VQI offers an array of courses covering different aspects of cGMP and GLP. Want to save time and money? VQI can conduct a customized version of any of these courses at your preferred location: Courses Offered (2008) Module #1: Methods Development, Validation Procedures and Conformity Assessment in the Analytical Laboratory Abstract: This course is designed with a fundamental grass roots approach to understanding measurement uncertainty and approaches validation in a very generic style.
method both from the Quality Systems perspectives and with the more fundamental approach of measurement, errors and uncertainties in the analytical measurement process in particular.
iterative and modular approach to understand validation in general at the same time establishing the capabilities of the analytical method as the method is being developed. The various stages of scoping out the method initially followed by an informed strategy of design, development and optimization to arrive at the validation parameters will be presented elaborately and lucidly.
be discussed.
presentation.
documentation and regulatory requirements for regulatory compliance issues. There is extensive guidance provided during the course for preparing validation protocols for various stages of IND, NDA and laboratory control, QA, QC inside companies. A brief discussion on statistical tools, SQC, SPC and stability indicating assays are included. Module #2: Qualification and Validation of Lab Systems and Validation in the Pharmaceutical Laboratory (IQ,OQ,PQ)
and validation of various instruments, apparatus, devices, systems and equipment from a risk assessment and product lifecycle perspective with several examples, specifications, protocols and SOP requirements at various stages of deployment and use of various equipment, instruments, etc. It scopes out the requirements testing and acceptance criteria to calibrate, standardize or validate as appropriate various laboratory equipment/plant/ process equipment/devices/gadgets/recorders/on line monitors/meters/micro devices (e.g. HPLC, GC, MS, Dissolution apparatus/blenders/mixers/stability chambers/autoclaves or common Instruments, meters and devices in plant, production micro labs, aseptic areas and processing departments throughout various functions in the cGMP facilities. Examples are discussed with acceptance criteria, particularly with lab systems and their QC/QA perspectives. The regulatory aspects and global guidelines will be discussed with documentation strategies, including PVP, validation protocols, SOP’s, charts, forms, data sheets, etc., with global guidelines discussions from a risk assessment (ICH Q9, ASTM, ISO) approach.
Biotech and Medical Device Industries Abstract: This course is an intermediate level course designed for Q.C. Management, Analytical, Production, Process Engineering, Maintenance Supervisors and other plant personnel engaged in the plant and production equipment. It will help to scope out the effectiveness of cleaning procedures in the various matrix of drug products in the streams of processing and manufacturing. It covers detailed treatment of residues, different techniques of sampling, and the applicable microbiological and analytical procedures used to support Cleaning Validation and their verification. A major focus in this presentation is to develop a risk assessment strategy for scoping out Cleaning Validation inside Pharmaceutical, Biotech and Device Companies.
Cleaning Validation Team is a key factor in the management of Cleaning Validation. The discussions will include effective training and documentation for a successful program. Module #4: Good Distribution Practices (GDP) & Directives: EU/WHO Abstract: This 2-day course will cover the various aspects of supply chain integrity as scoped out in the European GMPs and will provide a compre- hensive overview of Good Distribution Practice and the Quality Systems and procedures necessary to ensure compliance with the directive. Some of the issues related to the handling and global distribution of drug products, including the requirements and guidance from the EU, EMEA, WHO directives and other sources, will be discussed. Also, general preparedness, documentation, quality assurance, counterfeit concerns, and handling of emergency situations (FDA directives) on Product Recall will be addressed as well. Case studies and real-life examples on the vulnerability of supply chain will be included. Module #5: Process Analytical Technology (PAT) Abstract: This presentation will introduce some of the recent initiatives and directives from US FDA as well as the genesis, scope, relevance and applications of PAT framework. Some basic understanding of process measurement, process optimization and control, impact of micro sensors and online monitoring tools will be provided. Some examples of micro analytical techniques in process control and validation will be included.
framework of PAT implementation. Guidance from recent ICH Guidelines (ICH Q8, Q9, Q10, etc.) and other sources are included.
including NIR, Raman, Acoustics, GC, HPLC that are finding more and more applications in At line, On line measurements at various stages of production and processing.
applications in PAT and will be covered.
a challenge, and the discussions will include the dynamics related to such activities.
and Requirements in the Regulated Industries/Quality Systems Abstract: This highly informative two-day presentation will aim at outlining and highlighting the roles and responsibilities of the QP in medicinal products for the areas of manufacturing, holding, and distribution, with emphasis on legal obligations.
of product development will be discussed with relevance to the documentation strategies and other requirements.
