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Pharmaceutical Manufacturing
Autoclaves are used primarily to sterilize finished medicines that are sealed in their final containers and media and equipment used in microbiological laboratories, as well as a variety of things used in aseptic manufacture.
This program examines the science involved in achieving sterility and some of the pitfalls that await unwary users of autoclaves.
Content includes: About autoclaves; The science of killing microorganisms; Air and temperature; Porous loads; Laboratory science - Biological indicators.
Complete with full documentation - transcript, glossary of terms, printable multiple choice knowledge test, presentation summary sheets and editable QuestionMaster quiz software.
DVD-ROM / 2010 / 22 minutes
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Autoclaves are used primarily to sterilize finished medicines that are sealed in their final containers and media and equipment used in microbiological laboratories, as well as a variety of things used in aseptic manufacture.
This second program on steam sterilization examines the practice of autoclave use - the working of the whole sterilization process.
Content includes: The sterilization elements; Validation principles; Sterility assurance; Determining loading patterns and cycles; Validation specifics; Re-qualification of autoclave processes.
Complete with full documentation - transcript, glossary of terms, printable multiple choice knowledge test, presentation summary sheets and editable QuestionMaster quiz software.
DVD-ROM / 2010 / 24 minutes
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Scientists have come a long, long way since Alexander Fleming's discovery of penicillin, the wonder drug of the 20th century. This program explains the function of infection -fighting antibiotics; vaccinations and insulin, crucial to the prevention of diseases such as smallpox and the management of diabetes; recombinant drugs, treatments involving genetically engineered DNA; and stem cells, those chameleon -like building blocks of the body. Commentary is provided by Drs. James Baker, Brian Athey, and Elliott Hill, of the University of Michigan; Susanne Kleff, of MBI International; and Bob Forgey, of ProNAI Therapeutics.
DVD / 2009 / 20 minutes
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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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By Michael Enright, Venkat Subramanian, Jeroen van den Berg
Following a successful IPO in April 2004, Biocon - India's foremost biotech company - is in the midst of an ambitious overhaul. Long dependent on revenues from the production of enzymes and generic drugs, the Company feels competitive pressures from within the country, as well as from other developing economies such as China. The Volume shows how the company's founder, Kiran Mazumdar-Shaw, intends to take the company to the next level by transforming Biocon from a producer of generics into India's first true innovator in the field of biotechnology.
DVD (With Business Case Booklet) / 2007 / 28 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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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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It's extremely important to understand basic cleaning and sanitizing procedures and to use these procedures when cleaning equipment used in a food or pharmaceutical manufacturing process. Lack of proper sanitation can cause increased returns of products, shorter shelf life, less profit, and can invite the threat of possible operation shutdown. Good sanitation does not cost, it pays.
This program will not address the entire cleaning and sanitation process because there are many facets, including Pest Control, Purchasing Sanitizers, Proper Storage of raw materials, and many others. This program will concentrate on cleaning and sanitizing of process equipment
Topics included in this safety video are: personal protective equipment (bump caps, rubber boots, gloves, safety glasses, face shields, hearing protection, and wet weather clothing), Material Safety Data Sheets (MSDS), Lockout/Tagout, the cleaning process - removing guards, dry waste disposal, cleaning, sanitizing, pest control, 5 steps that should take place when cleaning an area, sanitizers, halogens (chlorine, iodine, and bromine), Phenols, and Quaternary Ammonium Compounds.
DVD / 11 minutes
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Michael T. Rupp, PhD, RPh
Discussion on the status of recent initiatives to create a national standard for the routine documentation and transmission of clinical and billing information related to the delivery of pharmaceutical care between pharmacy providers and third-parties.
DVD / 90 minutes
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Where does GMP begin in R & D? How does GMP in R & D, differ to GMP as it applies to the manufacture of medicinal products for sale? The rationale of documentation as a means of providing a system of information and control. Process controls. Contamination control. Explanation of the terms Validation and Qualification.
DVD / 28 minutes
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Part 1 GCLP and its contribution to GMP. Importance of complying with Standard Operating Procedures and Methods of Analysis. Consequences of non-compliance. Dealing with samples. Equipment:- calibration, SOPs, checking before and after use. Reference standards and working standards.
Part 2 Record keeping. Analytical tests and assessment. Basic rules for compliance. Analytical reports. Standards for hand written data. Signatures. Computer generated documentation. Security procedures. Storage of laboratory records.
Part 3 Safety in a laboratory. Safe handling of laboratory waste. Accidents:- handling glassware, spillages, burns, fumes, etc. Good house-keeping. Responsibility to others. Personal hygiene. COSHH regulations. Reporting of potential hazards.
DVD / 35 minutes
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DVD
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DVD
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The concept of GMP in an R & D environment. The difference between producing medicinal products for sale and producing development products for clinical trials. Regulatory Authorities and site inspections. Documentation in R & D, its significance and purpose. Contamination control. Cleaning and cleaning validation. How clean is 'clean'? The principles of Validation and Qualification.
