cleaning and sanitization of equipment including maintenance, and the selection and use of chemicals etc. COURSE AGENDA1 INTRODUCTION 2 GENERAL DEFINITIONS 2 1 GENERAL DEFINITIONS-I 2 1 1 DRUG PRODUCT (PHARMACEUTICAL PRODUCT) 2 1 2 ACTIVE PHARMACEUTICAL INGREDIENT (API) 2 1 3 STARTING MATERIAL 2 1 4 INTERMEDIATE PRODUCT 2 1 5 PACKAGING MATERIAL 2 1 6 BULK PRODUCT 2 1 7 FINISHED PHARMACEUTICAL PRODUCT (FPP) 2 1 8 MANUFACTURING FLOW CHART 2 2 GENERAL DEFINITIONS-II 2 2 1 PRODUCTION 2 2 2 PACKAGING 2 2 3 MANUFACTURE (MANUFACTURING) 2 2 4 MANUFACTURER 2 2 5 MARKETING AUTHORIZATION (PRODUCT LICENCE) (REGISTRATION CERTIFICATE) 2 2 6 QUALITY ASSURANCE 2 2 7 QUALITY CONTROL 2 2 8 IN-PROCESS CONTROL 2 3 GENERAL DEFINITIONS-III 2 3 1 STANDART OPERATING PROCEDURE (SOP) 2 3 2 BATCH (LOT) 2 3 3 BATCH NUMBER (LOT NUMBER) 2 3 4 BATCH RECORD 2 3 5 MASTER RECORD 2 3 6 MASTER FORMULA 2 3 7 SPECIFICATION 2 3 8 AUTHORIZED PERSON 2 4 GENERAL DEFINITIONS-IV 2 4 1 CLEAN AREA 2 4 2 CONTAMINATION 2 4 3 CROSS CONTAMINATION 2 4 4 HVAC (HEATING, VENTILATION AND AIR CONDITIONING) 2 4 5 AIRLOCK 2 4 6 AIRLOCK TYPES (PERSONNEL & MATERIAL) 2 4 7 AIRLOCK TYPES (PRESSURE MOVEMENT) 2 5 GENERAL DEFINITIONS-V 2 5 1 CALIBRATION 2 5 2 QUALIFICATION 2 5 3 TYPES OF QUALIFICATION 2 5 4 VALIDATION 2 5 5 TYPES OF VALIDATION 3 PHARMACEUTICAL QUALITY SYSTEM 3 1 QUALITY MANAGEMENT 3 2 ROLES OF PHARMACEUTICAL QUALITY SYSTEM 3 3 GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 3 3 1 GOOD MANUFACTURING PRACTICE (GMP) 3 3 2 BASIC REQUIREMENTS OF GMP 3 4 QUALITY CONTROL 3 4 1 QUALITY CONTROL 3 4 2 BASIC REQUIREMENTS OF QUALITY CONTROL 3 5 PRODUCT QUALITY REVIEW 3 5 1 PRODUCT QUALITY REVIEW 3 5 2 BASIC REQUIREMENTS OF PRODUCT QUALITY REVIEW 4 PERSONNEL 4 1 PERSONNEL 4 1 1 PERSONNEL 4 1 2 QUALIFICATION & PRACTICAL EXPERIENCE 4 1 3 ORGANIZATIONAL CHART 4 1 4 QUALIFICATION & RESPONSIBILITIES 4 1 5 JOB DESCRIPTION & RESPONSIBILITIES 4 2 KEY PERSONNEL 4 2 1 KEY MANAGEMENT PERSONNEL 4 2 2 RESPONSIBILITIES OF THE HEAD OF PRODUCTION DEPARTMENT 4 2 3 RESPONSIBILITIES OF THE HEAD OF QUALITY CONTROL DEPARTMENT 4 3 TRAINING 4 3 1 PERSONNEL TRAINING 4 3 2 BASIC TRAINING AND NEWLY RECRUITED PERSONNEL TRAINING 4 3 3 TRAINING FOR PERSONNEL