Physical Pharmaceutics-I

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physical pharmaceutics 2019 question paper BP302T Pt BD Sharma University, Rohtak HR PCI

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B PHARAM 6TH SEM PHARAMACEUTICAL QUALITY ASSURANCE COMPLAINT Reasons Types of Complaint Steps involved in Handling of complaints Product Complaint Data Sheet Complaint Record Regulatory Guidelines SOP on Complaint Handling RECALL Reasons Types of Recall Recall Classification Levels of Recall How to Recall the Product? How To Notify The Consumers? Regulatory Guidelines SOP on Product Recall DRUG RECALL IN 2013 AND 2014

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b pharma 6th sem pharmaceutical biotechnology Protein engineering Objectives of protein engineering Rationale of protein engineering Protein engineering methods Rational design -site-directed mutagenesis methods Advantages and disadvantages of rational design Directed evolution -random mutagenesis Advantages and disadvantages of directed evolution Peptidomimetics Classification of peptidomimetics Advantages and disadvantages of peptidomimetics Flow cytometry Instrumentation Principle components

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BIOSENSOR, PHARMACEUTICAL BIOTECHNOLOGY, B PHARAM, 6TH SEM Basic components of Biosensor Working of Biosensor Types of Biosensor Electrochemical biosensor Optical biosensor Thermal biosensor Resonant biosensor Ion-sensitive biosensor Applications of Biosensor Nano sensors sensing device Father of the Biosensor components of BIOSENSOR BASIC PRINCIPLE OF BIOSENSOR BIO-ELEMENT TRANSDUCER DETECTOR RESPONSE FROM BIO-ELEMENT IDEAL BIOSENSOR BASIC CHARACTERESTICS

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genetic engineering, principles, b pharma 6th sem, biotechnology What is a gene ? Definition History Process Molecular tools of genetic engineering Restriction enzymes History of restriction enzyme Mechanism of action Types of restriction enzymes Application of restriction enzymes Blunt ends Sticky ends transgenic cisgenic. knockout organism. Host organism vector TRANSGENIC PLANTS DOLLY THE SHIP TRANSGENIC ANIMALS

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ICH GUIDELINES, ICH, INTERNATIONAL CONFERENCE ON HARMONIZATION, B PHARMA 6TH SEM, PHARMACEUTICAL QUALITY ASSURANCE ICH and ICH guidelines Need Origin of ICH Evolution of ICH ICH members Steps of ICH STEP 1: Building Scientific Consensus STEP 2: Agreeing on Draft Text STEP 3: Consulting Regional Regulatory Agencies STEP 4: Adopting Harmonized Guidelines STEP 5: Implementing Guidelines in ICH Regions Categories of ICH guidelines

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Good manufacturing practices, GMP, pharmaceutical quality assurance, 6th sem , b pharam Introduction Why GMP? Evolution of GMP Main risks without GMP Principles of GMP Design and construct the facilities and equipment properly Follow written procedures and Instructions Document work Validate work Monitor facilities and equipment Write step by step operating procedures and work on instructions Design ,develop and demonstrate job competence Protect against contamination Control components and product related processes Conduct planned and periodic audits GMP categories

Good manufacturing practices himanshu

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quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem Quality management in the drug industry Why quality is important in pharmaceuticals? Impacts of ignorance on quality Quality control Role of quality control in pharmaceutical industry Objectives of quality control Components of quality control Functions of qc in pharmaceutical industry Quality assurance Total quality management Characteristics of tqm Benefits of tqm:

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The global implications of DORA and NIS 2 Directive are significant, extending beyond the European Union. Amongst others, the webinar covers: • DORA and its Implications • Nis 2 Directive and its Implications • How to leverage directive and regulation as a marketing tool and competitive advantage • How to use new compliance framework to request additional budget Presenters: Christophe Mazzola - Senior Cyber Governance Consultant Armed with endless Excel files, a meme catalog worthy of the best X'os (formerly twittos), and a risk register to make your favorite risk manager jealous, I swapped my computer scientist cape a few years ago for that of a (cyber) threat hunter with the honorary title of CISO. Ah, and I am also a quadruple senior certified ISO27001/2/5, Pas mal non ? C'est francais. Malcolm Xavier Malcolm Xavier has been working in the Digital Industry for over 18 Years now. He has worked with Global Clients in South Africa, United States and United Kingdom. He has achieved Many Professional Certifications Like CISSP, Google Cloud Practitioner, TOGAF, Azure Cloud, ITIL v3 etc. His core competencies include IT strategy, cybersecurity, IT infrastructure management, data center migration and consolidation, data protection and compliance, risk management and governance, and IS program development and management. Date: April 25, 2024 Tags: Information Security, Digital Operational Resilience Act (DORA) ------------------------------------------------------------------------------- Find out more about ISO training and certification services Training: Digital Operational Resilience Act (DORA) - EN | PECB NIS 2 Directive - EN | PECB Webinars: https://pecb.com/webinars Article: https://pecb.com/article Whitepaper: https://pecb.com/whitepaper ------------------------------------------------------------------------------- For more information about PECB: Website: https://pecb.com/ LinkedIn: https://www.linkedin.com/company/pecb/ Facebook: https://www.facebook.com/PECBInternational/ Slideshare: http://www.slideshare.net/PECBCERTIFICATION

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Physical Pharmaceutics-I

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