Pharma Product Design, Technology & Commercial Manufacturing
What you'll learn
- This course will help students to learn about pharmaceutical products, development, keys in potent product manufacturing, technology transfer, analytial and manufacturing process validation and stability study requirements. This course will help students to learn product design concept and manufacturing with life cycle approach.
Requirements
- The person who is interested in learning should learn in focussed way to understand the concepts and practical approach.
Description
This course will take you to understand about how product is designed, product transfer & validation aspects before commercialisation. After commercialisation further it will focus on how stability study is performed.
First of all, we need to learn about product development as per the ICH guideline - ICH Q8. This will explain us about how to design the pharmaceutical products and also how quality by design concept to be followed. After this, main step is about technology transfer in the pharmaceuticals. This technology transfer will focus on transfer of analytial technology as well as manufacturing process technology in the manufacturing unit. Once technology is transferred, the first commerical batches manufactured should be studied in detailed as per the process validation requirements. Furthermore, it is important to note that, there is special care to be taken in case of manufacturing of potent molecules. So, a separate lecture on manufacturing of potent molecules is available in this course.
This is still not enough for pharmaceutical products. After process validation, the process validation batches should be subjected for stability study. Furthermore, long term stability study will be continuted for every year. Overall this training session will be very much helpful for all pharmaceutical professionals for learning from design the product to commercialisation.
Who this course is for:
- Pharmacy students, Pharmaceutical professionals, consultants etc. This course is essential for auditors, quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers
Instructor
- 4.0 Instructor Rating
- 792 Reviews
- 3,303 Students
- 22 Courses
A Quality-oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance.
The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include Quality Compliance, Supplier Audit, building systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation, and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post-approval queries raised by regulatory agencies, etc.
·Independently handled - Quality assurance and Quality Control department for more than 13 years.
· Audits faced- USFDA (7 times), ANVISA, MHRA, MCC, TGA, IDMA excellence, WHO audit, EU regulatory (8 times), Yemen MOH, Digemid (Peru), Russian Authority audit, etc.
· Analytical Background: The analytical background includes, physical, chemical, and microbiological testing of raw material, finished product, and stability samples. Handled the chromatographic instruments – HPLC, GC, IR, UV-visible spectrophotometer, AAS, etc.
· Technical support-
o cGMP and data integrity gap audit.
o Support in facing regulatory audits & compliance report review
o Support in product development and/or regulatory submission or evaluation of readymade dossiers which can be used after site transfer for commercial manufacturing.
· Expertise in GXP Computerised systems-
o Major Software handled - Lab solution software, Empower 3 software, LIMS, TRIMS & Track wise
o Provide technical support to process owner during Computer system validation, Review of Computerised system validation documents for compliance, auditing the computer system supplier, performing GAP audit of Computerised systems, Evaluation of Computerised systems with respect to cGXP compliance, data integrity controls and ease of operating pragmatic approach
· During tenure audited more than 500 vendors/suppliers and trained more than 5000 candidates. I am an approved Auditor by the multinationals I worked and also I am a CQI-IRCA Certified QMS/Lead Auditor as per ISO9001:2015).