S.
No.
|
Title
|
Duration
|
Remarks
|
1
|
Auditors Qualification:
Conducting and facing Audits
|
4-5 hours. It can be
delivered up to 8 hours also based on requirement.
|
Covers practical exercises,
Videos and Role plays with relevant examples.
|
2
|
Good Manufacturing Practices:
Basics
|
2 -4 Hours standard module.
|
Covers examples, videos and
specific guidelines focus.
|
3
|
GMP
– Details and Guideline Focus
|
20 hours program
|
Covering all the major
guidelines, examples, videos and review skills.
|
4
|
Diploma in Regulatory Affairs
|
40 Hours (One month program)
|
Covering all guidelines,
patents, regulatory requirements and Filings requirements.
Example based, videos, Group
discussions and assignment based program.
|
5
|
Statistical Tools in pharmaceutical
industry: & Root Cause Analysis (RCA)
|
2-3 hours program
|
Covers all the important
tools including FMEA, Pareto, Fish Bone and so on which are widely used in
industry.
Also examples, exercises,
case studies are undertaken to clarify the same.
|
6
|
Business Communication Skills
–
Effective Communication.
(Soft skill enhancement)
|
4-5 Hours program
|
Covers concepts like –
Principles of effective communication, importance of listening, Questioning
techniques and non-verbal communication skills.
Activity based and
interactive program.
|
7
|
Good documentation Practices
- GDP
|
2-3 hours Program
|
Covers all basic requirements
of documentation, types of documents and practices followed.
|
8.
|
Change Controls
|
2 hours program
|
Covers all the regulatory
changes and their impact on the practices with a maximum of examples.
|
9.
|
Quality Management System –
QMS
|
4-5 hours program
|
Covers all the Quality
related activities and documentation ensuring compliance to the regulations.
|
10.
|
Quality Assurance Program
|
4-5 hours program Based on
the needs can be extended to 20-30 hours
|
Covers all the regulatory
requirements and documentation, examples, videos, assignments, Group
discussions and activity based program.
Covers concepts like
QbD(Quality by design) and Risk Assessment
|
11.
|
Program on Risk Assessment in
Pharmaceutical industry
|
2-3 hours Program
|
Covers concepts like FMEA
which is based on ICh Q9 approach.
|
12.
|
Validation basics
|
2-3 hours Program
|
Covers cleaning validation,
process validation and equipment validation approaches.
|
13.
|
Advanced pharmaceutical
technologies
|
10 to 20 hours program
|
Covers all the specialized
dosage forms and recent trends on their developments.
|
14.
|
Recalls and warning letters
in pharmaceutical industry
|
3-4 hours program
|
Covers all the non-compliances
and related examples with specific notes.
|
15.
|
Scale Up in Pharma industry
|
8 hours program
|
Covers all the important
steps and related facts necessary for bringing the product from lab to
industrial scale.
|