.Seminar Topics

GMP Compliance	Compliance	Regulatory Affairs,  Audits & Inspections
Validation	Manufacturing	Technologies
Quality Assurance	Quality Control	Research & Development
Microbiology	Chemical	Cosmetics
Food	Water	Other Related Topics

 GMP Compliance

The Current GMP`s

API GMP Compliance

Internal Audits

Applied cGMP’s for Pharmaceutical and Allied Industries

cGMP and Quality Issues for Biopharmaceuticals

cGMP for Pharmaceutical Production Supervisors

cGMP for Pharmaceutical Quality Control Laboratory Personnel

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 Compliance

Electronic Records and Signatures Compliance

Medical Device Design and Compliance

Supply Chain Process and Compliance

Auditing for cGMP Compliance

Compliance for biopharmaceuticals 

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Regulatory Affairs,  Audits & Inspections

Preparation, Planning, And Conquering FDA Inspections

FDA Inspections for non-US side

FDA Quality Systems Approach to Inspection           

How to Host an FDA/HPFBI Inspection 

Regulatory Affairs for Generics

Regulatory Affairs for Medical Devices

Chemistry & Manufacturing Control for Submission

Registration of Pharmaceutical Products

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Validation

Computerized Systems Validation (CVS)

CAPA - Corrective And Preventive Actions

Process Validation

Critical Process Cleaning and Cleaning Validation

Design Control and Product Validation

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Manufacturing

Manufacturing Processes and Controls

Advanced Solid Dosage Manufacturing Processes 

Bio Pharmaceutical Process Systems

Control of Microbial Contamination in Sterile and non Sterile Products

Mixing of Liquids and Complex Materials

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Quality Assurance 

Auditing and Inspecting Principal Research for GLP Compliance

Biosafety of Biological Drug products

Conducting Effective Quality Assurance Inspections

Chang Control / Deviation

Document and Management Control

Statistical Analysis of Laboratory Data  

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Quality Control

Quality System

Active Pharmaceutical Ingredients

Quality Control Systems - API To Consumer

Physical and Chemical Testing

Good Laboratory Practices (GLP)

Standard Operating Procedures (SOP’s)

Documentation and Technical Writing

Laboratory/Technical Training

Container-Content Testing

Pharmaceutical Stability Programs

Stability Studies, ICH Guidelines     

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Research & Development

ADME Fundamentals

Product Counterfeiting and Intellectual Property

Analytical Method Validation for FDA Compliance

In Vitro and in Vivo Evaluation of Dosage forms

Pharmacokinetic (PK) studies

Pathways to Skin Penetration

Pharmaceutical Process Development

Design of Experiment

Drug Development Stages

Scale-Up and Post Approval Changes Guidelines  

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Microbiology

Control of Microbial Contamination

Endotoxin Testing and Test Validation

Microbiological Control and Validation

Sterilization in Pharmaceutical Industry  

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Technologies

 Pharmaceutical Aerosol Technology

Pharmaceutical Coating Technology

Drug Delivery Technology

Pharmaceutical Technology Transfer

Encapsulation Basic Techniques and Applications

Microencapsulation and Particle Coating

Sterilization Technologies

Powder Mixing Technologies 

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Chemical

 Emulsion – Suspension Technology

Surfactant, Colloids and Interfaces

Water Based Polymers

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Cosmetics

Cosmetics Product Formulation

Skin Product Development 

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Water

Pharmaceutical Water and the International Regulatory Environment

Pharmaceutical Water System

Pharmaceutical Water, Chemistry, System Design and Validation  

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Other Related Topics

 Annual project reviews for Pharmaceuticals

Monitoring Clinical Trials

Fundamental Concepts for Protecting Intellectual Property in Pharma

Good Clinical Practices, a Global Approach

Post Approval and Changes to the Marketed Drug Products

Adverse Drug Events: Monitoring and Reporting

Complaints Handling and MDR Reporting

Effective Project Management

Packaging of Pharmaceuticals

Pharmaceutical Laboratory Information Management system

Patent Law for Managers, Engineers and Scientists

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