Workshops: Wednesday 30 July 2008
Please click on the links below to learn more:
- Workshop A: Practical Tips to Build a Cleaning Validation Program According to FDA/ICH Guidelines
- Workshop B: How To Perform Risk Assessment And Reap Maximum Benefit From It?
- Workshop C: How To Deal With OOS/OOT/OOC In Routine
- Workshop D: Overcoming GMP challenges concerning microbiological quality control and quality assurance
08:00 – 11:00 Workshop A: Practical Tips to Build a Cleaning Validation Program According to FDA/ICH Guidelines
This workshop will take you through the fundamentals of Cleaning Validation and its application to the pharmaceutical industry. Dr. Mithilesh Trivedi will highlight the different regulatory guidelines and the requirements of cleaning validation. Following which, the justification for set limits will be discussed with examples & real-life case studies.
Why Cleaning Validation?
- Regulatory Requirements
- Regulatory Guidelines
Cleaning Validation Protocol:
- Procedures
- Sampling points
- Difficult to clean area
- Sampling Methods (advantages & disadvantages for each method)
Analytical Methods:
- How do you check which analytical method fits your product
- Analytical methods with advantages & disadvantages
- How to set limits
Justification for Limits:
- Different calculation methods
- Examples of the calculations for set limits
Case Study & Discussion
Dr. Mithilesh Trivedi
Vice President – QA & QC
Calyx Chemicals & Pharmaceuticals Ltd
About Your Workshop Leader
Mithilesh Trivedi completed his Ph. D. from UDCT (presently known as UICT), Mumbai. He has over 25 years of extensive experience in the area of Research & Development, Quality Assurance & Quality Control, and Manufacturing & Operation in Chemical; Fine Chemical; Bulk Drugs and Formulation Industries. He also has extensive experience in product development, process optimization & control, standardizing production norms, chemical lab practices and supplier technical assurance. Mithilesh was also actively involved in analytical method validation and demonstrated excellence in managing training & development operations. His knowledge also lies in that of maintenance, calibration and troubleshooting of analytical equipment to enhance productivity. Lastly, Mithilesh has also experience in Sterility Pyrogen including BET (LAL Test) and Toxicity Testing and he ensured compliance of various quality measures by maintenance of appropriate requisite documentation/ records.
11:15 – 14:15 Workshop B: How To Perform Risk Assessment And Reap Maximum Benefit From It?
- Understanding of risk assessment and the tools used for it
- Practically performing risk assessment and FMEA of supplier/vendor, contract and self manufacturing in small groups
- Techniques on developing risk chart, defi ning level of control required to meet the AQL (acceptable quality limits) and plan (way forward) to minimise the risk
- Strategies to develop a validation or audit plan according to the level of risk
- Benefits of adopting a Risk-Based Approach for your business plan
Syed F. Huda
Quality Manager
RECKITT BENCKISER PAKISTAN
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Irfan Ali Zeb
Quality Assurance Manager
RECKITT BENCKISER PAKISTAN
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About Your Workshop Leaders
Mr. Syed F. Huda possesses diverse training/experience in manufacturing, QA/QC, regulatory, drug laws, product development, line extension, formulation development, process & method development, R&D, factory administration, operations, supply chain, process & method validation, plant design & maintenance, engineering projects, and risk management. He is an experienced GMP auditor and certified lead auditor for ISO 9001–2000.
Mr. Irfan Ali Zeb’s area of expertise is in adding value to the pharmaceutical manufacturing and quality in meeting international quality standards. He has been trained on manufacturing and Quality Assurance of various dosage forms from leading pharmaceutical plants in Japan. Mr. Irfan has been associated with leading multinational and national companies in the areas of Process Validation, Facilities & Equipment Qualification, Inspections, GMP training, documentation and compliance and is a certified ISO 9001 Lead Auditor.
Choose Workshop C or D
14:30 – 17:30 Workshop C: How To Deal With OOS/OOT/OOC In Routine
- Understanding the implications of legislation in the EU and US on your business
- Key definitions of OOS/OOT/OOC and how they are applied in your products
- Two strategies to resolve OOS issues for timely product launches
- Outlining the statistical background of OOS/OOT/OOC
- Highlights of successful case scenarios and pitfalls to avoid
About your Workshop Leader
Dr. Klaus is the Head of Quality Assurance or QC and Qualified Person in accordance with the EU GMP Guide of PAA Laboratories GmbH, Linz. He was also the project manager of validation, QA/QC in LSMW GmbH, Stuttgart in the year 2002-2004. As a manager, Head of Quality Control-Coagulation; Coagulation Testing – Laboratories, Immunological and Serological – Laboratory, Pharmacological – Laboratory, Standard and Reagents Laboratory, Method Development Laboratory in Baxter AG, Vienna, Dr. Klaus was responsible for release testing of all plasma products, standards and reagents and method development and negotiations with authorities such as PEI, BIFA, NIBSC and FDA.
Dr. Klaus Pittertschatscher
Head of Quality Assurance Corporate Q.P.
PAA Laboratories
OR
14:30 – 17:30 Workshop D: Overcoming GMP Challenges Concerning Microbiological Quality Control And Quality Assurance
The aim of an evaluation in case of a deviation is to provide a risk analysis which enables the quality assurance unit or the qualified person responsible for the product to make a final decision with respect to batch disposition. Based on several practical examples, Christine will be discussing ways of efficient investigation and evaluation of microbiological deviations in the pharmaceutical environment with you in this unique round table session which includes interactive exercises. Come with your most pressing questions and Christine will take you through the following:
- Root cause analysis: Where to look to find the root cause? Which are possible root causes based on the microorganism found?
- Risk assessment: Which data needs to be considered when investigating a microbiological deviation?
- Batch release: Is the quality of the product compromised? What information is important for the decision on batch disposition?
Christine Magin
Manager Quality
KWIZDA PHARMA GESMBH
About Your Workshop Leader
From 2002 to 2007, Christine was a manager at Baxter bioscience in Vienna, Austria, and was responsible for microbiological quality control of production processes and monitoring of production environments and critical systems for the validation of microbiological test methods. She was also responsibility for sterility assurance and microbiological process validation there. As a manager at KWIZDA Pharma Vienna, Austria, Christine’s responsibility lies in quality control and quality assurance for the two plants in Vienna, Austria and Linz, Austria. Since 2006, Christine has been notified as Qualified Person according to EU-GMP for drugs for human use to the Austrian Ministry of Health.
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