Spectrum Raaj GPRAC

12/04/2022

Greetings from Raaj GPRAC & Raaj Pharma eLearning!

ONLINE Training Anytime from Anywhere!!
Raaj GPRAC's most awaited trainings on Internal/Lead Auditor, MDD to MDR and MDSAP for May 2022 - block your calendar

1. MDD to MDR Implementation
Date: 7th and 8th May 2022
Time: 5:30pm to 9:00pm
Fees: Rs.10000+1180 (GST)=11800/-

2. Internal Auditor ISO 13485:2016 (QMS)
Date: 14th -15th May 2022
Time: 5:30pm to 9:00pm
Fees: Rs.10000+1180 (GST)=11800/-


3. MDSAP Webinar
Date: 21st -22nd May 2022
Time: 5:30pm to 9:00pm
Fees: Rs.10000+1180 (GST)=11800/-

WHO CAN ATTEND?
Pharma & Medical Device Industry Professionals, Biomedical Engineers, Consultants, Regulatory Professionals, Student and who are willing to make career MEDICAL DEVICE industry.


Mode: Zoom Meeting link shared via Email and WhatsApp
Requirements: Laptop, iPad or Android Phone with Good Internet Connection

For further details, please contact:
Contact No: 9819125208, 9821144706
Email: [email protected], [email protected], [email protected]
Visit our website: https://lnkd.in/fkFqfeF

To Register for the webinar, kindly fill the google form:
https://lnkd.in/g43Q5TE4

12/04/2022

Greetings from Raaj GPRAC & Raaj Pharma eLearning!

ONLINE Training Anytime from Anywhere!!
Raaj GPRAC's most awaited trainings on Internal/Lead Auditor, MDD to MDR and MDSAP for May 2022 - block your calendar

1. MDD to MDR Implementation
Date: 7th and 8th May 2022
Time: 5:30pm to 9:00pm
Fees: Rs.10000+1180 (GST)=11800/-

2. Internal Auditor ISO 13485:2016 (QMS)
Date: 14th -15th May 2022
Time: 5:30pm to 9:00pm
Fees: Rs.10000+1180 (GST)=11800/-


3. MDSAP Webinar
Date: 21st -22nd May 2022
Time: 5:30pm to 9:00pm
Fees: Rs.10000+1180 (GST)=11800/-

WHO CAN ATTEND?
Pharma & Medical Device Industry Professionals, Biomedical Engineers, Consultants, Regulatory Professionals, Student and who are willing to make career MEDICAL DEVICE industry.


Mode: Zoom Meeting link shared via Email and WhatsApp
Requirements: Laptop, iPad or Android Phone with Good Internet Connection

For further details, please contact:
Contact No: 9819125208, 9821144706
Email: [email protected], [email protected], [email protected]
Visit our website: https://lnkd.in/fkFqfeF

To Register for the webinar, kindly fill the google form:
https://lnkd.in/g43Q5TE4

07/05/2021

04/05/2019

Hurry UP. Last few seats are left for Practical Training into eCTD submissions to USA & Europe at Raaj GPRAC training center on 9-10th May2019.
M-98219125208/ 9821144706,
Email- [email protected], [email protected]

13/02/2019

Greetings from RAAJ GPRAC PVT. LTD.

We are pleased to invite you for our next important seminar on Data integrity, CSV. Kindly book your seats at the earliest to avail early bird discounts.

2 Days Seminar on Computer System Validation [CSV] as per 21CFRpart11, EU Annex-11, PICs, GAMP-5, DATE- 15-16th MARCH 2019

