Pharmaceutical Water Systems

– Validation, Monitoring and Inspection Preparation

   16 – 17 MAY, 2019

 HYDERABAD, India

Pharmaceutical Water Systems are critical to routine manufacturing of product as well as for use within the cleanroom (Room Disinfection). Some water systems are also used to generate feed water which is critical to the manufacturing of product.

Difficulties and associated water failures and investigations, have led to several product manufacturing delays due to inability to use the affected water for the manufacturing of product as well as for their cleanroom operation. The cost associated with failure investigation, failed water system and impact to the manufacturer operation is high hence having a good knowledge of these requirements and how to apply it to new or existing water systems will benefit the attendee.


WHY YOU SHOULD ATTEND:

This seminar will help the attendee gain an understanding of the requirements of Pharmaceutical Water Systems per current USP <1213> Water for Pharmaceutical Purposes. This seminar will describe the different types of pharmaceutical water systems, the importance of Validation, Monitoring, design and routine testing.

This interactive workshop will also guide drug product manufacturers with a new or existing water system about the appropriate types of testing, frequency, as well as Water System Investigation.

WHO SHOULD ATTEND

    • Quality Assurance Personnel and Management
    • Quality Control Personnel and Management
    • Laboratory Managers
    • Testing Analysts and Technicians
    • Manufacturing Personnel and Management
    • Suppliers and Vendors of Pharmaceutical Water Systems
    • Validation Personnel and Management
  • Supplier Quality Assurance Personnel and Management
  • Regulatory Affairs Personnel and Management
  • Shipping and Receiving Personnel and Management
  • Facility and Maintenance Personnel and Management
  • Microbiologist Personnel and Management
  • Engineering Personnel and Management
  • Materials Management Personnel and Management

DAY 1 : (8.30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

– Regulations Guiding Pharmaceutical Water
– Current USP <1213> Pharmaceutical Water System
– Types and Uses of the Different Pharmaceutical Water Systems
– Planning the Design of a Pharmaceutical Water System
– Evaluating the Supplier or Vendor of the Pharmaceutical Water System
– What Makes Water Systems Have Microbial Quality Problems
– Successful Sanitization Approaches for Trouble-Free Water Quality
– Water System Validation by Logic
– Test Method Validation
– Special considerations for lab water systems
– Implementing Changes to a Validated System
– Reducing Water Microbial Excursions & Improving Investigations

DAY 2 : (9 AM – 5 PM)

Meet & Greet: 8.45 AM – 9 AM

– Routine Testing Programs for Pharmaceutical Water (Post Validation)
– Best Practices to consider when testing pharmaceutical Water
– Understanding and Controlling Endotoxin
– Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
– Issues with High Purity Water Systems
– Pharmaceutical Water Failure
– Water System Investigation “How-To” and Example Case Studies
– Water Testing Data Management
– What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues
– Review of Case Studies – FDA Recent Form 483 Applicable to Pharmaceutical Water

PRICING OPTIONS & REGISTRATION

Mercure Hyderabad KCP

Banjara Hills, Hyderabad, Telangana

May 16 – 17, 2019

 





 





Kalpesh Kumar Vaghela

Validation Expert

Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.

Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry. He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.

Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.

G. Sundar

PharmQA Consultant

Mr. Sundar Ganesan is a quality practitioner with 24 + years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA and Japan guidelines. He assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems so that the company can succeed. Mr. Ganesan currently working as Director-Consultant at PharmQA Compliance services an independent consultant firm partners with US and Europe.

Brian G. Nadel

ex-FDA Official

Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA’s Centre for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.

Mr. Nadel holds a Bachelors degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.

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Terms & Conditions to Register for the Seminar

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in

Payment Policy:

Payment is required to be made at least 10 business days prior to the date of the conference.

To make payment by Wire Transfer / Cheque / Credit or Debit Cards, kindly call our Customer Support to assist you with completing your registration. Payments to be made in full.

Customer Support: +91-80-4170-0521
Email: info@compliancetrainings.in

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 3 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

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Written cancellations through email (from the person who has registered for this conference) received at least 12 business days prior to the start date of the event will receive a refund – minus a Rs. 3000 administration fee. No cancellations will be accepted – nor refunds issued – within 12 business days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees (Rs. 3000) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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