Pharmaceuticals Professional Development PDF Print E-mail

Amreteck® is a USA based worldwide Quality, Validation & GxP Compliance Consultancy Company which provides services to the pharmaceuticals, medical and Biotech companies.  Now Amreteck® USA offers Online Training for the following Pharmaceuticals courses:

1.       Pharmaceuticals - 101

2.       Validation - 101

3.       Validation - 201

4.       Validation - 301

5.       Quality Assurance - 101

6.       Quality Assurance - 201

7.       Audit/Compliance - 101

8.       GMP - 101

9.       GMP - 201  

WHO WILL BENEFIT 

Ø  Pharmaceuticals Professionals including manufacturing operators

Ø  Students who plan to career in pharmaceutical companies 

Ø  Drug Regulatory Inspectors

Ø  Management of Pharmaceuticals, Medical & Biotech Companies

POTENTIAL BENEFIT 

Ø  Share US pharmaceuticals knowledge, working experience & expertise 

Ø  Workshop with document/protocols examples

Ø  Share US FDA requirements & expectation and how to accomplish it

Ø  Provide tools & techniques on developing pharmaceuticals departments and its responsibilities

Ø  Provide solution as well as share regulations and expectation in the pharmaceuticals companies

Ø  Develop adequate Pharmaceuticals professionals to perform their job with knowledge, confidence and directly help in manufacturing high quality drugs

Ø  Prepare students for pharmaceuticals job and/or help to expand career opportunity

Ø  Help in obtaining international pharmaceuticals market recognition (US, EU, ANVISA Brazil, Health CANADA, WHO, JP, MHRA, etc.) and trust in manufacturing high quality drugs

Ø  Enhance job performance to the current pharmaceuticals employees to maximize company’s profit

FEES, LOGISTICS & SESSION 

Ø  Course Duration – Two days per course [3 hours per day with unlimited Q & A] 

Ø  Cost – US$350 per course [Check Payable to “Amreteck LLC”, other method of payments are available]

Ø  Logistic Requirements – Computer, Phone, Internet access, Email address and Skype.

Ø  Registration –

·      Session 1: November 15 – December 06, 2013

·      Session 2: December 20 – January 10, 2014

·      Session 3: January 24 – February 14, 2014

COURSES DESCRIPTION

v  Pharmaceuticals - 101

Provide comprehensive understanding, regulations, expectation, criticality and complexity of drugs manufacturing and it business aspects for the pharmaceuticals manufacturing companies.  Share and explain various pharmaceuticals departments and its responsibilities; and how to accomplish it with providing working examples.

Learning Objectives & Areas Covered:

ü  Understanding GMP production requirements & expectation

ü  Understanding drugs manufacturing processes

ü  Understanding GxP (GMP, GCP and GLP)

ü  Understanding regulatory requirements & expectation

ü  Understanding Management, Manufacturing, Engineering, QA, QC, Validation, Regulatory Departments’ roles, responsibilities and expectation

ü  Understanding USFDA and others regulatory institutions responsibilities & expectation

ü  Understanding local and global pharmaceuticals markets and its competitions

ü  Share US Pharmaceutical companies working experience & expertise

ü  Provide tools & techniques to be prepared for new job and/or enhance working knowledge & experience

ü  Provide presentation through electronic media and unlimited questions and answers session

ü  Provide quizzes and share answers at the end of the course

ü  Provide certificates after completion of the course

v  Validation - 101

Provide comprehensive understanding and expectation of the qualification and validation activities, how to develop Master Validation Plan, Risk Analysis, Validation Project Plan documents and explain validation life cycle. Share examples of various validation protocols and activities.

Learning Objectives & Areas Covered:

ü  Understanding Qualification and Validation Life Cycles and its compliance

ü  Understanding types of Qualification and Validation requirements and its importance

ü  Provide tools and techniques on how to develop protocols

ü  Benchmarking qualification and validation documents with the pharmaceuticals industries

ü  Provide understanding, tools and techniques on how to develop MVP,  Risk Analysis and VPP documents

ü  Understanding Management, Engineering, QA, QC, Validation and Regulatory Departments responsibilities and expectation during Qualification & Validation activities.

ü  Understanding USFDA and others regulatory institutions requirements & expectation on Qualification & Validation

ü  Understanding how competent Qualification & Validation document help in manufacturing high quality drugs

ü  Share US Pharmaceutical companies validation experience & expertise

ü  Provide tools & techniques to be prepared for new job and/or enhance working knowledge & experience

ü  Provide document/protocols templates as necessary

ü  Provide presentation through electronic media and unlimited questions and answers session

ü  Provide quizzes and share answers at the end of the course

ü  Provide certificates after completion of the course

v  Validation - 201

Provide protocols, SOPs writing and execution techniques on Equipment/System, Utilities and Facilities qualification/validation. Share and explain testing requirements on each type of qualification and validation; and how to accomplish it with providing protocols examples.  Prerequisite is Validation - 101.