Data Integrity a Top Concern for Pharma, Biotech Manufacturers, CRO, BPO, IT Etc.
In the past few years, several FDA warning letters (483s) have been issued for data integrity deficiencies in the pharmaceutical industry. In 2016, more than 50 percent of MHRA warning letters involved data integrity lapses for computerized systems compared to the previous year. Inspectors are actively trained in data integrity requirements, and strongly enforce them for falsified batch records or discharging of raw data. Understanding recent standards, guides, and regulations pertaining to data integrity is essential to becoming compliant. Relevant documents include 21 CFR Part 11, MHRA: GxP, EU GMP Annex 1, the FDA Data Integrity and Compliance with cGMP, and the WHO Good Data and Record Management Practices. Inherent to data integrity compliance is the goal of increasing product quality, regulator confidence, brand reputation, and process control, while reducing product defects and costs. This applies to multiple areas of the pharmaceutical industry, including manufacturers of finished drug products for clinical trials, bioequivalence studies and commercial distribution, laboratories, contract manufacturing, suppliers, etc.

Data integrity is an old concept made essential in today’s digital age, and means data that is accurate, complete, and repeatable, which in turn ensures the product’s quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters. The importance of record-keeping in drug manufacturing can be seen as far back as 1938, when the Federal Food, Drug, and Cosmetic (FDC) Act required the safety of new drugs be documented before being sold to the public, with similar regulations instigated in Europe and Japan throughout the 20th century.1
Production systems have large, inherent operational risks and are difficult to validate. Instead of exclusively reacting to public health disasters, preventative measures — such as the requirement for proof of claims — are taken to lower their likelihood and instill confidence in manufacturers.

We at RAAJ GPRAC PVT. LTD have given some serious thought to the issues and challenges pertinent to the CSV and are organizing a SEMINAR on “CSV as per 21CFRpart11, EU-Annexx11, PICs, GAMP-5”. This seminar will be held from 14th & 15th March 2019 at RAAJ GPRAC TRAINING CENTRE. MUMBAI-THANE.

LEARNING OBJECTIVES:
-DATA INTEGRITY ISSUES
-RISK ASSESSMENTS
-CSV AS PER 21 CFR PART 11, EU-ANNEX-11,
-GAMP-5 CATEGORIES & V-MODEL
-CURRENT ISSUES & INDUSTRY TREND
-DOCUMENTATION REQUIRED FOR COMPLIANCE
-SOP, URS, FRS, BCP etc.
-CASE STUDIES
-Brainstrorming & Many more

FEES 15000/- P.P for 2 days [INCLUDES TRAINING KIT, 2 days Lunch, Snacks, Tea, Certificate]
5% Discount for 3 participants
10% Discounts for 5 & more participants.

Thanks and looking forward to your presence
Best regards,
Rajashri ojha
Founder & MD,

2 Todays workshop in Computer system validation as per 21CFR Part 11, Annex-11 and GAMP-5

18/01/2019

We are looking for TRAINERS in cGMP, GLP, GDP , CSV and Regulatory Affairs in Pharma industry.

18/01/2019

Dear Sir/Madam,

Greetings from Raaj GPRAC & Raaj PharmaeLearning! Wishing You a a HAPPY NEW YEAR-2019

BATCH STARTS FROM 6th JANUARY 2019 in GLOBAL RA, QA-QM & RA[formulations] for CLASS ROOM WEEKEND TRAINING. Hurry up!! as ONLY FEW SEATS ARE LEFT.

DISTANCE LEARNING ADMISSION IS OPEN FOR 365 x 7 days

ABOUT US:
RAAJ GPRAC was founded by Rajashri Survase Ojha in 2010 and have been successfully completed 9 years. After 27 years of industrial experience from Sandoz, Ciba-Gegy, Local FDA, Glenmark, GSK-TCS, Novartis, Famycare, Cognizant, Spectrum Pharmatech, Synergy UAE, Raaj GPRAC has completed 9 successful years as a Regulatory CONSULTANT, TRAINER & AUDITORS. We do provide GMP, Regulatory services and Pharma Training programs across the world through CLASSROOM [CL] Training & DISTANCE learning [DL] education.