Agreement and other relevant documents to satisfy the requirements. Comparison with WHO and other global standards will be included. . Module #7: Trends and Highlights of Global Compliance Issues - Risk Management Approach Abstract: This 2-day presentation will aim at providing highlights of current Regulatory Compliance issues with particular reference to US FDA, EMEA, WHO, Canadian GMP’s and other international guidelines. International harmonization initiatives, including the ICH, OECD, HAS, etc., will be discussed.
approach and preparation within a company with risk assessment and mitigation strategies will be discussed. Module #8: Study Director, QAU & Management: Roles and Responsibilities in the GLPs (FDA/OECD) Abstract: This 2-day presentation aims at highlighting the roles, responsibilities and duties of key Management, Supervisors, Scientists, Principal Investigators, Regulatory, QAU and other personnel in GLP facilities, contract laboratories, research institutes, CRO’s or other organizations engaged in the conduct of GLP (FDA, FIFRA, OECD, JAPAN, etc.) studies and other non-clinical studies related to drug development, safety & toxicity studies and various targeted evaluations. Discussions will include the various aspects of Study Conduct, QAU audits, Protocol development, and the roles of Study Directors, Management, PI’s, QAU and other key personnel with real life examples, case histories, group participations and class assignments. The basic tenets of FDA and OECD or other GLP’s will be covered with comparison on some key issues. The course is geared towards the development of understanding the basic requirements and key compliance issues with a Risk Assessment and QS based approach at various levels of Management and organization in a compliant GLP Testing Facility. Module #9: Pharmaceutical Development, Process Optimization and QA/QC Validation Issues Abstract: This two-day presentation will cover the various stages of pharmaceuticals product development with a major emphasis on the process development, optimization and validation issues. The framework of product development and guidances from the international standards on CGMP, ICH Q7, Q8 with a risk-based approach (ICH Q9 ) will be discussed.
discussed. The development of Protocols and Product Development Reports will be included. Case studies and group exercises will be included. Module #10: Integration of ICH Directives for cGMP [under construction] Module #11: QA/QC & Validation Issues in the Water Analysis Laboratory Abstract: This two-day short course will address some of the QC/QA related activities in laboratories engaged in various testing and analysis of water compliance to AWWA, EPA, USP and other domestic and international regulatory standards. Development and validation of analytical, microbiological and other test procedures requirements will be included.
work of a high thruput laboratory will be discussed. The various analytical methods and other test procedures routinely run in the water analysis laboratories and their validation requirements will be discussed with select examples. The significance of various validation parameters, including accuracy, precision, robustness, reproducibility, LOD, LOQ, etc., will be discussed. The documentation strategies for regulatory compliance to various standards will be discussed.
systems, their scoping out and focus. The feedback from CAPA to support the Quality Management in manufacturing, production and CRO operations will be discussed with examples. The investigations of OOS/OOT results and customer complaints vis-à-vis of other sources will be discussed with the examples of various quality tools, including Root Cause Analysis and Pareto charts with a comprehensive risk assessment and quality systems based approach in GMP/GLP facilities, CRO’s, and other organizations. Examples of Deviations, FDA 483’s and Warning Letters will be included. CAPA plays a major role in the Quality Systems implementation with a risk- based approach. The discussions will cover aspects of Risk Assessment and Quality Systems with excerpts and guidance from ICH Q9, ICH Q10, ISO 73 and other global standards.
The documentation strategies, and the dynamics of input and interactions between the various functions in a company, will be included in the discussions. Examples and case studies will be included with group interactions.
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Contact Us Dr. Shib Mookherjea ValQual International 3959 Pemberly Pines Circle Saint Cloud, FL 34769 or ValQual International P.O. Box 170 Florham Park, NJ 07932 Phone: 201-615-6346 Fax: 407-498-2027 email: info@valqualintl.com Administrative Manager Wendi Petrone Fax: 864-963-7899 email: wpetrone@valqualintl.com |
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