cGMP Training Video Packs: Practical Guides
Make GMP Training and learning more accessible and convenient for all your personnel.
No one denies that GMP training is a good thing; the difficulty, however, is in organizing it. Though everyone should be trained, from operator level to management, getting them together is one challenge; and how long they can be spared (to stay away) from their routine jobs without compromising operations is another challenge; and what topics to choose and the depth of coverage of each, is still yet another challenge.
Then there is the omnipresent constraint of "budgets" for training. Who should train? What are the fees? What are the other expenses? Can we afford it?
Recognizing these dilemmas in the industry, Center for GMP offers you a unique solution: take the training to the individual instead of having the individual come to the training. Make it such that any one, motivated to learn and improve, can visit your Library and access training on any topic of interest, any time, any number of times (almost till one can recite the entire presentation verbatim), whenever free, or when not too busy.
Center for GMP offers training videos that your employees, regardless of which department or level they belong to, can benefit from GMP training at their own individual convenience.
These training videos are organized in packs, each presented as a practical, easy-to-implement guide: Standard GMP, Standard GLP and Special Topics. The standard packs touch on day to day issues on the shop floor and laboratory. The advanced pack is for specialists involved with Quality Management, Engineering and Projects. Each topic is carefully researched, and more comprehensively presented than ever possible in a live, face-to-face session.
These GMP Training Videos are not
"sold" as
"products"; instead, like software, they are
"licensed" under our
End User Licence Agreement (EULA) for a modest one-time fee. This licence is site-specific, and these videos may be viewed by your employees located at the
specified site only. The Licencee is not permitted to transfer or move these for viewing at any other site. If you would like these videos made available at other sites also, an additional one-time fee will be charged.
| Pack | S/N | Module Title | Duration | Content |
| | ........................ | |
Standard GMP
Licence Fee:
INR 250,000/- | 1 | An Overview of cGMPs: GMP & You! | 108 min | Creates awareness of GMP and endeavours to motivate for "real" compliance at every level of the organisation |
| | 2 | Integrated Pharmaceutical Contamination Control | 108 min | Discusses initiatives necessary to minimise risk of contamination from Personnel; Buildings and Facilities; Equipment; Raw Materials; In-process and Finished Materials; Packaging and Labelling; Sampling and Testing |
| | 3 | Pharmaceutical Materials | 108 min | Material clearances and flows; Vendor Qualification and Status Grading; Good Sampling Practices; Shop floor issues |
| | 4 | Pharmaceutical Manufacturing | 120 min | Production and Process Controls; Shop floor issues; Managing Production Deviations and Change Control |
| | 5 | Good Documentation Practices | 96 min | |
| | 6 | Conducting Failure Investigation and CAPA | 138 min | All you wanted to know about carrying out effective failure investigation and implementing CAPA |
| | 7 | Facing an Inspection | 90 min | All you wanted to know about preparing for and successfully facing an Inspection or external audit |
| | 8 | Conducting Pharmaceutical Audit | 186 min | All you wanted to know about carrying out effective Internal and external audits, including QSIT Approach to Quality Management and Audit |
| | ........................ | |
Standard GLP for Pharma QC
Licence Fee:
INR 150,000/- | 1 | GLP for Pharmaceutical QC Laboratories | 90 min | Overview of OECD GLP; Overview of ISO 17025 GLP; Overview of Schedule L-1 GLP; Checklist for Compliance |
| | 2 | Good Sampling Practice | 36 min | Good (Statistically Valid) Sampling Plans and Practices |
| | 3 | Good Measurement Practices | 240 min | Overview of Measurement System Analysis; Calibration Management; Importance of Correct Techniques; Verifying Compendial Methods; In-depth and practical coverage of Validation of in-house developed Analytical Methods; Validation of PCR family of Methods |
| | 4 | Handling OOS Test Results | 12 min | Handling "atypical" and "OOS" Test Results |
| | 5 | Stability Studies | 102 min | Forced degradation studies; developing and validating stability indicating analytical method; and general practical tips for a successful and meaningful study |
| | ........................ | |
Pharmaceutical Quality Management & Process Validation
Licence Fee:
INR 150,000/- | 1 | Pharmaceutical Quality Risk Management | 150 min | In-depth and practical coverage of ICH Q9 (QRM) |
| | 2 | Pharmaceutical Process Validation | 312 min | In-depth and practical coverage of the New Compliance Policy Guide including ICH Q8 (QbD)and PQLI |
| | ........................ | |
Pharmaceutical Cleaning Validation
Licence Fee:
INR 75,000/- | 1 | Pharmaceutical Cleaning Validation | 204 min | In-depth and practical coverage of Cleaning Validation |
| | ........................ | |
Buildings & Facilities
Licence Fee:
INR 250,000/- | 1 | Pharmaceutical Premises | 96 min | Overview of regulatory expectations and suggestions for re-visiting and improving upon conventional layouts |
| | 2 | Pharmaceutical Environments | 380 min | Basics of airborne contamination control; Cleanroom Air Classification; Tips for design; Understanding how a HEPA filter works to harness its full potential; Testing & Qualification of Pharmaceutical Environments; Overview of Instant/Rapid Microbial Detection Methods
|
| | 3 | Pharmaceutical Waters | 174 min | Overview of regulatory expectations and Validation |
| | ........................ | |
Sterile Processing
Licence Fee:
INR 75,000/- | 1 | Sterilisation & Aseptic Processing | 204 min | Comprehensive exposition of sterilisation concepts; sterilisation cycle development; Qualification/Verification of Autoclaves, DHS, Tunnel Sterilisers; Media Simulation Studies; Overview of Instant/Rapid Microbial Detection Methods |
| | 2 | Sterile Area & You | 37 min | Discusses the human interface in controlled, sterile and aseptic environments and stresses the importance of good gowning and comportment for effective contamination control. |
| | ........................ | |
Biosafety
Licence Fee:
INR 50,000/- | 1 | Good Biosafety Practices | 144 min | Why Biosafety is so important, Risk Assessment and Risk Control, Proper selection and use of Biosafety Cabinets; Considerations in Design of Biosafe Facilities
|
| | ........................ | |
