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21 CFR Part 11 and Risk Assessment

– Avoid Warning Letters and Reduce Costs

July 25 – 26, 2019

Ahmedabad, GJ, India

This 2-day Seminar on 21 CFR Part 11 and Risk Assessment will help you get completely familiar with the FDA – compliant implementation of 21 CFR Part 11 requirements applicable to the regulated industry. Today, the FDA performs both GxP and Part 11 inspections, with an updated Annex 11 regulation that expands Part 11 requirements, and companies must update their systems and processes to maintain compliance.

You will get a full understanding of how to perform Risk Assessment as part of the step-by-step risk-based approach to computer system validation. This distinct approach will help minimize project time. You can ensure compliance with QA, FDA, and clients.

Majority of inspection reports such as 483’s and Warning Letters quote issues with 21 CFR Part 11 and data integrity as deviations from GxP regulations. Only way to control and avoid warning letters is by receiving effective Training. Mr. Kalpesh Vaghela’s extensive years of experience in the field of third party audit can help your team to better understand & could help reduce your vulnerability of getting 483’s and warning letters, by great amount.

Our instructor will use examples and real life case studies to better illustrate the application of the techniques for any validation project. Using recent warning letters as examples, this seminar will demonstrate how current Part 11 requirements will be met. With effective implementation of learnings from this seminar, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation.

 

Areas Covered in the Seminar:

  • 21 CFR Part 11 Compliance
  • Key Requirements of Part 11
  • Annex 11
  • Learning from Recent Warning Letters
  • Computer System Validation
  • Achieving Data Integrity
  • Meeting Data Integrity Regulations
  • VMP & Design Specifications
  • Risk Assessment
  • Risk Based Validation
  • SOPs and Best Practices
  • CASE STUDIES ….and More

Who Should Attend:

  • Quality Assurance Management and Personnel
  • Regulatory Affairs Management and Personnel
  • Research & Development Management and Personnel
  • Operations Management and Personnel
  • Production Management and Personnel
  • Manufacturing Management and Personnel
  • Engineering Management and Personnel
  • Facility and Maintenance Management and Personnel
  • Everyone involved in Product, Process, CAPA Resolution, Failure Investigation Responsibilities

DAY 1 : (8.30 AM – 6 PM)

Registration: 8.30 AM – 9 AM

1. 21 CFR Part 11:

  • Evolution of 21 CFR Part 11
  • Annex 11
  • Why they are Back in the News
  • Avoid 483’s and Warning Letters
  • Key Requirements of Part 11 & Annex 11 in Detail
  • Electronic signatures, digital pens, and biometric signatures
  • Learning from Recent Warning Letters related to Part 11
  • Detailed experience on validation / 21 CFR 11 compliance of a computer system

2. Data Integrity:

  • Understanding Data Integrity and Security
  • How to Identify and Implement Data Integrity
  • Applying requirements for Data integrity to computerized systems
  • Data integrity Inspections – How FDA & other Regulatory Authorities Inspect
  • Computerized Systems for Data Integrity
  • Meeting domestic and international regulations

Case Studies

Q&A and Networking: 5.30 PM – 6 PM

DAY 2 : (9 AM – 6 PM)

 

1. Risk Assessment:

  • Understanding Risk Assessment
  • How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance
  • Which documents the FDA expects to audit
  • How to use the Risk-Based Validation approach to lower costs
  • How to link requirements, specifications, risk management, and testing
  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation
  • Examples and Good Practices
  • Benefits of larger project

2. Tools, Specifications & Requirements:

  • Validation Master Plan (VMP)
  • Automated Test Tools
  • Infrastructure Requirements
  • Design Specifications
  • Change Control
  • Effective SOPs

Extensive Case Studies

Final Q&A, Certification, Networking & Close: 5.30 PM – 6 PM

Kalpesh Kumar Vaghela
CEO of Infra Control Systems

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.

PRICING OPTIONS & REGISTRATION

 

Fortune Landmark

Ashram road, Usman Pura Circle, Ahmedabad

July 25 – 26, 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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By accessing this website, you agree that Compliance Trainings will not be liable for any loss incurred due to the use of the information and the material contained in this website. The copyright in the material contained in the Website solely belongs to Compliance Trainings and any access to it by the general public does not imply free license to use it unless permitted by law.

 

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.

Cancellation & Refund Policy:

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.

Compliance Trainings reserves the right to change/modify some topics, material, locations or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

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21 CFR Part 11 and Risk Assessment