Pharma Knowledge Management – Certificate Program In Quality Control

6th Sep. to 8th Sep.

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 Program In Quality Control

Day 1 – Thursday 6th September 2012

1. Introduction to Quality Control Activities
2. Sampling of materials: Regulatory / GMP approach
2.1 Raw material, Packing materials, in-process/ intermediates samples, semi-finished, finished
and packed products
2.1 Raw material, Packing materials, in-process/ intermediates Sampling of recovered / recycled
solvents

3. Sampling of materials: Regulatory / GMP approach

4. Control / Retention Sample Management: Regulatory guidelines

5. Validation and calibration of Quality control equipments used for testing of different dosage forms. Glassware calibration

6. Standardization / “use before” terminology of volumetric solutions, reagents and indicators

3. Interactive session / clarification regarding any of the QC related activities

Day 2 – Friday 7th September 2012

1. Stability testing programme
2. Out of specification – QC laboratory investigation
3. Sampling of sterile Raw Materials
1. Case study
2. Evaluation

Day 3 – Saturday 8th September 2012

1. Glimpses Into The World Of Microbiology
2. Fundamentals of Microbiology
3. Knowing and Understanding-Controlling and Killing Microbes
4. Microbiological Aspects of Clean Room Behaviour
5. Microbial Limit Tests
Analysis and Validation Aspects
6. Sterility Testing
Method Validation and Failure Investigations
7. Environmental Monitoring
Aspects of Viable Counts Monitoring
8. Water System
     Qualification/Validation
Auditing Water Systems

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.

VAIDYANATHAN

Dr. Vaidyanathan who has an overall experience of about 40 years in Pharmaceutical industry has been working in various capacities with national and multinational Pharmaceutical companies. The organization he has worked for includes Roussel (India) Ltd., German Remedies, Kopran and AMRI (India) Pvt. Ltd. He obtained his Doctorate from UDCT (Mumbai University) in the year 1973.
He is very conversant with regulatory guidelines and has been responsible in implementing Quality systems in the organization he has been working. During his tenure he has faced many audits from Regulatory Bodies viz. MCC, MHRA, TGA and EDQM.
Presently he is associated with few Pharmaceutical companies as advisor for Quality related activities.