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Format: Live Virtual/ Face-to-Face

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Learning Objectives:

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• ​​Dive deep into the nuances of pharmaceutical manufacturing regulations focused on the USFDA’s 21 CFR 210 & 211.

• Complete breakdown from the general provisions to records and reports.

• Insights into the control of components, packaging, labeling, and more.

• Practical understandings of the regulations.

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Course Outline:

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• This course covers majorly:

  • Overview of 21 CFR Part 210 & 211

  • Subpart A – General Provisions

  • Subpart B – Organization and Personnel

  • Subpart C – Buildings and Facilities

  • Subpart D – Equipment

  • Subpart E – Control of Components and Drug Product Containers and Closures

  • Subpart F – Production and Process Controls

  • Subpart G – Packaging and Labeling Control

  • Subpart H – Holding and Distribution

  • Subpart I – Laboratory Controls

  • Subpart J – Records and Reports

  • Subpart K – Returned and Salvaged Drug Products

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• Highly interactive and practical learning with case studies & group activities

• Post test to assess the attendees’ learning at the end of the course

• Issuance of training completion certificate to attendees (with Shaarkview and Customer’s management signatures).

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• At the end of the course, students can be able to have a decent understanding on requirements of Current GMP for Finished Pharmaceuticals: 21 CFR 210 & 211. 

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Who Should Attend:

• All stakeholders involve in cGMP activities in pharmaceutical product manufacturing as per 21 CFR 210 & 211.

• QA, QC, Production, Engineering, Warehouse & Others.

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Course Duration:  8 hours 

 

Training Days: 

• Live Virtual program: (One of the following options)

  • 1- Saturday / 1- Sunday, 09.00 to 18.00 Hr 

  • 1- Weekday (Mon/Tue/Wed/Thu/Fri), 09.00 to 18.00 Hr  

  • 2- Weekdays (Mon/Tue/Wed/Thu/Fri), 18.00 to 22.00 Hr 

• Face-to-Face program:​

  • 1- Weekday (Mon/Tue/Wed/Thu/Fri), 09.00 to 18.00 Hr 

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Language of Instruction: English​

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​​Instructor: Seetharam Kandarpa

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For Organization specific training class / other queries: 

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