Our courses are recognized by Government and NSDC accredited through LSSSDC[Life Science Sectors Skill Development Council]. Our institute is ISO 29990-2010 certified which provides all Advanced knowledge to Fresher’s skilling and Up-skilling for working professionals from Pharma, Biotech, industries and CRO, BPO, KPO etc to BOOST their career. All trained candidates get jobs very easily and prosper into their career very fast. We offer courses as CLASSROOM LEARNING (CL) on Sat/Sunday or through DISTANCE LEARNING (DL) programs. We have trained more than 8500 candidates till date on various subjects across the GLOBE.
Our team Comprises of Auditors, Scientist, Analyst, GMP, RA professional, RAPS qualified professional and Experts in respective domain with rich hands on experience of, R & D, Quality Compliance, Validations[Analytical, Cleaning, Equipment, Computer system validations], and Regulatory affairs with over 25+ years of very versatile experience in pharmaceutical industry.
We have Trained more than 8500 candidates till now on various aspects of GLOBAL Regulatory Affairs, R & D, [Formulation, Analytical], Quality, Compliance, QMS, GMP, GLP, GDP, ICH topics, 21CFR Parts, CSV , GAMP, CDER, Regulatory filings in CTD/eCTD/ACTD/NeeS formats & obtaining marketing approvals worldwide. Supported in Technology transfer and product Life Cycle Management (Pharmaco-vigilance) etc.
Please find below attached Admission Form, Syllabus along with fees structure for your quick reference. We shall send Registration number & Welcome kit after the payment of fees, filled Admission form along with your Degree certificate, Address proof[Adhar Card] and Photo.

Our courses are designed by senior professionals who have 25 to 30 years of industrial experience and we continuously upgrade our notes and study materials based on current industrial norms and rules and regulations.

Please send us filled form along with your Adhar Card, Degree certificate, CV and one photo. You can send everything via email scanned copies and you can pay the fees through NEFT transfer into our bank accounts.
You may select single course or multiple courses in combination. Also payments can be done by Cash to save GST.

Please let us know whether you are interested into CLASSROOM [CL] or DISTANCE [DL] learning courses? As the fees is different for the CL & DL and the fees to be paid through NEFT transfer based on your selection of course. You may select 2 to more courses or COMBO-courses to get discount. Bank details are as given follows....Once the payment is done, your study material will be sent at your postal address and video-Audio lectures and other PPT, guidance will be available for you. We help you for your RESUME development, Interview techniques, How to crack interview with difficult questions etc.

18/01/2019

AVAIL- 50% DISCOUNTS FOR RAAJ GPRAC STUDENTS, TEACHERS AND ACADEMIC STAFF & PROFESSIONALS.

How to become an effective Trainer?
One day workshop on ‘TRAIN THE TRAINER’ on 2nd February 2019 at Raaj GPRAC, Mumbai-Thane.


Dear Sir/Madam,

Greetings from Raaj GPRAC Pvt. Ltd.

Please find attached details of “Train the Trainer’’ an advanced workshop to be held on 2nd Feb 2019 at Raaj GPRAC Training center. Please book your seat well in advance for any one day of workshop.

Know about your Trainers;

Ms. Rajashri Ojha is a world renowned GMP & Regulatory Consultant, Auditor & Trainer with more than 27 years of experience across USA, EMEA and APAC region. She was the Global Head-RA-CMC for Novartis, Worked for Sandoz-Ciba-Geigy for more than 10.5 years, Cognizant, GSK-TCS, Famycare-Mylan, Local FDA, Unichem, Synergy Pharma, Spectrum & others. Rajashri is the founder and Director in Raaj GPRAC [‘Raaj Global Pharma Regulatory Affairs Consultants] Thane-Mumbai since 2010 and completed 8.5 successful years as women Entrepreneurship. Raaj GPRAC is an ISO29990-2010 certified institute.

She was awarded for ‘’ Women's leadership India Awards in Pharma Coaching ‘ by iiGlobal in February2017.

