Online Safety Community

Pharmaceutical cGMP, Data Integrity and FDA Inspections – Current Challenges and Preparations

Event Details

Pharmaceutical cGMP, Data Integrity and FDA Inspections – Current Challenges and Preparations

Time: September 29, 2016 at 1pm to September 30, 2016 at 2pm
Location: Compliance Trainings
Street: Mumbai
City/Town: Mumbai
Website or Map: https://www.google.com/maps?l…
Phone: 080-4170-0521
Event Type: seminar
Organized By: complianceTrainings
Latest Activity: Aug 1, 2016

Export to Outlook or iCal (.ics)

Event Description

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

For more information click below link

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

Comment Wall

Comment

RSVP for Pharmaceutical cGMP, Data Integrity and FDA Inspections – Current Challenges and Preparations to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Training Doyens posted events
yesterday
Soujanya Naganuri posted a discussion

Flow of SAP MM and SUS Portal

SAP Material Management (MM) and SAP Supplier Self Service (SUS) and some customizable features of SAP SUS.In the Plan-Driven Procurement with Supplier Integration scenario the SAP SUS is installed and configured with SAP MM/SRM. Technically, in a classic scenario SAP SUS maybe connected with one or more MM and/or SRM back-end systems.PO is sent to SAP SUS system, in which supplier can perform the follow-on procurement process, i.e. PO response, ASN, GR response and invoice response.SAP…See More
Thursday
John Robinson posted blog posts
Thursday
Emma Miah posted a blog post

Latest Men’s Fashion Trends For Winter

Most people will agree that fashion trends use to fade, but the style is the one thing that is eternal. So, it’s always suggested that you should only follow the fashion trends that actually suits your personality. Winter is coming now it’s time to…See More
Thursday

Forum

Flow of SAP MM and SUS Portal

SAP Material Management (MM) and SAP Supplier Self Service (SUS) and some customizable features of SAP SUS.In the Plan-Driven Procurement with Supplier Integration scenario the SAP SUS is installed…Continue

Tags: sapmmcourse, sapmmonline, sapmm

Started by Soujanya Naganuri on Thursday.

PEGA Axis error: Parser already accessed

We have a PEGA frontend, from in which we're keying in double byte characters like japanese and being send to allotted java webservice through axis. this is working best when we ship singlebyte…Continue

Tags: pega_training, pega_online, pega

Started by Soujanya Naganuri Dec 6.

VMware player error on install vmware tools.

 I've installed the last version of VMware player (4.0.2) and created a virtual machine with ubuntu 10.04. However, some operations with …Continue

Tags: training, online, vmware

Started by emmablisa Dec 1.

All About QlikView

QlikViewQlik relies on sophisticated analytics that enables data discovery using an in-memory engine to analyze data for patterns not visible via SQL data structures or queries. The company’s two…Continue

Tags: Safety, Qlikview

Started by nicolewells Nov 25.

Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe Nov 16.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service