GMP Professional lectures schedule Part I I

Day 1
D. Specifications

1. Types of specifications

2. Test data and specifications

3. Specifications revision

E. Laboratory record-keeping and data requirements

1. Record

2. Record-keeping requirements

3. Certificates of analysis (COAs)

Day 2
F. Laboratory handling controls

1. Sample identification

2. Reagents, solutions, and standards identification

3. Storage requirements

G. Stability programs

1. Release tests vs. stability-indicating tests

2. Stability test data

3. Stability-point failure

H. Reserve samples and retains

Day 3
A. Facilities (Module 4)

1. Buildings

2. Manufacture and storage environment

3. Facilities change

Day 4
B. Utilities

1. Water supply systems

2. Compressed air and gas systems

3. Utility design for production

4. Utilities design specifications

5. Utilities change control

Day 5
C. Equipment

1. Equipment planning

2. Equipment layout

3. Equipment cleaning and maintenance

4. Equipment cleaning validation or verification

5. Equipment change control

D. Qualification and validation

E. Maintenance and metro logy systems

1. Maintenance

2. Metro logy change control

Day 6
F. Cleaning, sanitization, and sterilization systems

1. Washing facilities

2. Cleaning procedures

3. Sanitization procedures

4. Pest control

5. Sterilization processes

G. Automated or computerized systems

1. Validation procedures

2. Open and closed computerized systems

3. Configuration control

4. Security requirements

Day 7
A. Receipt of materials

1. Incoming materials

2. Inventory transactions

B. Sampling processes

1. Sampling plans

2. Sampling environment

3. Cleaning

C. Material storage, identification, and rotation

1. Storage suitability

2. Storage labels

3. Stock rotation

4. Retest dates vs. expiration dates

5. Mix-up risk

Day 8
D. Shipping and distribution

1. Temperature-sensitive requirements

2. Special requirements

3. Report requirements

4. Supply chain security

A. Master batch and completed batch records

1. Required elements

2. Record processing requirements

B. Production operations

1. Application factors

2. Utility requirements

3. Sanitization and protection

C. In-process controls

1. In-process testing

2. Critical process parameters (CPPs)

3. Process capability studies

4. Specification limits

D. Dispensing and weighing controls

1. Staging areas

2. Dispensing materials

E. Requirements for critical unit processes

1. Parameters for sterilization

2. Validation studies

3. Unit processes

4. Operating procedures

5. Reevaluation and revalidation

6. Environmental monitoring requirements

7. Monitoring tools

F. Contamination and cross-contamination

1. Sources

2. Risk mitigation

Day 9
G. Reprocessed and reworked materials
Disposition process
Storage
– HVAC SYSTEM

 

Day 10
1-Mutual recognition agreements

2-Risk assessment

Day 11
H. Business continuity and disaster recovery planning
Supply chain impact
Contingency plan
E.Traceability and sourcing (Rest of Module 5)

Traceability requirements
Biological agent requirements
Pedigree and sourcing requirements
F.Salvaged/returned goods and destruction

Disposition Review
Destruction facilities and processes
Day 12
A. Filling operations and controls

1. Materials control

2. Filling equipment control

3. Contamination controls

4. Staged materials

5. Status labeling

B. Environmental monitoring

C. In-process and finished goods inspections

Finished goods inspections
Vision and detection systems
Defect characterizations
Equipment failure detection
D. Parenteral product inspection

Staff evaluation
Automated inspection processes
Defect library
Inspector requirements
E. Packaging operations and controls

Content protection
Qualification and maintenance of equipment
Line clearance operations
Quality check criteria
Cut-label procedures
Hand-applied label procedures
Production process controls
Contamination controls
Tamper-evident packaging
F.Labeling operations and controls

Label printing in packaging
Quality of print used
Label reconciliation
Label changes
Unused labels
Day 13
A. Quality by design concepts

1. Critical quality attributes (CQAs) and critical process parameters (CPPs)

2. Design space

3. Process analytical technology (PAT) tools

3. Combination products

4. Clinical trials material

C. Raw materials, packaging, and infrastructure for product development

D. New product development studies and reports

E. Scale-up and transfer activities

1. Development and validation reports

2. Technology transfer types

3. Transfer efficiency

Day 14&15 &16
Revision & FINAL Exam OR ASQ* Exam