Permit To Work
Types of Permit To Work
Hot Work Permit
Confined Space Entry Permit
Electrical Permit
Excavation Permit
Radiography Permit
Crane Critical Lifts Permit
Man Basket Operation
Permit Issuer Responsibilities
Permit Receiver Responsibilities
HSE Permit Coordinator
Responsibilities
Revalidation of the Permit
Work Permit Flow Chart
This presentation is contain information about Documentation System of Pharmaceuticals. This presentation is prepared for training on documentation in Drug International Limited (Herbal Division) Depending on WHO and ICH guideline.
Permit To Work
Types of Permit To Work
Hot Work Permit
Confined Space Entry Permit
Electrical Permit
Excavation Permit
Radiography Permit
Crane Critical Lifts Permit
Man Basket Operation
Permit Issuer Responsibilities
Permit Receiver Responsibilities
HSE Permit Coordinator
Responsibilities
Revalidation of the Permit
Work Permit Flow Chart
This presentation is contain information about Documentation System of Pharmaceuticals. This presentation is prepared for training on documentation in Drug International Limited (Herbal Division) Depending on WHO and ICH guideline.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
Basic Principle of GDocP, Good Documentation Practices, ALCOA, ALCOA+, MHRA and Eudralex Guidlines, Effective GDocP, Common GDocP errors, Benefits of GDocP, GDocP Improvement, GMP, Pharmaceutical
STANDARD OPERATING PROCEDURE FOR PUBLISHING COURTESY
ADVERTISEMENT, SPONSORSHIP& OTHER PUBLICITY INITIATIVES BY SECL MBA/BBA presentation Pune University/Mumbai University/kolkata university / Best PPT
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
Basic Principle of GDocP, Good Documentation Practices, ALCOA, ALCOA+, MHRA and Eudralex Guidlines, Effective GDocP, Common GDocP errors, Benefits of GDocP, GDocP Improvement, GMP, Pharmaceutical
STANDARD OPERATING PROCEDURE FOR PUBLISHING COURTESY
ADVERTISEMENT, SPONSORSHIP& OTHER PUBLICITY INITIATIVES BY SECL MBA/BBA presentation Pune University/Mumbai University/kolkata university / Best PPT
PECB Webinar: Aligning ISO 25000 and CMMI for DevelopmentPECB
We will cover:
• Overview of ISO 25000 - Software Product Quality Requirements and Evaluation (SQuaRE)
• How CMMI for Development best practices address development activities
• Complementary values that ISO 25000 and CMMI bring
• How ISO 25000 and CMMI help software development and service companies to improve customer satisfaction
Presenter:
This webinar will be presented by PECB Trainer Orlando Olumide Odejide, an experienced Enterprise Architect and Chief Trainer for Training Heights Limited
standard operating procedure are the important document for pharmaceutical company & organization which may follow reference copy of the manufacturing batch or lot.
3. Learning Objectives:
Upon completion of this learning session,
the participants will be able to:
1. Write correct SOP’s
2. Relate department SOPs to the overall
objectives of the company
3. Understand the importance of applying
SOP’s
4. Update existing SOP’s to meet current
changes and improvements in the
company
5. Include SOP as part of training during the
Induction of a new staff
4. Contents:
1. Standard Operating
Procedures:
1.1 Define SOP’s
1. 2 Creating SOP’s
1. 3 Why do we need SOP’s:
A) With SOP we have
B) Without SOP we risk
2. Application of Standard
Operating Procedures:
2.1 Applying SOP’s
2. 2 Making sure your staff
follow SOP’s
2. 3 Using SOP’s during
Induction for new staff
2. 4 Reviewing & Updating
SOP’s
5. Standard Operating Procedures:
1.1 What are Standard Operating
Procedures (SOPs)?
- They are written instructions
intended to document how to perform
a routine task or activity or It is a
document consisting of step-by-step
information on how to execute a
task. It is really just a checklist.
6. Standard Operating Procedures:
1. 2 Creating and Maintaining
SOP
5 Steps:
1. Identify and develop a list of
processes that you believe
need SOP.
2. Plan the Process for developing
and managing SOPs
3. Collect information
4. Write, Review and Publish your
SOP
5. Maintaining your SOP overtime
7. Standard Operating Procedures:
1. 3 Why do we need SOP’s?
Compliance
Quality
WITH SOP, WE HAVE:
Staff Competency
WITHOUT SOP, WE RISK:
Inconsistency
Added costs
Inefficiency
8. Application of Standard Operating Procedures:
2. 1 Applying SOP’s
3 Important Steps for Supervisors:
1. Train and Demonstrate an SOP to the user
2. Explain the importance of accuracy in SOP
3. Ensure accessibility of SOPs for all
9. Application of Standard Operating Procedures:
2. 2 How to make sure that your staff follow SOP’s:
Four steps for managers/supervisors:
1. Monitoring
Staff must sign-off to show that they are trained
physically and theoretically on how to carry out a
process
Visibility
To use posters or signage as a way of reminding them
2. Measurement
Make SOP part of Employee Review process
3. Frequency
Make sure to inform staff if an SOP is updated so they
know you give importance to SOP’s
10. Application of Standard Operating Procedures:
2. 3 Why it is important to use SOP’s in the
induction of a new staff?
Reasons:
- Saves time and training costs
- Staff is guided to perform the tasks assigned
to his/her role
- Avoiding of delays and errors
- Have the knowledge of what is expected of
him/her
- Know who to report to
- Have a clear picture of the role of the
department in the company
- Understand the objectives of the department
11. Application of Standard Operating Procedures:
2. 4 The importance of Reviewing & Updating
SOP’s:
Reasons:
1. To avoid and rectify any dispute and
misconceptions with a process
2. To maintain effective, efficient and realistic
processes
3. To be in line with changes and improvements in the
company
4. To fill in any gaps in a particular process
5. To avoid outdated information
6. For auditing purposes
12. THAT IS ALL EVERYONE AND THANK YOU FOR YOUR TIME!!!
ANY QUESTIONS?