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Introduction to Aseptic Behaviour and Practices In Injectable Manufacturing Operations

Description

The course explains the genesis and meaning of the word “Aseptic” and then the meaning of commonly used but inadequately understood two words namely “behaviour” & practices”. This makes the understanding of the topic much easy, simple and clearer. In the concluding part of the course, you will understand why the Aseptic Behaviour and Practices are so critical when it come to manufacturing of sterile products in general and Injectable products in particular.

What will you learn

In this course, you will understand the meaning of Aseptic Behaviour and Practices, very basic but important understanding of what approach, skills & capabilities you need to work in GMP compliant manner.

Language: English

How to Download Course certificate: Watch Video

Topics for this course

5 Lessons27m 41s

Aseptic Behaviour and Practices

Introduction00:03:45
Part 1 – What is Aseptic?00:08:32
Part 2 – Understanding Behaviour00:05:08
Part 3 – What are Practices?00:07:46
Part 4 – Conclusion00:02:30
Quiz: Aseptic Behaviour and Practices

About the instructor

Mr. Rajendra Tamboli is having 36 plus years of experience in Formulations Manufacturing Operations. He is a Subject Matter Expert in Sterile Products & Oral Solid Dosage Forms. His body of work ranges from management of Manufacturing Operations, QMS & GMP, SME – STERILE PRODUCTS & OSD to Training, coaching, mentoring the employees to impart, develop, improve and sustain the technical knowledge. He is a firm believer in imparting knowledge, Training, coaching, hand holding of employees can transform the way employees think, behave, work and deliver results in to meet organisation’s needs and expectations of the regulatory agencies. He has served as Director - Technical Training, Subject Matter Expert and Special Trainer – Sterile Products & OSD at Dr. Reddy’s and is currently the Project Head -Technical trainings at PharmaState Academy. PROFESSIONAL SYNOPSIS Organisations and positions of responsibilities as: • M/s. Sandoz India/Novartis India – 12 yrs. – Injectables and OSD (In House and Contract Manufacturing.) • M/s Astra IDL/Astra-Zeneca India - 8 years Injectables, OSD, L.O, Ointment & Gels and Aerosols, • Domestic organisations Like M/s. Medreich, Panacea Biotec, Associated Capsules Pvt Ltd, Dr. Reddys Laboratories – Total 16 yrs. - Injectables, OSD, L.O, Ointment & Gels and oral Dry Powders. Acquired Hands on Experience in managing the Manufacturing operations of Diverse range of Dosage Forms: Sterile- parenteral and ophthalmic (Aseptic +TS) products, Anticancer Products (Lyophilised Vials &Isolator Technology), Topical Gels (sterile & Non-Sterile), OSD (Tablets, HGC, SGC, DRY POWDERS) and Liquid Orals.
5.00 (10 ratings)

3 Courses

271 students

599

Material Includes

  • 5 Learning Videos
  • 1 Quiz
  • Course Certificate

Enrolment validity: 30 days

Target Audience

  • Operators
  • Mechanics
  • Housekeeping Staff
  • QA & QC Personnel
  • Supervisors & Line managers
  • Others involved or associated with manufacturing operations of sterile products.

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