Ms. Preeti Naik- She brings more than 15 years of Corporate experience. This experience has given her foundation to her people skills since her role involved in Talent Management, Learning and Development and Talent Performance Management. Preeti has worked with organizations like DHL, Deloitte Consulting and Tata AIG. Preeti is has done her PGCHRM from XLRI and is a commerce graduate by qualification. She is an accredited NLP practitioners certification from Richard Bandler- Alpha stars. Other certifications include Deloitte Faculty Experience Certification for ILT, Simulation & Virtual Training, Gallup Strengths finder, International Training and Teaching program (1104)-UK, and Personal Profile Analysis.

She believes in creating lasting relationships through the value add she can provide. She has trained and written content. ‘Genius is one percent inspiration and ninety nine percent perspiration’ is her mantra for the success of her training sessions

Over the past years, she has worked with multiple firms in Services and Consulting with her last stint in a global MNC leading the Talent management and Talent Development. This unique blend of experiences has given her a broader perspective and a good understanding of the Human Resources sector.



In this Seminar, we shall be mainly focusing on the key challenges & strategies of Effective Trainings such as:

q The Trainer in You!
q The role of a trainer?
q The knowledge you need to be successful?
q What skills do you need?
q What attitude do you need?
q What interests the audience?
q Being a Star Trainer
q Target audience
q Who are they? , What are their roles?
q What is their present knowledge/skill level?
q Have they undergone similar programmes?
q Analyze the Environment
q (W)rite the Content
q How do Adults Learn, Training Methodologies
q Brainstorming, Case Study, Discussion, Game, Role Plays
q Spoken Language, Use simple language.
q Use transitional words and phrases.
q Avoid the use of jargons and acronyms.
q Repeat terms, Do’s and Don’t
q Communicating Eye-to-Eye, Using Body Energy
q Positive Personal Signals, Negative Personal Signals
q Managing Group Dynamics
q Difficult Audience, Anticipate Questions, Handling Questions
q Structure the Q&A Interaction
q Answering Questions
q Dealing with Nervous Energy, Dealing with Nervousness
q Specify the Purpose
q Review, Summary, The feedback Sandwich
q Secret of Success
q Shine With Confidence ….
q Effective Visuals, Execute with Confidence
q Rehearse
q Enjoy your journey to an effective trainer …

And many more....

We would be conducting a practical and brainstorming session wherein you would be able to analyze your own gap in ‘ Train the Trainer’.

We firmly believe this would be a great workshop for your organization as to gain insights, plan your Leadership Development strategies & learn some of the best practices adopted by world leaders to substantially optimize and leverage your organization's Effectiveness & Corporate Image.

A good trainer should have thorough conception of the subject he/she is teaching. Communication between the speaker and the audience should be very clear. He / She should have knowledge of practical /industrial base/ down to the grass root. They should not be a mute speaker just to say do this, do that but capable to guide the trainees. The trainer is called a Guru and hence he should understand the type of shisya he/she is having and be able to train them with zeal. Learn the training schedule with an honest intention that both trainees and organization benefits

NOTE: To confirm the participation please send us the duly filled authorized registration form attached separately

Fees = INR 5499/- per participant. Do not hesitate to ask for Group discounts for more than 3 to 5 participants.

Looking forward for you & your team to be part of this Exclusive Workshop.


Best regards,
Rajashri Ojha
Founder & MD,
RAAJ GPRAC PVT. LTD, Skype-rajashri.ojha

Unit no. 144 & 145 First Floor,
Lodha Boulevard Commercial Premises,
Nashik Highway Road, Majiwada,
Thane(West)Pin:400601 , Maharashtra, India.
M 9819125208, 9821144706,
Website: www.raajpharmaelearning.com
Email: [email protected],

25/09/2017

Dear All, Admission open for October-2017 batches into Global RA, QA-Qm, Hands on CTD, eCTD, ACTD, NeeS submissions, Pharmacovigilance and others.

Please contacts us at [email protected], [email protected], Call us at 9819125208/9821144706

Visit our website at www.raajpharmaelearning.com

02/05/2017

Hurry Up, Last few days left for admission in Global RA, CTD-eCTD, QA-Qm, PV and others. Contact at 9819125208/9821144706, [email protected], [email protected]