QA

1. writing a validation-protocol what we need to know.
2. How to Write Validation Master Plan.
3. Validation, A Vital Cornerstone of Pharmaceutical Success.
4. Writing Effective SOPs in Pharmaceuticals
5. Revalidation of pharmaceutical processes.
6. Standard Operating Procedure SOP for Sampling in Process Validation.
7. Possible Causes of Out of Specifications in Pharmaceutical industry.
8. FDA training requirements for the pharmaceutical industry.
9. Tips to Develop Equipment Cleaning Procedure in Pharmaceuticals.
10. Gap Analysis for Regulatory Compliance in the Pharmaceutical Industry.
11. Quality Inspection in Pharmaceuticals: Ensuring Product Safety and Efficacy
12. Data Integrity: Definition, Its Main Categories, Usage, and How It Is Regulated in the Pharma Sector
13. What is Computer System Validation, Its Types, Importance, and Requirements in the Pharmaceutical Industry
14. Change Control in the Pharmaceutical Industry and Types of Changes
15. Steps in change control Process
16. Challenges For Change Control Implementation In Pharmaceutical Industry
17. Best Practices for Effective Change Control In Pharmaceutical Industry
18. Difference Between Concurrent, Prospective, and Retrospective Validation
19. Concurrent Validation in Pharmaceutical Manufacturing: A Comprehensive Overview
20. Retrospective Validation for Pharmaceutical Manufacturing: An Overview
21. Prospective Validation in Pharmaceutical Manufacturing: An In-Depth Guide
22. Corrective and Preventive Actions in Pharmaceutical Manufacturing
23. Comprehensive Guide for Pharmaceutical Sample Types for Manufacturing Applications
24. Sampling in Pharmaceutical Manufacturing: Safety, Strategy, and Best Practices
25. Types of Sampling Apparatus for Pharmaceuticals
26. Best Practices for Sampling Pharmaceutical Products: Ensuring Quality and Compliance
27. Acceptable Quality Level (AQL) sampling through its implementation and understanding.
28. 30 Common Ways to Avoid the Most Frequent GMP Errors
29. Types of Purified Water Systems in Pharmaceuticals
30. Top 5 Tips for a FDA Inspection Temperature and Humidity Validation/Mapping in Storage Area
31. Recovery Factor Determination in Cleaning Validation
32. Cleaning Validation of Pharmaceutical Equipment
33. Why Firms Must Avoid FDA 483 and Warning Letters?
34. What Does Quality Really Mean for Pharmaceuticals?
35. Quality System in Pharmaceuticals
36. Fault Tree Analysis for Investigation
37. 5 Why Tool for Root Cause Analysis in Pharmaceuticals ALCOA and ALCOA Plus
38. Principles for Data Integrity
39. Organogram and Job Responsibilities in Pharmaceuticals
40. CAPA and Its Proper Implementation
41. How Pharmaceutical Companies Can Prevent Drug Recalls
42. FDA Warning Letters for Cleaning Validation
43. Trends in GMP Violations in Pharmaceuticals
44. Guidelines for Drug Master File Submission
45. Tips for a Successful FDA Inspection in Pharmaceuticals
46. Risk Assessment for the Purified Water System in Pharmaceuticals
47. 4 Steps to Effective Change Control in Pharmaceuticals Contamination
48. Control Strategies for Manufacturing Area
49. New Drug Application (NDA)
50. Cleaning Validation of Clean-in-Place (CIP)
51. Systems Enhancing Efficiency and Quality:
52. Implementing Lean Manufacturing Principles in Pharmaceutical Manufacturing
53. Implementation of Six Sigma in the Pharmaceutical Industry
54. Quality Management System (QMS)
55. Criteria to Choose the Correct Swab for Cleaning Validation
56. Transport Validation for Pharmaceutical Products
57. 5 Challenges Facing Pharmaceutical Warehousing
58. Different Types of Deviations in Pharmaceuticals
59. Procedure for Process Validation in Pharmaceuticals
60. Purpose of Process Validation in Pharmaceuticals
61. Hold Time Study in Pharmaceutical Manufacturing
62. A Brief Description of the Entire Audit Process in Pharmaceuticals
63. Sampling in Cleaning Validation in Pharmaceutical Industry
64. Components of GMP :
65. GMP in Detail GMP Requirements in Pharmaceuticals Preparing for FDA Inspections:
66. Best Practices for Compliance Out of Specification Investigation in Pharmaceuticals
67. Importance of Cleaning Validation in Pharmaceutical Manufacturing
68. Steps to Ensure CAPA Success in Pharmaceuticals
69. Investigational New Drug (IND) Application
70. Pharmaceutical Compliance and Product Quality