Learning Objectives & Areas Covered:

ü  Understanding System/Equipment, Utilities and Facility Qualification & Validation requirements & expectation

ü  Understanding and provide templates and techniques on how to write & execute System/Equipment, Utilities and Facility IQ/OQ/PQ protocols and SOPs

ü  Provide templates and techniques on how to write System/Equipment, Utilities and Facility IQ/OQ/PQ protocol summary reports

ü  Understanding the pre-execution protocols, post-execution protocols, summary reports development, review and approval process

ü  Benchmarking System/Equipment, Utilities and Facility qualification and validation documents for the pharmaceuticals industries

ü  Understanding Management, Engineering, QA, QC, Validation and Regulatory departments’ responsibilities and expectation during System/Equipment, Utilities and Facility Qualification & Validation activities.

ü  Understanding USFDA and others regulatory institutions requirements & expectation on the System/Equipment, Utilities and Facility Qualification & Validation

ü  Share US Pharmaceutical companies System/Equipment, Utilities and Facility qualification and validation working experience & expertise

ü  Provide tools & techniques to be prepared for new job and/or enhance working knowledge & experience

ü  Provide presentation through electronic media and unlimited questions and answers

ü  Provide quizzes and share answers at the end of the course

ü  Provide certificates after completion of the course


v  Validation - 301

Provide protocols, SOPs writing and execution techniques on Process, Cleaning and Computer Validation. Share and explain testing requirements on each type of validation; and how to accomplish it with providing protocols examples.  Prerequisite is Validation - 101.

Learning Objectives & Areas Covered:

ü  Understanding Process, Cleaning and Computer Validation requirements & expectation

ü  Understanding and provide templates and techniques on how to write Process, Cleaning and Computer Validation protocols and SOPs

ü  Understanding and provide techniques how to execute write & execute Process, Cleaning and Computer Validation protocols

ü  Understanding the pre-execution protocols, post-execution protocols, summary reports development, review and approval process

ü  Benchmarking Process, Cleaning and Computer Validation protocols for the pharmaceuticals industries

ü  Understanding Management, Engineering, QA, QC, Validation and Regulatory departments’ responsibilities and expectation during Process, Cleaning and Computer Validation activities.

ü  Understanding USFDA and others regulatory institutions requirements & expectation on Process, Cleaning and Computer Validation

ü  Share US Pharmaceutical companies Process, Cleaning and Computer Validation working experience & expertise

ü  Provide tools & techniques to be prepared for new job and/or enhance working knowledge & experience

ü  Provide presentation through electronic media and unlimited questions and answers

ü  Provide quizzes and share answers at the end of the course

ü  Provide certificates after completion of the course

v  Quality Assurance - 101

Provide comprehensive understanding, regulations and expectation from Quality Assurance department and its personnel. Share all aspect of QA department roles & responsibilities and how to deliver QA deliverables to manufacture high quality drugs.   

Learning Objectives & Areas Covered:

ü  Understanding QA roles & responsibilities

ü  How to develop QA departments and assign required responsibilities

ü  Understanding GxP (GMP, GCL & GLP) requirements and Compliance

ü  Understanding Quality Systems and Product Release requirements

ü  Understanding Policies, Directives, SOPs and Batch Records

ü  Understanding drugs manufacturing process from raw materials to finish product including products release

ü  Understanding drugs stability testing and annual product review requirements

ü  Understanding drugs approval process requirements & expectation

ü  Share US Pharmaceutical companies QA working experience & expertise

ü  Provide tools & techniques to be prepared for new job and/or enhance working knowledge & experience

ü  Provide presentation through electronic media and unlimited questions and answers

ü  Provide quizzes and share answers at the end of the course

ü  Provide certificates after completion of the course

v  Quality Assurance - 201

Provide knowledge, techniques and templates on how to develop and manage CAPA, Deviations and Change Control programs at the pharmaceuticals manufacturing companies.  Focus on Quality systems and its compliance. Prerequisite is Quality Assurance - 101.

Learning Objectives & Areas Covered:

ü  Understanding CAPA, Deviations and Change Control programs requirements & expectation

ü  Provide templates and techniques on how to develop and manage CAPA, Deviations and Change Control programs

ü  Benchmarking CAPA, Deviations and Change Control programs for the pharmaceuticals industries

ü  Understanding Management, Engineering, QA, QC, Validation and Regulatory departments’ responsibilities and expectation at CAPA, Deviations and Change Control programs.

ü  Understanding USFDA and others regulatory institutions requirements & expectation on CAPA, Deviations and Change Control programs

ü  Share US Pharmaceutical companies CAPA, Deviations and Change Control working experience & expertise

ü  Provide tools & techniques to be prepared for new job and/or enhance working knowledge & experience

ü  Provide presentation through electronic media and unlimited questions and answers

ü  Provide quizzes and share answers at the end of the course

ü  Provide certificates after completion of the course

v  Audit/Compliance - 101

Provide comprehensive understanding, regulations, expectation during internal and external audits for GMP Certifications and Drugs Pre-Approval Inspection.  Share all aspect of audits, how to handle it, what to do and don’t during the inspections.  Help to be ready for any audits, track 483s and complete opened corrective actions.

