COURSE DESCRIPTION
What are the Current Good Manufacturing Practice regulations (cGMP) for Finished Pharmaceuticals (cGMP)? Why is it required to follow these regulations? This seminar will provide a review of cGMP regulations with explanations that will demonstrate the benefits of complying with these simple rules.
You will learn how to prepare for and what is the appropriate conduct during FDA Inspections. Acquire the suitable skills necessary for responding to FDA’s questions. Descriptions of what records you have to provide and what records you should not provide to FDA. Learn how to write a procedure for preparing for FDA and other regulatory agency inspections.
The importance of data integrity and control of electronic records, with particular regards for recent problems with Indian API manufacturers. A comprehensive review of having and following written laboratory investigation procedures. Providing and maintaining adequate audit trails for traceability to your original data.
A short role playing exercise will be conducted, which will help you to learn appropriate behavior during regulatory inspections.
LEARNING OBJECTIVES
cGMP for Finished Pharmaceuticals
cGMP for APIsBuildings & Facilities, Equipment, Control of Components
Production and Process Controls, Laboratory Controls
Documentation, Change Control, Process Validation
Quality Protocols
Data Integrity
Electronic Records and Signatures
FDA Inspection Guides
Top 10 most common cited FDA Inspectional Observations (cGMP deficiencies)
Recent FDA Warning Letters
Indian Pharma and Challenges AheadWHO WILL BENEFIT
A must attend seminar for professionals in Pharmaceutical development and quality control companies, Manufacturers of drug substances (APIs), Finished Products, Contract laboratories and Clinical Research Organizations
DEPARTMENTS:
Quality Control & Quality Assurance
Research and Development Engineering
Regulatory Compliance
Manufacturing and Facilities
Validation Production
Documentation Supply Chain and Logistics
PROFESSIONALS:
Vice-Presidents
Directors
Senior Managers
Managers Senior Engineers
Engineers Supervisors
Team Leaders
GMP Training Specialists
What are the Current Good Manufacturing Practice regulations (cGMP) for Finished Pharmaceuticals (cGMP)? Why is it required to follow these regulations? This seminar will provide a review of cGMP regulations with explanations that will demonstrate the benefits of complying with these simple rules.
You will learn how to prepare for and what is the appropriate conduct during FDA Inspections. Acquire the suitable skills necessary for responding to FDA’s questions. Descriptions of what records you have to provide and what records you should not provide to FDA. Learn how to write a procedure for preparing for FDA and other regulatory agency inspections.
The importance of data integrity and control of electronic records, with particular regards for recent problems with Indian API manufacturers. A comprehensive review of having and following written laboratory investigation procedures. Providing and maintaining adequate audit trails for traceability to your original data.
A short role playing exercise will be conducted, which will help you to learn appropriate behavior during regulatory inspections.
LEARNING OBJECTIVES
cGMP for Finished Pharmaceuticals
cGMP for APIsBuildings & Facilities, Equipment, Control of Components
Production and Process Controls, Laboratory Controls
Documentation, Change Control, Process Validation
Quality Protocols
Data Integrity
Electronic Records and Signatures
FDA Inspection Guides
Top 10 most common cited FDA Inspectional Observations (cGMP deficiencies)
Recent FDA Warning Letters
Indian Pharma and Challenges AheadWHO WILL BENEFIT
A must attend seminar for professionals in Pharmaceutical development and quality control companies, Manufacturers of drug substances (APIs), Finished Products, Contract laboratories and Clinical Research Organizations
DEPARTMENTS:
Quality Control & Quality Assurance
Research and Development Engineering
Regulatory Compliance
Manufacturing and Facilities
Validation Production
Documentation Supply Chain and Logistics
PROFESSIONALS:
Vice-Presidents
Directors
Senior Managers
Managers Senior Engineers
Engineers Supervisors
Team Leaders
GMP Training Specialists
