Overview: The presentation will provide an insight and guidance to managers with PV QA departments to implement a Remote Auditing program, and will focus on:
The presentation will provide an insight and guidance to managers with PV QA departments to implement a Remote Auditing program, and will focus on:
- Identifying candidates suitable for Remote Audits
- Designing a Remote Audit program
- Preparing and Conducting Remote Audits
Michael Ramcharan has over 25 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations since 1990. His auditing experience has involved conducting a wide variety of audits in GPVP, GCP and GCLP, globally. He has also hosted and supported various Regulatory Authority Inspections (eg; MHRA, EMA, Local EU) in the GCP and GPV space.
Michael's audit experience has also extended to successfully designing, implementing, and conducting Remote audits in the GPVP arena which has allowed companies to maintain strong oversight of their Local Operating Companies and Business Partners in countries where travel restrictions do not allow for on-site audit visits.
Michael has also assisted companies in managing their Pharmacovigilance QA audit programs adopting a risk-based approach to help identify and prioritise audits.
Michael has also been involved in the Training and Mentoring of auditors, providing bespoke training catered specifically to an individual’s development needs, and his varied experience has proved very valuable in this area.
Overview: Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs.
Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant, and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global commercialization strategies.
Parminder Kaur is a regulatory affairs expert and an EU QPPV having 19+ years of recognized global expertise in a broad range of therapy areas. She has also played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies.
In 2011, she led an IMI Project on combination therapy at EFPIA, in close collaboration with Research & Development Group (RDG) at European Commission. In March 2007, Mrs. Kaur had been selected by the European Federation of Pharmaceutical Industries and Association (EFPIA) for her global expertise and also had an honor to be the Scientific Representative from India for the year 2000-2001, duly sponsored by UNESCO.
Parminder had also been a speaker, panelist and Masterclass provider at various National and international Conferences. Parminder is the founder of RA&PV Consultancy, RegPak Biopharma Consulting based in Amsterdam.
Overview: Like any other Validation studies, Cleaning validation has been considered as a Generic version in the list of Validations.
Like any other Validation studies, Cleaning validation has been considered as a Generic version in the list of Validations. But is that true? We use different Acceptance Criteria for deciding effectiveness of Cleaning. But how can we fix, the correct approach, how should we design & perform the Cleaning validation studies. Are the AGE OLD Concepts, still stand Valid OR else the EXPECTATIONS of the Regulators have changed.
Cleaning Validation is not the baby of QA, but requires integrated efforts of all the functions. Do we feel that we are able to put all the threads together towards performing CV studies. I think - NO. We miss many things, which must be our FOCUS, while designing a Cleaning Validation Protocol. This is the age of RISK, and our Cleaning Validation should be based on the framework of RISKS involved.
Over the period there have been various advancements for evaluating effective cleaning. The current workshop addresses the Cleaning Validation study with a different insight and will definitely make you find that what we had been doing, requires more studies and we can make it a rugged integrated part of the process to ensure Quality, Safety & Efficacy of the Product. The purpose here is NOT to discuss a GENERIC Approach to Cleaning Validation, but to have an in-depth understanding of Cleaning validation and BREAK the thinking process to look it from different Perspective.
Mr. Vikram Kulshreshta Post Graduate in Microbiology with over 28 years of experience in Quality Assurance & Regulatory Affairs.
Companies worked in - Lupin, Cadila Pharma, Alembic, Amoli Organics, Claris Injectables (Now BAXTER), with Global presence.
Expert in "Designing & implementing the Quality Systems", Qualifications & Validations,Trouble-shooting & CAPA implementation and Regulatory Affairs.
Well versed with International cGMP regulations, e.g. USFDA, MHRA, TGA, ANVISA Brazil, MCC- South Africa, COFFPRIS-Mexico, WHO-Geneva (Prequalification program).
Has Registered many Drug Substances & Drug Product dossiers to US, Europe and other regions. Expert in handling Post DMF Approval changes.
Consultant & Auditor-
API & Formulation manufacturing companies for USFDA/EU Audit preparations, Helped the companies to get USFDA, EU & other Regulatory approvals.
Conducts Pre-inspections Gap analysis & compliance.
Handles USFDA Warning letters to ensure compliance as well as Post audit
observations, to comply with the CGMP, using a holistic & risk based approach.
Conducted Pre-USFDA Gap Analysis and ensured Compliance for Alkem laboratories (for
two Formulation manufacturing sites), Nectar Lifesciences (for their API & Injectable
Formulation manufacturing sites). Both the sites got USFDA approval.
Facility & Projects
Validations & Qualifications - Facility, Equipment, Utilities & Processes
Expert in implementation of Risk based approach in designing Quality Management
Systems, Processes and Validations.
Renovation of existing manufacturing facilities to make it Global Regulatory compliant
(USFDA, EU, MHRA, PICS etc.).
Software validation
Specialization
APIs (Sterile & Non sterile), Formulations (Parenterals & Solid/liquid
orals) manufacturing facilities
Quality Management Systems,
Validations & Qualifications
CAPA Management
Handling of Regulatory matters
Data Integrity
Trainings
Conducts Trainings as well as Interactive workshops in India and abroad on CGMP,
Validations & Qualifications, ICH (Quality series), Technology Transfer, QMS elements etc.
My Training workshops are attended by the seniors from all the big Pharma companies.
For example in India, the participants are from the companies like – Sanofi, Abbott,Lupin, Aurobindo, Glenmark, Hetero, Torrent, Sun Pharma, Biological Evans, Cadila etc.
Conducts In-house trainings for Employee for up-gradation of knowledge through real life examples using interactive sessions.
Conducts Training Sessions for students in Pharmacy colleges
Delivers session in Pharmexcil INDIA (Export Promotion Council of India).
Webinars in India & Europe on CGMP, Validations & Qualifications, ICH (Quality series), QMS.
Overview: The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.
The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.
Dr Flavio De Rosa founder of Paracelsus Science GmbH, has more than 30 years of drug development industry experience in all phases of drug development covering diverse therapeutic areas, including oncology, rheumatology and infectiology, and with diverse responsibilities - from drug safety analyses, to advising senior management to study design and conduct.
Academically trained (PhD, MSc. Diploma in Pharmaceutical Medicine) with extensive "hands on" experience in medium and large pharma companies and in a specialised CRO, Dr De Rosa has a broad knowledge of the industry and of medicine and experience working with Key Opinion Leaders. With considerable Clinical Scientist experience in the US, Europe and Australasia (Australia, Malaysia, Japan) he has successfully and consistently delivered complex projects and analyses within set timeframes, budgets and to a very high standard.
About Paracelsus Science GmbH;
Paracelsus Science was set up in 2017 to offer support to companies requiring senior specialised staff on a one-off, short- and medium-term basis.