Learning Objectives & Areas Covered:

ü  Understanding GxP (GMP, GCP and GLP) compliance requirements

ü  Understanding and developing internal  and outside vendors audit programs

ü  Maintaining separation and cooperation between productions and quality auditors

ü  Understanding what to do and don’t during the inspections

ü  Opening CAPAs on significant issues

ü  Management, QA, QC, Validation, Regulatory Departments roles & responsibilities during the inspections

ü  Understanding USFDA and others regulatory institution and their requirements & expectation during the inspections

ü  Auditors qualifications and training

ü  Audit checklist and final reports

ü  Share US Pharmaceutical companies and USFDA audits experience & expertise

ü  Provide tools & techniques to be prepared for new job and/or enhance working knowledge & experience

ü  Provide presentation through electronic media and unlimited questions and answers

ü  Provide quizzes and share answers at the end of the course

ü  Provide certificates after completion of the course

v  GMP - 101

Provide comprehensive understanding, techniques, regulations, and expectation during pharmaceuticals GMP manufacturing process and how to implement good manufacturing practices (GMP) at the pharmaceutical companies.  Share what are the challenges and opportunities during pharmaceuticals GMP manufacturing activities.

Learning Objectives & Areas Covered:

ü  Understanding drugs GMP production personnel responsibilities & expectation

ü  Understanding drugs manufacturing process and documentation

ü  Understanding Batch records completion, sampling, instruments calibration, documents requirements

ü  Understanding Management, Manufacturing, Engineering, QA, QC, Validation, Regulatory Departments’ roles, responsibilities and expectation during drugs manufacturing process

ü  Understanding USFDA and others regulatory institutions  requirements & expectation

ü  Understanding drugs bulk & finish manufacturing, filling, packaging, labeling and shipping requirements and expectation

ü  Share US Pharmaceutical companies drugs manufacturing experience & expertise

ü  Provide tools & techniques to be prepared for new job and/or enhance working knowledge & experience

ü  Provide presentation through electronic media and unlimited questions and answers

ü  Provide quizzes and share answers at the end of the course

ü  Provide certificates after completion of the course

v  GMP - 201

Provide tools and techniques on how to develop manufacturing batch records, how to record manufacturing process information, collect in-process samples. Share drugs batch records templates and train how to initiate deviations and investigation during product failure, and how to follow GMP as per USFDA and other regulatory regulations & expectation.

Learning Objectives & Areas Covered:

ü  Understanding batch records requirements for bulk manufacturing, finish products, filling, packaging and labeling

ü  Provide templates and techniques on how to write & execute batch records for bulk manufacturing, finish products, filling, packaging and labeling

ü  Understanding how to initiate & complete manufacturing deviations and investigation

ü  Understanding Management, Engineering, QA, QC, Validation and Regulatory departments’ responsibilities and expectation during drugs manufacturing process

ü  Understanding USFDA and others regulatory institutions requirements & expectation on the Batch records

ü  Share US Pharmaceutical companies batch records development and execution experience & expertise

ü  Provide tools & techniques to be prepared for new job and/or enhance working knowledge & experience

ü  Provide presentation through electronic media and unlimited questions and answers

ü  Provide quizzes and share answers at the end of the course

ü  Provide certificates after completion of the course 

INSTRUCTOR PROFILE

Mr. M M Chowdhury, Chemical Engineer, PMP is an experienced Quality Assurance/ Validation Project Manager & Consultant/ Engineering & Validation Manager with over fourteen (14) years in the USA Pharmaceuticals, Medical & Biotech Industries. He managed and performed multiple equipment/system, utilities, facilities, computer, process and cleaning validation activities; and overseen Change Control, CAPA, Deviations, Calibration and Maintenance Programs, coordinated multiple USFDA and other regulatories’ inspections. 

He also have worked in the areas of Validation Project Management, Remediation Projects, GMP Production Supports, QA, Global Outsourcing, Change Control System, GxP Compliance, Engineering, Technical Supports (Deviations, Investigations & CAPAs), Manufacturing, Technology Transfer/Scale Up, Supplier/Vendors/Contract Manufacturers/QA Audits and Quality Control. 

He has been an employee and consultant for multiple world-class USA pharmaceutical companies including Pfizer, Aventis-Sanofi, Johnson & Johnson, Dow Chemical, Élan Pharmaceuticals, CB Fleet Lab, AVI BioPharma and Cody Laboratories. Currently he supports Sanofi Pharmaceuticals as Quality & Validation Project Manager and also the Founder & Senior Pharmaceuticals Consultant at Amreteck Pharma, based in Georgia, USA.