2 Day In-Person Seminar by Ex-FDA Official on Pharmaceutical cGMP, Data Integrity and FDA Inspections – Current Challenges and Preparations

Compliance Trainings, Mumbai
2016-09-29

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 Ahead

WHO 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

Brian G. Nadel, Former FDA Investigator and Compliance Officer at FDA CDER

Mr. Brian G. Nadel is currently President of Brian G.Nadel GMP Consulting, LLC. He provides independent cGMP Consulting Services for pharma and API manufacturers. He has over 25 years of diverse experience in Pharmaceutical QA and Quality Systems, Pre-Approval Inspections, International cGMP auditing for finished products, API and Process Validation.

He has conducted numerous cGMP training for FDA, Industry, and at industry conferences. He has worked as US FDA Investigator and was then promoted to the FDA’s Center for Drug Evaluation and research (CDER), where he served as a Compliance Office in the office of Compliance, Division of Manufacturing and Product Quality.

For more information click below link

http://compliancetrainings.in/shop/seminars/pharmaceutical-cgmp-data-integrity-and-fda-inspections-current-challenges-and-preparations/