PHARMA KNOWLEDGE MANAGEMENT is an institution built on knowledge as we believe“KNOWLEDGE IS POWER”. Knowledge is required at every level for an individual to grow from one level to a higher level. When people grow means that the company is growing.
In todays jet age, although every professional wants to upgrade their skills, there is no time for learning, as every individual company has to achieve their monthly & annual set targets. Keeping this in mind PHARMA
KNOWLEDGE MANAGEMENT has designed FAST TRACK COURSES for pharma professionals in Tech Ops.
PHARMA KNOWLEDGE MANAGEMENT offers “ESSENTIAL PROGRAM IN TECHNICAL & OPERATIONAL MANAGEMENT” a new series of fast track Certificate programs.
Certificate Course in Quality Management
Day 1
9.00-9.30 am | Understanding The Need For Quality Systems and Quality Culture |
9.30-10.30 am | Good Documentation Practice |
10.30-11.00 am | Tea Break |
11.00-12.30 am | Qualification of Vendors for Suppliers of APIs andPackaging Materials , Techno Commercial Agreements |
12.30-1.30 pm | Lunch Break |
1.30-2.30 pm | Cross Contamination – Sources and Prevention |
2.30-3.30 pm | Fundamentals of Microbiology |
3.30-3.45 pm | Tea Break |
3.45- 5.15 pm | Case Study and Discussions |
Day 2
9.00-10.00 am | Management of Change Controls |
10.00-10.45 am | Market Complaints |
10.45-11.00 am | Tea Break |
11.00-12.00 am | Requirements of Batch Recalls |
12.00-12.45 pm | Basics of ICH Q8 |
12.45-1.30 pm | Lunch Break |
1.30-2.30 pm | Basics of ICH Q10. |
2.30-3.30 pm | Case Study |
3.30-3.45 pm | Tea Break |
3.30-4.00 pm | Discussions on Case Study |
4.00- 5.30 pm | Evaluation of Day 1 & Day 2 |
Day 3
9.00-11.00 am | ICH Q7 and ICH Q 9 |
11.00-11-15 am | Tea Break |
11.15-12.15 am | Equipment Qualification |
12.15-1.30 pm | Validation –Process, Cleaning and Analytical |
1.30-2.00 pm | Lunch Break |
2.00-3.15 pm | Management of Failure Investigation and Deviations Reporting |
3.15-3.30 pm | Tea Break |
3.30- 4.45 pm | Case Study |
4.45-5.30 pm | Evaluation |
Course Details
• During this course, participants will learn Theoretical Aspects as well as industry knowledge.
• Hands on Training to evaluate how well one can apply this knowledge gained into their present job skills.
Faculty Profile
PERVIZ MENESSE
Perviz has been involved for almost 40 years in the field of Quality Operations with then Hoechst, now Sanofi, where she retired as Associate Director – Industrial Quality & Compliance- International Sourcing. Her main areas of expertise lie in Quality Operations, Quality Assurance, Auditing (Formulation Plants and API Plants ), GMP and Microbiology.
She continues to be actively associated with the Pharmaceutical Industry, particularly in the field of Quality and independently operates as an Auditor, Trainer & Consultant in all areas of Quality Operations. Perviz is a Certified Auditor and possesses extensive experience & expertise of having audited over 200 pharma units, including Solid & liquid orals, all forms of Injectibles -SVP, LVP and Dry Powder, and Lyophilised products, as well as Active Pharmaceuticals Ingredients (APIs) including Sterile APIs.
Perviz is also well-versed with Regulatory requirements of ICH Q7A, Q8, Q9,Q10, EU GMP, US GMP, as well as local Schedule M. She possesses full knowledge of site transfer activities and has participated as Team Leader for transfer of 2 sterile injectibles from USA to India for a WHO project. Perviz also has extensive experience and is currently actively involved in Training in the field of Quality Management Systems, with particular focus on GMP requirements, Microbiology, Good Documentation Practices, Good Warehousing Practices, Cross Contamination Controls, Vendor Management, Qualifications and Validations,among a range of other topics.
DR. ANANTH V. PRABHU
Dr. Ananth V. Prabhu has a doctorate from University of Kansas and has completed Post Doctorate Work in Organic Chemistry from Georgia Institute of Technology. He is an approved FDA Chemist for Instrumental Analysis, Chemical analysis, Microbiological and Sterility Testing. Dr. Prabhu has valuable exposure and experience in many aspects of Pharma Manufacturing and Research, Quality and Regulatory Affairs, be it in the MNC culture as well as in Indian companies. After a long stint in Glaxo India, where he has contributed in various positions, he has also served with various leading Pharma companies in key positions, Kopran Limited, Abbott India Limited, the latest being Arch Pharmalabs as Chief Scientific Officer. In addition, Dr. Prabhu is a member of the Working Committee of the Indian Pharmacopoeia and has helped write the new
Schedule M of 2003. He has many research publications to his credit. Dr. Prabhu is involved with professional as well as Pharmaceutical education with Bombay College of Pharmacy, SNDT and Mangalore Universities. He has delivered popular lectures on GMP, Quality Assurance, etc. for various industry bodies, FDA Maharashtra, Indian Pharmaceutical Association and to various Pharma companies in India.
For every level of information that we take, knowledge would be the greatest thing that we can have on any particular issue of concerns. Knowledge is even consider part of growing.