71. What you should Inspect when Conducting Self-inspection in Pharmaceuticals
72. Good Distribution Practices for Pharmaceutical Products
73. Spillage Management in Pharmaceutical Production Area
74. What is the Best Career Option after B.Pharmacy?
75. Visual Inspection and Role of Artificial Intelligence in Pharmaceuticals
76. Pharmaceutical Product Failure and Its Remedies Human Error:
77. Some Fresh Approaches to Consider Non-conformance in Pharmaceuticals and Ways to Prevent it
78. Common Causes of Low Quality in Pharmaceuticals Tips for Preventing and Troubleshooting
79. Manufacturing Deviations Requirements for Good Documentation Practice (GDP)
80. Preparation of Batch Packaging Record (BPR)
81. Difference between Process Validation and Product Validation
82. Preparation of Master Formula Record (MFR)
83. Site Acceptance Test (SAT) Fluidized Bed Dryers and FInger Bags
84. Validation of Compressed Air Why Companies are Selling Same Drug in Different Prices?
85. Cleaning Validation Sample Protocol
86. Difference among Calibration, Validation & Qualification
87. Handling of Out of Calibration
88. Instruments and Equipment Periodic Review and Compliance in the Pharmaceutical Industry
89. Self Inspection and Its Implementation in Pharmaceuticals
90. Fishbone Tool of Investigation in Pharmaceuticals
91. 4 Tips to Reduce 483 Observations
92. Annual Product Quality Review (APQR/APR/PQR) in Quality Improvements
93. Self Inspection and Quality Audits Preparation of Annual Product Review (APR)
94. Guidelines for Preparation of Site Master File (SMF)
95. Total Quality Management (TQM) Importance of Qualified Persons in Pharmaceuticals
96. Regulatory Requirements for Market Complaints Code of Federal Regulations (CFR) Requirements and Implementation of Continuous Training in Pharmaceuticals
97. Quality by Design (QbD) in Pharmaceuticals SOP for Good Documentation Practices (GDP)
98. SOP for Bubble Point Test
99. Checklist for BMR Review
100. Checklist for Batch Review in Liquid Manufacturing
101. Checklist for Internal Audit or Self Inspection
102. Defects and Regulatory Compliance GMP Audit
103. Check List- Storage of Starting Materials
104. Checklist for OOS Investigation
105. Checklist for Vendor Audits GMP Audit
106. Check List- Personnel and Premises GMP Audit
107. Check List- Water Supply System GMP Audit
108. Check List- Weighing and Dispensing GMP Audit
109. Check List- Filling and Packaging GMP Audit
110. Check List- Process Validation GMP Audit
111. Check List- Sanitation and Hygiene GMP Audit
112. Check List- Equipment SOP for Personnel Gowning
113. Qualification SOP for Equipment Qualification
114. SOP for Failure Investigation
115. SOP for Validation of Visual Checking Inspectors
116. SOP for Training of Employees
117. SOP for Data Integrity
118. SOP for Self Inspection and Internal Audits
119. SOP for Documentation and Data Control
120. SOP for Password Policy and Data Backup and Storage for Computer Systems
121. SOP for Acceptable Quality Level (AQL)
122. SOP for Dossier
123. SOP for Reprocessing and Reworking
124. SOP for Deviation Control
125. SOP for Review of BMR
126. SOP for Mix-up
127. SOP for Product Recall
128. SOP for Process Validation
129. SOP for Change Control
130. SOP for Line Clearance
131. SOP for Authorized Signatory
132. SOP for Corrective Action and Preventive Action (CAPA)
133. SOP for Technology Transfer
134. SOP for Vendor Audit
135. SOP for Handling of Market Complaints
136. SOP for Gowning Procedure for Visitors in Quality Control
137. SOP for Collection and Storage of Retained Samples of Raw Material
138. SOP for Preparation, Approval, Issue, Control, Uncontrol and Revision of Quality Manual
139. SOP for Handling of Market Complaints in Pharmaceuticals
140. SOP for Release of Finished Product
141. SOP for Control of Master Data Generation by Computer System
142. SOP of SOP (SOP on SOP) in Pharmaceuticals
143. SOP for Hand Wash Procedure
144. SOP for Preparation, Review and Approval of Standard Operating Procedures
145. SOP for Challenge Test of Solid Flow Monitor in Fluid Bed Dryer
146. SOP on Standard Operating Procedure
147. SOP for Qualification of Facility/Equipments/Systems
148. SOP for Preparation of Master Formula Record (MFR)
149. SOP for Out of Specification (OOS) for Pharmaceutical Results
