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Good Manufacturing Practice
This program was produced at customer request to address the training requirements of staff in mainstream human and animal GMP production, including medical devices, tablets, contact lenses, cosmetics and etc. Subjects include: Health and healthcare; 'GMP'; Premises and the environment; Ingredients and contaminants; The process; People; Summary.
DVD-ROM / 2009 / 25 minutes
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The program is designed to be used as early as the first day of employment, to provide an induction for everyone who will be required to understand and comply with GMP. The emphasis is placed heavily on 'if in doubt... ask!' Subjects include: Why working here is different; The principles of Good Manufacturing Practice; Control of the manufacturing process; Record keeping; The product and you; Summary.
DVD-ROM / 2009 / 27 minutes
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A comprehensive multimedia step-by-step training program for all who are involved in the manufacture of tablets.
Content includes:
General considerations
contamination control
personnel considerations
the production stages
review.
DVD-ROM / 2008 / 20 minutes
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This first ever professional multi-media program on the subject is a fully documented competency training course that provides a comprehensive introduction to cGMP from the engineering and maintenance perspective. Presented in 8 parts plus part-by-part Review section this complete course is designed both for training new personnel and re-training all engineering and maintenance staff who are subject to cGMP regulatory control.
DVD-ROM / 2005 / 36 minutes
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This new release is the latest of the new generation multi-media training products from MVI Training Presented in 7 parts plus part-by-part Review section. This complete course is a primer designed both for training new personnel and re-training all existing personnel who are subject to cGMP regulatory compliance and need to understand the implications of microbiology and its control.
DVD-ROM / 2004 / 32 minutes
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This fully documented multi-media training program provides a comprehensive introduction to cGMP and is presented in 10 parts plus review section. It is designed as a complete course for training new staff and re-training all who are subject to cGMP regulatory control including those working in laboratories, engineering and maintenance as well as operational and quality department staff.
DVD-ROM / 2003 / 42 minutes
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A complete nine-part training course on the requirements of GMP as it impacts on materials handling, warehousing and distribution.
Part 1 - An introduction to GMP;
Part 2 - What is logistics;
Part 3 - Facilities & personnel;
Part 4 - Documentation;
Part 5 - Labeling and marking;
Part 6 - Incoming goods;
Part 7 - Goods in store;
Part 8 - Shipping;
Part 9 - Review.
DVD-ROM / 2000 / 45 minutes
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A training and education program with brilliant graphics that completes an A to Z course on microfilters. Includes: introduction to microfilters; filter types, design & construction; filter process & operations; validation & integrity testing; review.
DVD-ROM / 2000 / 45 minutes
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A four-part module which addresses the training needs for both contractors and visitors who must be aware of, and comply with, the regulatory requirements of GMP while on site. Includes: Part 1 - An introduction to GMP and its importance; Part 2 - Contamination in the environment; Part 3 - GMP, people, personal hygiene and behavior; Part 4 - Review.
DVD-ROM / 1999 / 22 minutes
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This DVD provides an introduction and overview to non-specialists who will be exposed to various aspects of validation at both managerial and operator levels. Some of the areas covered: what is validation; why & when to validate; definitions; principles of validation; validation methods; validation plans & protocols. In addition, the DVD contains three case-studies.
DVD-ROM / 1998 / 38 minutes
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In the context of GMP, cleaning is as critical a process as any production activity. The need for it to be properly validated is now recognized and addressed by regulatory authorities as a central quality feature of contamination control. This DVD covers the following areas; validation in the context of cleaning; devising the cleaning strategy; residues & residue limits; cleaning validation protocol; surface sampling techniques.
DVD-ROM / 1998 / 28 minutes
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This module provides a comprehensive overview of all aspects of water, the most commonly used material in the manufacture of GMP compliant products. Sections include: where does water come from; the contaminants; organics, inorganics, particulate matter & microorganisms; the chemistry of water; purified water vs. water for injection; purification methods; pre-treatment, softening, reverse osmosis, de-ionization; filtration, UV light; water systems; microbiological control; storage & distribution; maintenance, cleaning & sterilization; validation.
DVD-ROM / 1998 / 32 minutes
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This DVD covers every aspect of the packaging of GMP compliant products and identifies how this area of production can be the cause of as many as 80% of all product recalls. Covering: why GMP packaging is different; labeling & product information; primary & secondary packaging; packaging materials; people & packaging; the packing process; documentation & records.
DVD-ROM / 1997 / 23 minutes
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Regulatory authorities focus on training in personal hygiene. This program provides a straightforward and objective look at why attention to personal hygiene is important and tactfully illustrates every aspect of the subject. It covers topics such as: the human hazards and hygiene; head-hair, nose, mouth, eyes, ears; makeup, cosmetics, and jewelry; the body and its danger areas; hands and contamination; personal health.
DVD-ROM / 1996 / 18 minutes.
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Regulatory authorities focus on training in personal hygiene. This program provides a straightforward and objective look at why attention to personal hygiene is important and tactfully illustrates every aspect of the subject. It covers topics such as: the human hazards and hygiene; head-hair, nose, mouth, eyes, ears; makeup, cosmetics, and jewelry; the body and its danger areas; hands and contamination; personal health.
DVD-ROM / 1995 / 18 minutes
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Content includes: The Place of Engineering & Maintenance; Facility Design; Engineering & Facility Maintenance; Engineering & Equipment Design; Maintenance. Includes interactive FDA and EU GMP regulations.
DVD-ROM / 32 minutes
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Content includes: Pharmaceutical packing; Assessing the risks; Doing the audit; Auditing the packaging supplier. Includes interactive FDA and EU GMP regulations.
DVD-ROM / 15 minutes
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Content includes: Auditing tableting & solids; Contamination control; Auditing each stage of production. Includes interactive FDA and EU GMP regulations.
DVD-ROM / 17 minutes
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Content includes: The Go Wrong Things of Dispensing; Separate, Clean & Decent; Dispensary Procedures. Includes interactive FDA and EU GMP regulations.
DVD-ROM / 13 minutes
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Content includes: An Audit Must Start Somewhere; Goods Reception Area; Sampling Area; The Building and Housekeeping; Organization; Special Requirements. Includes interactive FDA and EU GMP regulations.
DVD-ROM / 16 minutes
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Content includes: Making topical products; Starting the audit; Topicals manufacture; Filling & packaging. Includes interactive FDA and EU GMP regulations.
DVD-ROM / 19 minutes
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It may be easy to assume that isolators and other barrier technologies offer a fool-proof solution to controlling contamination when working on sensitive products or materials. There are however many elements that influence the success of working with such devices.
Isolators require careful attention from design to installation, operation and beyond for the rest of their life-cycle. Many factors play a part in the integrity of the unit including the background environment, operator behavior, material preparation and transfer, cleaning routines and maintenance.
This program provides a detailed grounding on the subject illustrating the benefits, pitfalls and the necessary controls to achieve consistent quality performance when using isolators.
What is an isolator?
Isolator applications & backgrounds
Isolator design and construction
Working at isolators
Materials transfer
Cleaning & sterilizing isolators
Validation
Maintenance programs
Review
DVD / 47 minutes
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