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Global Regulatory Affairs Training

Best Institute for learn exert level Online Global Regulatory Affairs By Experts, Learn Global Regulatory Affairs Certification Training with Course Material, Tutorial Videos, Attend Demo for free & you will find SpiritSofts is the best institute within reasonable fee, Job Support

Spiritsofts is the best Training Institutes to expand your skills and knowledge. We Provides the best learning Environment. Obtain all the training by our expert professional which is having working experience from Top IT companies.The Training in is every thing we explained based on real time scenarios, it works which we do in companies.

Experts Training sessions will absolutely help you to get in-depth knowledge on the subject.

Key FeaturesCourse ContentFAQs
 40 hours of Instructor Training Classes                            24/7 Support

 Lifetime Access to Recorded Sessions                              Practical Approach

 Real World use cases and Scenarios                                 Expert & Certified Trainers

 

Global Regulatory Affairs Training Course Content

  • Provide regulatory strategy in order to achieve best preparation and approval time for regulatory dossiers (Brazil, Costa Rica, Egypt, Guatemala, Indonesia, Iraq, Ivory coast, Jamaica, Kenya, Malaysia, Mexico, Myanmar, Nepal, Nigeria, Pakistan, Peru, Philippines, Russia, Sri Lanka, Sudan, Syria, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkmenistan, Turkey, Ukraine and Venezuela).
  • Dossier submission as per eCTD/CTD/ACTD/NeeS submission compilations
  • Preparation of dossiers as per ANDA
  • Preparation of documents to import cosmetics
  • Preparation and review of Product summary file (PSF) to WHO for the vaccines DTPwH-HIB, DTPwH, Tetanus Toxoid and Hepatitis-B vaccines as a part of prequalification to WHO.
  • Preparation and review of PSF reassessment to WHO.
  • Preparation of dossiers for Diagnostic kits
  • Knowledge about GLP, GMP and GCP
  • Dossier preparation for Australia as per TGA guidelines
  • Dossiers preparation for Tables, Capsules, Liquids, Ointments and therapeutics
  • Dossiers preparation as per Common technical document (CTD) and ACTD.
    Module I
    Module II
    Module III
    Module IV
    Module V
  • Determine, evaluate and summarize data requirements for submissions and change controls to ensure regulatory needs.
    Annual post approval changes notification to WHO.
    Post approval changes notifying to other countries as per the guidelines.
    Change control review and notifying to DCG(I) as a part of post approval changes if any.
    Post approval changes submissions to DCGI as per CDSCO Guidelines.
    Level I – Supplements (Major Quality Change)
    Level II – Notifiable changes (Moderate Quality change)
    Level III – Annual Notification (Minor Quality change)
  • Prepare responses to Deficiencies & Queries from regulatory authorities.
    Keep abreast of changes to relevant regulations, policies, guidelines (FDA & ICH) training to internal/external stakeholders
  • Extensive experience in handling regulatory requirements through the product life cycle both in preapproval as well as post approval phases
  • Coordination with auditors for the execution of the audit and provide necessary documents
  • DCA/DCGI related works (documents submission for WHO – GMP certificate, Certificate of pharmaceutical product (COPP), import license, Free sale certificate, and for other country specific requirements.
  • Review of country specific regulations and interpretation of guidelines to provide required data for submission
  • Query response subsequent to submission of dossier
  • Country specific Art work preparation and review
  • Regulatory follow up with agents for faster registration
Who Are The Trainers?
Our trainers have relevant experience in implementing real-time solutions on different queries related to different topics. Spiritsofts verifies their technical background and expertise.
What If I Miss A Class?
We record each LIVE class session you undergo through and we will share the recordings of each session/class.
How Will I Execute The Practical?
Trainer will provide the Environment/Server Access to the students and we ensure practical real-time experience and training by providing all the utilities required for the in-depth understanding of the course.
If I Cancel My Enrollment, Will I Get The Refund?
If you are enrolled in classes and/or have paid fees, but want to cancel the registration for certain reason, it can be attained within 48 hours of initial registration. Please make a note that refunds will be processed within 30 days of prior request.
Will I Be Working On A Project?
The Training itself is Real-time Project Oriented.
Are These Classes Conducted Via Live Online Streaming?
Yes. All the training sessions are LIVE Online Streaming using either through WebEx or GoToMeeting, thus promoting one-on-one trainer student Interaction.

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Is There Any Offer / Discount I Can Avail?
There are some Group discounts available if the participants are more than 2.
Who Are Our Customers?
As we are one of the leading providers of Live Instructor LED training, We have customers from USA, UK, Canada, Australia, UAE, Qatar, NZ, Singapore, Malaysia, Sydney, France, Finland, Sweden, Spain, Russia Moscow, Denmark, London, England, South Africa, Switzerland, Kenya, Philippines, Japan, Indonesia, Pakistan, Saudi Arabia,  Qatar, Kuwait, Germany, Frankfurt Berlin Munich, Poland, Belarus, Belgium Brussels Netherlands Amsterdam, India and other parts of the world.

We are located in USA. Offering Online Training in Cities like New York, New jersey, Dallas, Seattle, Baltimore, Tempe, Chandler, Scottsdale, Peoria, Honolulu, Columbus, Raleigh, Nashville, Plano, Toronto, Montreal, Calgary, Edmonton, Saint John, Vancouver, Richmond, Mississauga, Saskatoon, Kingston, Kelowna, Houston, Minneapolis, Los Angeles, San Francisco, San Jose, San Diego, Washington DC, Chicago, Philadelphia, St. Louis, Edison, Jacksonville, Towson, Salt Lake City, Davidson, Murfreesboro, Atlanta, Alexandria, Sunnyvale, Santa Clara, Carlsbad, San Marcos, Franklin, Tacoma, California, Bellevue, Austin, Charlotte, Garland, Raleigh-Cary, Boston, Orlando, Fort Lauderdale, Miami, Gilbert.

Hyderabad (Ameerpet), Kukatpally, Vizag, Nellore, Lucknow, Coimbatore, Marathahalli, Electronic city , Silk board, Kakinada, Goa, Vijayawada, Bangalore, Noida, Chennai, Kolkata, Pune, Whitefield, Mumbai, Delhi NCR, Dubai, Doha, Melbourne, Brisbane, Perth, Wellington, Leeds, Manchester, Liverpool, Ireland Dublin, Oxford, Cambridge, Brighton, Cardiff, Bristol, Lithuania,  Latvia, Italy, San Marion, China Beijing, Auckland etc…

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