Anushri Global Pharma Consultants

Transcription

1 Anushri Global Pharma Consultants Your Knowledge Partner In Training, Consulting & Placement Anushri Global Pharma Consultants A Catalyst to sustainable growth Page 1 of 9

2 About Us Training is important vertical of ANUSHRI GLOBAL PHARMA CONSULTANTS is based at Indore, a commercial Capital of Madhya Pradesh. We started with a vision of meeting the considerable requirement for training people, which drives the information and knowledge-driven Indian economy. It is known in pharmaceutical industries for a high quality of training managed professionally. Our training programs are comprehensive, interactive, involves case studies,practice sessions etc. They are easy to understand and designed to enhance knowledge and to keep pace with continually changing regulations and quality standards. Your needs and expectations through training are considered during program design. These training program helps to build up confidence, make your employees more efficient. We can help you to improve your business performance and achieve your business goals through training targeted at the specific competence needs of your organization. Before delivering training we understand your needs and expectations through training need analysis. We design the training deliverables in order to help trainees to get the knowledge and skills necessary to improve their performance, leading to improvement in your business. No matter where you are, no matter how big or small your company and how unique your request, we will always find a solution tailored to your needs. Page 2 of 9

3 Why Choose Us? Flexible approach Long term partnership Customized Solutions People development and consulting Quality based working methods Rich Experience in Training Faculties from reputed pharmaceutical industries Anushri Global Pharma Consultants Training Services List of Training Programs dura ATV01 Quality by Design ATV02 Validation and Qualification 1 day ATV03 Analytical method validation 1 day ATV04 Cleaning validation 1 day ATV05 Process validation 1 day ATG01 Good Manufacturing Practices 2 day ATG02 Good Laboratory Practices ATG03 Good Documentation Practices 1 day ATG04 Good Distribution Practices 1 day Page 3 of 9

4 ATG05 Good Storage Practices 1 day ATS01 Clean room behaviour 1 day ATS02 Sterility Assurance / Aseptic Processing 2 day ATQ01 Cross contamination controls and prevention 1 day ATQ02 Quality Risk Assessment 1 day ATQ03 Regulatory / Customer GMP audit Management ATQ04 Data Integrity 1 day ATQ05 21 CFR Part 11 compliance 1 day ATQ06 Out of Specification Investigation ATQ07 Quality Management System (ICH Q10) 1 day 1 day Page 4 of 9

5 ATR01 ATR02 Preparation of Drug Master File/ANDA Preparation of Certificate of Suitability Dossier 1 day ATC01 Awareness on ISO 9001 : 2015 ATC02 Awareness on ISO : 2015 ATC03 Awareness on ISO 45001:2018 ATC04 Awareness on ISO : 2018 ATC05 Awareness on ISO/IEC 17025:2017 ATC06 Responsible Care ATH01 HAZOP studies 1 day ATH02 Hazard Analysis and Risk Assessment Client can suggest topics for training based on their need 1 day Page 5 of 9

6 Pharma Consultancy Services Anushri Global Pharma Consultants provides the following services to pharmaceutical industries worldwide. GMP Audits/GAP analysis to evaluate compliance level with respect to Schedule M, WHO, EU, USFDA and other Regulatory agencies. Helping Industries to develop and maintain quality system as per cgmp. Assisting Industries to get approvals from EDQM, US FDA, WHO, MHRA, ANVISA, TGA, Indian FDA and Other Regulatory Agencies We assist Industries to make them ready and pass their customer quality audits. Identification and evaluation of Contract Manufacturing Sites on your behalf Documentation of R & D, CRO as per GLP Preparation and submission of Drug Master Files, ANDA, Certificate of Suitability and other regulatory dossier. Manufacturing, quality control, microbiology lab, warehouse and R & D facility designing. Pharma Placement Services Placement Services is another vertical of ANUSHRI GLOBAL PHARMA CONSULTANTS. Provides faster and quality placement services across all pharma and related industries. We hire for our pharma clients not only at a PAN India level but across the Globe. Our niche recruitment areas are pharma and related sectors. We provides recruitment at senior, middle, junior and fresher level based on client need. Page 6 of 9

7 Profile of Faculty and Consultant Mr. Anil Birari has huge experience and serving pharmaceutical industries since last 25 years. Worked with repute d pharmaceutical companies including R & D of India at senior position like Quality Head, Site Head, General Manager. Has Expertise in the field of quality assurance, quality control, regulatory affairs, and pharma plant operations, regulatory audit compliances and pharmaceutical regulations with respect to formulations ( OSD, Injectable, Topical ) and API (Sterile, non-sterile, oncology) The area of expertise covers quality management system as per cgmp, GLP. GXP, GDP (Good distribution practices) and Schedule M, USFDA, EDQM, EMA, ANVISA, WHO, PMDA, Page 7 of 9