150. SOP for Incident Reporting and Investigation
151. SOP for Discipline in Manufacturing Area
152. SOP for Leak Test of Strip, Blister and Alu – Alu Blister Sealing
153. SOP for Line Clearance in Manufacturing Area
154. SOP for Destruction of Control Samples (Raw Material and Finished Product)
155. SOP for Trend Analysis
156. SOP for Sampling and Release of Inprocess Samples
157. SOP for Sampling of Finished Product Role of RH and Temperature in Dry Powder Injection
158. Manufacturing Importance of Corrective and Preventive Action (CAPA)
159. Handling Static Charge in Pharmaceutical Manufacturing Common
160. Technical Document (CTD) for Dossiers Role of Regulatory Affairs in Pharmaceuticals
161. Causes and Remedies of Picking in Tablet Manufacturing
162. Control of Contamination at Different Manufacturing Stages
163. Quality Manual and Quality Policy
164. Difference between Generic and Branded Medicines
165. Quality Metrics for Pharmaceutical Manufacturing
166. Best Communication Skills for Managers
167. Different Types of Glass Containers used in Pharmaceuticals
168. Visual Inspection of Light Sensitive Products
169. Difference between Recall and Mock Recall
170. How Does Quality Cost Less in Long Term?
171. Difference Between Disinfectants and Antiseptics
172. Causes and Remedies of Chipping in Tablet Manufacturing
173. Vendor Qualification/ Approval Flowchart
174. Electronic Batch Records in Pharmaceuticals
175. Types of Primary Packaging in Pharmaceuticals
176. Packaging of Pharmaceutical Products
177. Difference between cGMP and GMP
178. Causes and Remedies of Sticking in Tablet Manufacturing
179. Sustained Release and Prolonged Release Tablets and their Difference
180. Causes and Remedies of Cracking in Tablet Manufacturing
181. Causes and Remedies of Lamination in Tablet Manufacturing
182. Interview Questions for Quality Control / Assurance in Pharmaceuticals
183. Causes and Remedies of Capping in Tablet Manufacturing
184. Leak Detection of Colored Vials in Pharmaceuticals
185. IPQC During Compression
186. Operation Difference between Quality Assurance and Quality Control
187. Functions of Quality Assurance
188. Types and Functionality of Tablet Coating
189. In-process Quality Control Procedure
190. OOS Investigation Flowchart
191. Acceptable Quality Level (AQL) in Pharmaceuticals
192. Different Mesh Sizes and Mesh to Micron
193. Conversion Quality Risk Management in Pharmaceuticals
194. Importance of Mixing Time in Blend
195. Uniformity Difference between Humidity and Relative Humidity
196. Preparation of Batch Manufacturing Record (BMR)
197. Risk of TSE and BSE in Pharmaceutical Products
198. Preservatives and Their Concentrations used in Liquid Preparations
199. Binder Concentration in Tablet Manufacturing
200. SOP for Product Registration
201. SOP for Entry in Quality Assurance Department
202. Sampling and Testing in Exhibit and Process Validation
203. Batches Deviation Flowchart
204. Pass boxes in Classified Areas
205. Design of a Sterile Facility in Pharmaceuticals
206. Process Validation Sample Protocol
207. Difference between Incidence and Deviation
208. Three Consecutive Batches for Validation in Pharmaceuticals
209. SOP for Control of Cross-contamination
210. Guidelines for Preparation of VMP (Validation Master Plan)
211. Concept of Revalidation in Pharmaceuticals
212. Non-sterile Process Validation in Pharmaceuticals
213. Corrective Action and Preventive Action (CAPA)
214. Cleaning Validation of Manufacturing Equipment Change Control in Pharmaceuticals
215. Tablet Manufacturing Process Flowchart
216. Qualification of Systems and Equipment in Pharmaceuticals
217. Cleaning Validation Protocol for Pharmaceuticals
218. Prospective Validation
219. Prevention of Cross – Contamination During Processing Adverse Reaction of Pharmaceutical Dosages Forms Tablet Coating Problems and their Solutions in Pharmaceuticals Sugar Coating Process and its Problems in Pharmaceuticals
220. Product Recall Procedure in Pharmaceuticals
221. Procedure for Line Clearance Before Commencing any Manufacturing Operation
222. SOP for Quality Risk Management Hold Time Study of Cleaned Equipments
223. GMP Inspection in Production Procedure for Preparation of APR (Annual Product Review)
224. Facility Qualification in Pharmaceuticals.