WORKING IN HAZARDOUS AREAS 4 3 4 TRAINING FOR VISITORS OR UNTRAINED PERSONNEL 4 4 PERSONNEL HYGIENE 4 4 1 PERSONNEL HYGIENE 4 4 2 PERSONNEL HYGIENE PROCEDURES 4 4 3 PERIODIC MEDICAL EXAMINATION 4 4 4 PROTECTIVE GARMENTS 4 4 5 PROHIBITIONS IN GMP AREA 5 PREMISES AND EQUIPMENT 5 1 PREMISES-GENERAL 5 1 1 PREMISES AND EQUIPMENT 5 2 PREMISES-PRODUCTION AREA 5 2 1 FACILTY DESIGN FOR MINIMISING OF CROSS CONTAMINATION IN PRODUCTION AREA 5 2 2 QUALITY RISK MANAGEMENT FOR PREMISES AND EQUIPMENT PLACED IN PRODUCTION AREA 5 2 3 INTERIOR SURFACE REQUIREMENTS IN PRODUCTION AREA 5 2 4 HVAC DESIGN AND LIGHT FITTINGS IN PRODUCTION AREA 5 2 5 DRAINAGES IN PRODUCTION AREA 5 2 6 WEIGHING AREA IN PRODUCTION DEPARTMENT 5 2 7 CLEANING IN-PROCESS CONTROL IN PRODUCTION AREA 5 3 PREMISES-STORAGE AREA 5 3 1 STORAGE AREAS 5 3 2 CONDITIONS OF STORAGE AREAS 5 3 3 QUARANTINE STATUS OF STORAGE AREAS 5 3 4 SEGREGATED AREAS FOR REJECTED, RECALLED OR RETURNED AREAS 5 4 PREMISES-QUALITY CONTROL AREAS 5 5 EQUIPMENTS 5 5 1 EQUIPMENT 5 5 2 CLEANING OF EQUIPMENT 6 DOCUMENTATION 6 1 DOCUMENTATION 6 2 SPECIFICATIONS 6 2 1 SPECIFICATIONS 6 2 2 SPECIFICATIONS FOR STARTING AND PACKAGING MATERIALS 6 2 3 SPECIFICATIONS FOR FINISHED PRODUCTS 6 3 MANUFACTURING FORMULA 6 4 PROCESSING INSTRUCTIONS 7 PRODUCTION 7 1 PRODUCTION 7 2 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION 7 2 1 PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION 7 2 2 TECHNICAL MEASURES FOR CROSS-CONTAMINATION IN PRODUCTION 7 2 3 ORGANISATIONAL MEASURES FOR CROSS-CONTAMINATION IN PRODUCTION 7 3 STARTING MATERIALS 7 4 PROCESSING OPERATIONS 7 4 1 PROCESSING OPERATIONS: INTERMEDIATE AND BULK PRODUCT 7 4 2 PROCESSING OPERATIONS: FINISHED PRODUCT 8 QUALITY CONTROL 8 1 QUALITY CONTROL 8 1 1 QUALITY CONTROL 8 1 2 RESPONSIBILITIES OF QUALITY CONTROL 8 1 3 FINISHED PRODUCT ASSESMENT 8 2 GOOD LABORATORY PRACTICE 8 2 1 GOOD LABORATORY PRACTICE 8 2 2 GOOD LABORATORY PRACTICE: DOCUMENTATION 8 2 3 GOOD LABORATORY PRACTICE: SAMPLING 8 2 4 GOOD LABORATORY PRACTICE: TESTING 8 2 5 GOOD LABORATORY PRACTICE: STABILITY 9 COMPLAINTS, QUALITY DEFECTS AND PRODUCT RECALLS 9 1 PERSONNEL AND ORGANISATION 9 2 PROCEDURES FOR HANDLING AND INVESTIGATING COMPLAINTS 10 CONCLUSION...