*** Notice: For the protection of property rights, this catalog is available for online browsing only. Please drop us a line if you would like to receive a copiable version of this catalog. Thank You!
Good Manufacturing Practice
An Introduction to Good Manufacturing Practice is our latest and most comprehensive training program on the subject. Presented in 11 parts with detailed 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.
Why do we need GMP?
A Quality System
Quality Assurance & Quality Control
Validation
Documentation
Change Control & CAPA
The environment, equipment & maintenance
Contamination & cleaning
Logistics, materials handling & distribution
Packaging & labeling
GMP, people & training
Review
DVD / 2017 / 46 minutes
[Go top]
>>> Add Cart <<<
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 / 2017 / 47 minutes
[Go top]
>>> Add Cart <<<
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!'
Why working here is different
The principles of Good Manufacturing Practice
Control of the manufacturing process
Record keeping
The product and you
Summary
DVD / 2009 / 27 minutes
[Go top]
>>> Add Cart <<<
The process of converting starting materials into a finished product invariably requires plant and equipment. In pharmaceutical manufacture, engineering is involved in four broad areas;
the design of premises
the maintenance of premises
the design of equipment & utilities
the maintenance of equipment & utilities
Includes:
The Place of Engineering & Maintenance
Facility Design
Engineering & Facility Maintenance
Engineering & Equipment Design
Maintenance
DVD / 2008 / 32 minutes
[Go top]
>>> Add Cart <<<
The physical packaging and labeling of pharmaceuticals is not dissimilar to packaging and labeling many other products, with pharmaceuticals however, the consequences of getting it wrong are severe. It isn't just that taking the wrong drug won't improve the patient's condition, it could, in some cases, worsen the condition or even kill the patient.
The same goes for taking the wrong dosage - an overdose of some drugs can be lethal. So, control over packaging and labeling is somethingthat GMP takes very seriously.
Pharmaceutical packing
Assessing the risks
Doing the audit
Auditing the packaging supplier
DVD / 2008 / 15 minutes
[Go top]
>>> Add Cart <<<
The manufacture of creams and ointments are not expected to be sterile but there must be very thorough microbiological controls throughout their manufacture, which is a critical point of focus in auditing the facilities where they are being manufactured.
Making topical products
Starting the audit
Topicals manufacture
Filling & packaging
DVD / 2008 / 19 minutes
[Go top]
>>> Add Cart <<<
A comprehensive multimedia step-by-step training program for all who are involved in the manufacture of tablets.
General considerations
Contamination control
Personnel considerations
The production stages - Blending; Granulation; Drying; Compression
Review
DVD / 2008 / 20 minutes
[Go top]
>>> Add Cart <<<
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.
Health and healthcare
GMP
Controlling the where - premises and the environment
Controlling the what - ingredients and contaminants
Controlling the how - the process
Controlling the who - people
Summary
DVD / 2008 / 25 minutes
[Go top]
>>> Add Cart <<<
Medication such as tablets and capsules are innocuous looking objects that may contain a multitude of ingredients for a multitude of purposes, from relieving headaches to more serious remedial actions.
Mainstream product they may be, but auditing them for content, methods and quality, is a core auditing skill.
Auditing tableting & solids
Contamination control
Auditing each stage of production
Review
DVD / 2007 / 17 minutes
[Go top]
>>> Add Cart <<<
This is where the starting materials are measured out in the correct amounts in preparation for manufacturing into finished products.
Dispensing is an activity that can give rise to many potential mistakes, which is what GMP sets out to prevent and what we have to bear in mind as we audit the area.
The Go Wrong Things of Dispensing
Separate, Clean & Decent
Dispensary Procedures
DVD / 2007 / 13 minutes
[Go top]
>>> Add Cart <<<
The warehouse is the physical interface between the GMP regulated pharmaceutical manufacturing facility and the rest of the world. An audit must start somewhere and it is logical to follow the process flow. The starting point of virtually all process flows is the warehouse.
An audit must start somewhere
Goods reception area
Sampling area
The building & housekeeping
Organization
Special requirements
DVD / 2007 / 16 minutes
[Go top]
>>> Add Cart <<<
A training and education program with brilliant graphics that completes an A to Z course on microfilters.
Introduction to microfilters
Filter types
Design & construction
Filter process & operations
Validation & integrity testing
Review
DVD / 2006 / 45 minutes
[Go top]
>>> Add Cart <<<
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.
Introduction
Hand washing
Scrub-up
Summary
DVD / 2005 / 18 minutes
[Go top]
>>> Add Cart <<<
A complete nine-part training course on the requirements of GMP as it impacts on materials handling, warehousing and distribution.
An introduction to GMP
What is logistics
Facilities & personnel
Documentation
Labeling and marking
Incoming goods
Goods in store
Shipping
Review
DVD / 2005 / 45 minutes
[Go top]
>>> Add Cart <<<
This video 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.
Introduction
Packaging for healthcare
Packaging materials
Primary & secondary packaging
cGMP
People and packaging
The packing process
Documentation
Summary
DVD / 2005 / 23 minutes
[Go top]
>>> Add Cart <<<
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.
Introduction
The head
Cosmetics & makeup
The body
The hands
Jewelry
Health
Summary
DVD / 2005 / 18 minutes
[Go top]
>>> Add Cart <<<
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.
An introduction to GMP and its importance
Contamination in the environment
GMP, people, personal hygiene and behavior
Review
DVD / 2005 / 22 minutes
[Go top]
>>> Add Cart <<<
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.
Why Good Manufacturing Practice
GMP & Engineering
Engineering & GMP Compliance
GMP, People & Behavior
Working in Clean Conditions
GMP, Tools, Clothing & Access
Change Control
Calibration
Summary
DVD / 2005 / 36 minutes
[Go top]
>>> Add Cart <<<
This multi-media training products 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.
Microorganisms: what are they?
Where do they live?
Why do we need to control them?
How do they get into our products?
How do we find them?
How do we control them?
Sterile products and clean conditions
Review
DVD / 2005 / 32 minutes
[Go top]
>>> Add Cart <<<
This video provides an introduction and overview to non-specialists who will be exposed to various aspects of validation at both managerial and operator levels.
Introduction
Why validation?
The principles of validation
Validation methods
Case study 1 - A greenfield project
Case study 2 - Validating a new purified water system
Case study 3 - Validating a product for conract manufacture
Validating computer systems
Review
DVD / 2005 / 38 minutes
[Go top]
>>> Add Cart <<<
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.
About validating cleaning
The cleaning strategy
The cleaning validation protocol
Determining limits for residues
Sampling techniques
Sampling analysis
Test methods
Change control procedures
Post validation surveillance
Summary
DVD / 2005 / 28 minutes
[Go top]
>>> Add Cart <<<
This module provides a comprehensive overview of all aspects of water, the most commonly used material in the manufacture of GMP compliant products.
Introduction
Feed water quality
Water quality
Water purification methods
Purified & WFI water systems
Storage & distribution
Maintenance
Cleaning & sterilization
System validation
Conclusion
Review
DVD / 2005 / 32 minutes
[Go top]
>>> Add Cart <<<
***Price on web-site may not be current and is subject to modification by quotation***
