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GAMP 5 System Lifecycle: From Concept to Retirement

GAMP 5 System Lifecycle: From Concept to Retirement

Concept Phase — Understanding the Need The lifecycle starts with identifying why the system is needed and how it will support a GxP process. Key activities: Project Planning & Specification … Read More

Global Product Development | Key Steps and Common Mistakes

Multiple Peak Plasma Concentrations (Cmax) of Drugs

Oral Medication with Food versus When Fasted

Cleaning Validation | FDA vs EMA

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One Product Development for Multiple Markets

Common Deficiencies in ANDA Submissions for Peptide Drugs

Critical Material Attributes (CMAs) of Excipients

Key Considerations for Generic Formulation Development

Oral Vs Parenteral Dosage Form | Formulation Challenges

Pharmacy Exam

Saudi Pharmacist Licensure Examination (SPLE) Syllabus

KAPS Exam Syllabus

Knowledge Assessment of Pharmaceutical Sciences (KAPS) Exam

Saudi Pharmacist Licensure Examination (SPLE)

Disease Management

Osteoarthritis Management Guidelines

COPD Management Guidelines

Diabetes Management Guidelines

Obesity Management Guidelines

Drug Digest

Prednisolone | Drug Digest

LYRICA (Pregabalin) | Drug Digest

ACCUTANE (Isotretinoin) | Drug Digest

Metformin Tablets | Drug Digest

academia

‣All About Kidneys

‣Why Protein Folding Matters?

‣DNA Extraction Process

‣What Makes a Protein Functional?

‣Citric Acid Cycle: A Journey Into Cellular Metabolism

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basic Pharmacy

‣Physicochemical Properties of Drugs

‣Three Systems of Measurement Used in Pharmacy

‣Unit of Measurement in Pharmacy Practices

‣How to Increase Solubility of Drug?

‣Introduction to Drug Discovery

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clinical Pharmacy

‣Oral Medication with Food versus When Fasted

‣Differential Binding of Drug to Plasma Proteins and Tissue Proteins

‣Why Vape Laced with Etomidate is Dangerous?

‣Alfentanil Interaction with Rifampin

‣Factors Affecting on Clearance of Apixaban

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industrial Pharmacy

‣Global Product Development | Key Steps and Common Mistakes

‣Multiple Peak Plasma Concentrations (Cmax) of Drugs

‣Cleaning Validation | FDA vs EMA

‣Why is Testing into Compliance Prohibited?

‣Understanding the Inactive Ingredient Guide (IIG)

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audit & inspection

‣Anatomy of an FDA Inspection | Part 2 of 2

‣Anatomy of an FDA Inspection | Part 1 of 2

‣US FDA Inspection and SMEs Role

‣Essential Skills for Pharma Auditors in Today’s Regulatory Landscape

‣Audits and Inspections in Pharmaceutical Industries | Similarities and Differences

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automation

‣GAMP 5 System Lifecycle: From Concept to Retirement

‣FDA Guidance: Computer Software Assurance

‣Validation of ERP System

‣Difference Between Industry 1.0, 2.0, 3.0 and 4.0

‣Re-Validation in Computerized System Validation (CSV)

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DATA INTEGRITY

‣Why is Testing into Compliance Prohibited?

‣Microbiological Data Integrity Issues and Control Strategies

‣Data Integrity in Pharmaceutical Industry

‣Data Integrity in Analytical Laboratories

‣Objective of Data Management and Integrity in Pharmaceutical Industry

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pharma guidelines

‣Best Practices for Managing Suppliers of API Manufacturers | APIC Guidance

‣Comprehensive List of Pharmaceutical Guidelines

‣Facility Readiness Goal Date Decisions Under GDUFA

‣Explanation of FDA Designations

‣EU and US GMPs | Understanding the Similarities and Differences

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