DVD / 24 minutes
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For operators working on packaging lines.
Personal hygiene. Line clearance procedures. Avoiding mix-ups. Packaging instructions. On-line checks and controls. Importance of following validated procedures. Documentation. Rules for handwritten data. Signatures. Reconciliation.
DVD / 16 minutes
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The differences between packaging medicinal products for clinical trials and packaging medicinal products for sale. Operating procedures. Cleaning. Potential sources of contamination. Documentation. Consequences of failure to work to GMP. What else can go wrong?
DVD / 32 minutes
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Walter J. Curran, Jr., MD; David S. Ettinger, MD; Chandra P. Belani, MD; Dawn Moose, MD
Integration of Chemotherapy and Radiation for Non-Small Cell Lung Cancer; New Drugs in Treatment of NSCLC; Recent Improvements in the Management of NSCLC; Management of Anorexia and Cachexia for Patients w/ NSCLC
DVD / 90 minutes
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The potential consequences of distributing a contaminated product. Common sources of product contamination. Methods of detecting the presence of contamination. A basic introduction to microbiology. Personal hygiene and protective clothing. The importance of good housekeeping.
DVD / 20 minutes
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Checking each delivery of raw materials. What to look for. Storage conditions. The risk of 'adulteration'. Process water as a potential source of contamination. Environmental and particulate contamination. Cross-contamination.
DVD / 20 minutes
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Design of equipment and facilities in order to keep contamination under control. Importance of following validated cleaning and sanitising procedures. Using approved materials. Importance of drying equipment after cleaning. Potential harm in allowing water to stagnate in vessels and equipment. Protection of equipment after cleaning. Documentation. The impact of maintenance work in relation to pharmaceutical hygiene. Cleaning floors. Sanitising drains.
DVD / 20 minutes
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Suitable as an induction programme for granulation operators.
Why granulate? Equipment used for granulation. Basic principles of granulation. How granulation is achieved. Problems that can arise during the granulation process. The effect of problems during granulation at the compression stage.
DVD / 19 minutes
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For all personnel on site who need to fully understand the importance of a Regulatory Inspection.
It is vital that a Regulatory Inspection runs smoothly and to this end much will depend on the co-operation of all personnel who may be involved. They need to understand who the Inspectors are and the reason for an investigation on site.
The video gives some practical advice (in terms of do's and don'ts) and underlines the importance of being in compliance at all times.
DVD / 28 minutes
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Similar to version 1 above - modified to reflect the same messages for personnel employed in the manufacture of active pharmaceutical ingredients (APIs).
DVD / 25 minutes
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Designed for personnel in R & D and Biotech activities.
DVD
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For maintenance personnel who work in pharmaceutical manufacturing areas, including instrument mechanics.
Examples of good and bad practices. Personal hygiene and protective clothing. The risk of contamination and cross-contamination. Record keeping and rules for handwritten data. The importance of following laid down procedures (SOPs).
DVD / 15 minutes
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For newly qualified and experienced tabletting operators.
This video refers to the rotary tabletting press and examines the most common types of tablet imperfections which occur at the compression stage, i.e. binding, sticking, capping, laminating, chipping and cracking. It discusses the likely causes and what (if anything) the operator can do to rectify the situation. It also refers to adverse conditions at the granulation stage, which may also be the cause and therefore outside the operator's control.
DVD / 21 minutes
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For production employees of medical device companies who may be unfamiliar with the concept of Current Good Manufacturing Practice (cGMP).
The aim of this presentation is to define the meaning of QUALITY, regardless of the enormous diversity of products classified as Medical Devices.
The presentation takes account of regulatory guidelines ISO 13485 and 21 CFR 820.
DVD / 20 minutes
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Narrated by AMY GOODMAN, host of Democracy Now!
Big Bucks, Big Pharma pulls back the curtain on the advertising tactics of the multi-billion dollar pharmaceutical industry to expose how it uses, manipulates, and sometimes creates illness in the pursuit of profit. With the help of health professionals and media scholars, the film dissects some of the most striking pharmaceutical ads on television, in the end revealing how the industry exploits people's emotions to promote the use of prescription drugs.
Review
"Anyone who ever prescribes or takes a pill should see this documentary." - ALEX SUGERMAN-BROZAN| Director, Prescription Access Litigation Project
DVD (With English Subtitles) / 2006 / 45 minutes
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Suitable for the induction of all personnel involved in the manufacture, packaging and storage of toiletries and cosmetics.
Written and produced in collaboration with members of the CTPA GMP Sub-committee. Emphasises the need for quality systems to meet customer expectations. Storage conditions. Bulk manufacture. Packaging. On-line tests and controls. Personal hygiene. Contamination and contamination control.
DVD / 20 minutes
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Program provides participants w/ an update on new guidelines for the management of asthma, roles that pharmacists can play in the treatment of patients w/ asthma, and the role that medications affecting leukotriene synthesis or action may play in therapy.
DVD / 60 minutes
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