8 TGA, MHRA, MCC, Health Canada and other. Thorough understanding of various guidelines like ICH, US FDA, PDA, PICS, Orange Guide, 21 CFR Part 11, GAMP and huge practical experience in implementation of quality system from scratch and building it up to the level expected to get regulatory approvals from US FDA, EU, MHRA, WHO, TGA, ANVISA and other. Has tremendous exposure in developing/review technical documents required for filing various regulatory dossiers including Drug Master Files, ANDA, and Certificate of suitability etc. as per the current applicable Rules, Regulations and Guidelines. Master in equipment qualification methods (URS, FAT, SAT, IQ, OQ, PQ) of bulk drug and formulation manufacturing equipment meeting internationally acceptable standard. Analytical method validation, process validation, cleaning validation, software validation etc. Qualification of Utilities like Water for Injection, Purified water, DM water generation and distribution system; HVAC/FDV system, Compressed air system etc. Analyst qualification. Thorough understanding and working knowledge of sterility assurance/aseptic processing /procedures, media fill studies etc. Good working knowledge of OOS, OOT, OOC, unplanned deviation, market complaint, laboratory incidence investigation. Development related activities like Quality by design, Quality Risk Assessment at R & D and plant level. Impurity profiling. Forced degradation studies. Defining specification and test method for final product, intermediate, In-process control. Working and Reference standard qualification. Impurity carryover studies. Technology transfer document review, transfer of technology from R & D to plant for regulated markets. Preparation / Review of Technology transfer report, Stability studies of drug substance and drug products. Page 8 of 9

9 Hands-on designing the API (Non Sterile, Sterile, Oncology), Formulation (Oral / Injectable) manufacturing facility, Clean room (Class A to Class D, control unclassified). Warehouse for Raw/packing materials storage and dispensing; Bulk solvent storage facility, quality control and microbiology laboratory (Classified) R & D laboratories meeting cgmp, GLP standards. Working knowledge of the procedure, roadmap to be followed to obtain approvals / certifications from regulatory agencies like US FDA, ANVISA, EU, TGA, Japan, MHRA, WHO etc. Other certifications like ISO 9001, ISO 14001, BIS OHSAS 18001, and Responsible Care. Handled several international Regulatory Inspections and hundreds of pharmaceutical customer quality audits. Excellent understanding and working experience of API, Intermediate and Formulation CRAMS business model. Hands-on Pharma plant operations under strict EHS and Quality Standards meeting business goals. Trained under retired US FDA investigator for handling regulatory inspections. The Accomplishments Under team leadership obtained various regulatory approvals like US FDA, ANVISA, WHO and other without any major observations / 483 for drug substance and drug product. Under team leadership obtained certifications ISO 9001, ISO 14001, BS OHSAS 18001, Responsible Care, ISO/IEC Handled green filed API and Formulation facility construction projects; ensured the facility, equipment design is meeting process, operational requirements and cgmp, EHS standards as per domestic and International Rule and Regulation. Page 9 of 9

10 Helped industries to bring new facility (Manufacturing, Quality control lab, Microbiology lab, Warehouse, R & D, Utility) into operation under cgmp/glp conditions meeting domestic and international Regulatory norms. Performed several hundred validations and qualification of quality control, microbiology laboratory, formulation and API manufacturing equipment, Software, Utilities, HVAC, water generation and distribution system in a new and existing set up built to produce and supply of API and Formulation products to regulated and semi-regulated markets. Implemented cgmp, GLP system from scratch at the pharmaceutical manufacturing facilities, R & D and developed to the level to get regulatory approvals like ANVISA, US FDA, WHO and other. Handled several Process and analytical technology transfers from R & D to Plant and from one plant to other contract sites to produce exhibit batches for the regulated market like the US. Reviewed and filed several regulatory dossiers like DMF, ANDA, Certificate of suitability etc. Awarded by the companies for excellent work of filing regulatory dossiers like DMF, Certificate of suitability and for sorting out regulatory issues in short period. Led the team multiple times and obtained cgmp approval from various international pharmaceutical customers like Pfizer, Novartis and many other. Was elected and awarded by R & D staff as most respected/influential person at R & D Centre. Imparted several trainings to pharma professionals on cgmp, GLP, Validation, qualification, data reliability and integrity, dossier preparations and submission etc. Under CRAMS business executed successfully several Quality Risk Assessment studies and Analytical method Page 10 of 9

11 validations, impurity carryover studies for regulatory submission; orders worth of million dollars. Spearheaded overall pharma plant operations and under leadership turnaround site revenue from INR zero to 200 crores/annum under CRAMS business model. Contact us For more details about our products and services visit our visit our website : anushrigpc.com You may write to us for any assistance re at agpharmaconsultants@gmail.com Mobile : Address ANUSHRI GLOBAL PHARMA CONSULTANTS Villa No. 709, Omaxe City -1 Near The Grand Bhagawati Hotel Bypass Road, Indore, Madhya Pradesh, India Pin : Branch Office Mumbai Page 11 of 9

12 Flat No. 301 Datta wadi, Near Kaman, Shrikrupa Apartment, Badalapur East Mumbai, Pin : Page 12 of 9