In training to be incorporated the below

Good Manufacturing Practices

1. Good Manufacturing Practices related to Products,Processes,Premises,People & Procedures
2. Good Manufacturing Practices related to Equipments,Instruments,Materials like Raw material,Packaging material
3. Good Manufacturing Practices related to regulatory requirements & cGMP norms

Good Documentation Practices & Data Integrity

1. Knowledge of ALCOA+ principle
2. To overcome the Data integrity issues covered - a) Quality audits, b) Quality documentation,
   c) Quality training, d) Cost of Quality, e)Quality standards
3. For Awareness and build capabilities for ensuring data integrity - a) Training, b) Internal audits,
   c) Upgrading the systems, d) Policies, e) Cultural environment, f) Tone from the top, g) Adequate infrastructure, h) Management support

Quality Culture

1. Management expectations from employees in terms of Behavoural,Hygiene
2. Management vision,Mission,Cultural environment in organization
3. To manufacture the products with inbuilt the Safety,Purity,Efficacy & Quality products
4. To maintain the facility with timely preventive maintenance of the equipments,Instruments
5. Timely calibration & Qualification of equipments & Instruments
6. To keep the online documentation like Logbooks, BMR's, BPR's,SOP's etc
7. To maintain the standards with top Pharma companies
8. To develop the culture in organization to achieve the goals
9. To train the employees related to their job & to verify the effectiveness

Behaviour & Hygiene

1. In premises behaviour & to maintain the hygiene
2. DO's and DON’T's
3. Employees culture development program
4. Motivational program
5. To reduce the attrition rate

Aseptic Practices ,Microbiology & Sign language

1. Personal behavior
2. Personal hygiene & cleanliness of areas
3. Gowning procedure to Employee for Entry & Exit procedure in Aseptic area
4. DO's & DONT's in Aseptic area
5. Sign languages to avoid the contamination
6. Hand sanitization in Aseptic area
7. Hand gloves wearing in Aseptic area

Environment Health & Safety

1. Safe and friendly environment for leaarning
2. Accident free environment
3. Safety,Health environment legal compliance
4. Fire fighting system ( Fire extingisher & Hydrant line)

Inspection of Containers like Vial,Ampoule,PFS,Cartridge

1. Automatic visual inspection machine Operation
2. Manual inspection procedure to operators
3. For Automatc visual inspection machine KNAPP kit preparation & KNAPP test,Validation kit,Inspection machine qualification
4. Yield improvement on Visual inspection machine
5. False rejection control on automatic inspection machine
6. For handling of Brevetti / Seidenader machine operator training

Warehouse Management

1. Advantages of Warehouse Management - a) Space utilization b) Effective equipment utilization,
   c) Labor utilization, d) Accessibility of all materials
2. Types of Warehouse
3. Inventory control in warehouse & function
4. Economic order of quantity
5. Inventory level
6. Stores management

SAP: MM/PP/QM/PPDS/WM module -

SAP MM:

1. Organizational Structure of SAP MM
2. Material Master
3. Vendor Master
4. Purchase Requisition (PR)
5. Inventory Management

SAP PP:

1. SAP S/4HANA Production Planning Overview
2. Master Data for SAP S/4HANA Production Planning
3. Prerequisites and Tools for Advanced Planning in SAP S/4HANA
4. Demand Management in SAP S/4HANA with Planning Strategies
5. Advanced Production Planning in SAP S/4HANA
6. Detailed Scheduling in SAP S/4HANA

SAP QM:

1. QM Organizational Structure
2. QM Master Data
3. QM Processes

SAP PPDS:

1. Create master data
2. Process the Supply Chain Model
3. PP planning procedures
4. Detailed Scheduling

Deviation,Investigation & CAPA Management

1. Deviation management
2. Elements of an effective deviation management program
3. Deviation flow chart
4. How to perform investigation
5. Investigation ( Root cause analysis),Corrective and preentive action(CAPA),Effective monitoring,Statical evaluation,Trending of Deviations
6. Overview of Quality management system and its continuous improvement

QAMS: Change Control, Devaition, CAPA, Markert complaints, Investigation -

1. Defination of Change contol
2. Principals of Change contol
3. Regulatory requirements
4. Steps of Change contol
5. Classification of Change contol

DMS: SOPs, Annexures, management of logbooks and format books -

1. Aim of SOP
2. Objectives
3. Benefit
4. Purpose
5. SOP writing style
6. SOP format
7. Do's
8. Don'ts
9. General format for SOP
10. SOP Process
11. What kind of SOP needed?
12. Types of SOP
13. SOP Content
14. SOP Development

LIMS: Mangement of samples and its Analysis, QC chemicals inventory, trouble shooting and its integration with other modules -

1. Basics of LIMS
2. The purpose of LIMS
3. Implementation
4. Advantages of LIMS system

Training: Induction / Dept. / Annual / SOP / Batch record its effectiveness -

1. Different types of training in Pharmaceuticals
2. Importance of training
3. GMP related training

Tech Transfer and product development -

1. Importance of Tech transfer
2. Pahses of transfer
3. For new product development technical guidance
4. Regulatory submission timelines & approval

Devlopment of artworks and packing materials -

1. Importance of Tech transfer
2. Importance of training
3. GMP related training

Preparation of Batch records such MFR, MPR, BMR and BPRs.-

1. What is batch records
2. Importance of batch records
3. Different stages in batch records

Electronic batch management and logbook management -

1. Importance of eBMR for Pharma E-log management

Regulatory audits handling -

1. Guidance for audit prparation
2. Mockdrill for Audit & flow to represent to auditors
3. Overall audit Compliance & auditors expectations