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Data Integrity for Microbiology Labs – Under Microscope of Regulators

12 – 13 December, 2019

Ahmedabad, GJ, India

Data Integrity and Microbiology Lab – Under Microscope of Regulators is a Two days interactive session for exploring and understanding where and why goes wrong in Microbiology Lab which come under Microscopic examination of Regulators.

Data integrity is an important subject and a regulatory ‘hot topic’. This subject matter can directly inform an auditor or inspector about the organization, for data integrity issues occur and are identified by auditors as a direct result of poor quality culture within the organization. Microbiology has been relatively overlooked in relation to this subject, in terms of industry guidance. However, inspection trends indicate that regulators are increasingly focusing on microbiology laboratories and the reliability of data. This webinar provides some best practice guidance.

Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data integrity is a key regulatory concern and guidance documents have been produced by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Moreover, data integrity in relation to the microbiology laboratory features in several FDA warning letters, especially in relation to sample handling and reading.

Despite the current high profile, the subject of data integrity in the pharmaceutical microbiology laboratory has not been afforded very much attention in terms of regulatory guidance or in terms of active discussion through articles penned by those working in the pharmaceutical sectors.

To bridge this gap, this workshop gives you a thorough understanding of the data integrity concerns within the microbiology laboratory and considers all the important steps that can be taken to address identified weaknesses and how to overcome them.

 

Who Should Attend:

  • Quality Control Departments
  • Quality Assurance Departments
  • Microbiologists
  • Information Technology Departments
  • Regulatory Affairs Departments
  • Data integrity Specialists
  • Laboratory Professionals
  • Research and Development Departments
  • Contract Laboratories
  • Validation Departments
  • Compliance Departments
  • Contamination Control Professionals
  • Monitoring Professionals
  • Product Testing Professionals

DAY 1 : (8:30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

Morning Session:

  • Why has Data Integrity in microbiology become a Hot Topic?
  • Current regulatory expectations (FDA/EU/MHRA) and review of recent inspection findings
  • Data Integrity requirements for microbiological equipment
  • Autoclave cycles
  • DHS cycles
  • Media preparation and reconciliation
  • Plate count
  • Detecting Lack of Data Integrity
  • Data Integrity Directed Towards Microbiological Testing

Afternoon Session:

  • Applying data integrity for microbiological tests, from plate reading to microbiological identification
  • Risk-Based Approach to DI in Testing Sites
  • Running a compliant laboratory
  • What data to be generate as microbiologists, within and outside the laboratory
  • Case Study with example of current 483s
  • Cause of 483s
  • Take away

Q&A and Networking: 4.30 PM – 5 PM

DAY 2 : (9 AM – 4:30 PM)

 

Morning Session:

  • Dealing with computerized systems and data
  • Password policy
  • 21 CFR 211 compliance
  • Variability of microbiological data
  • How microbiological data can be correctly and incorrectly interpreted
  • Plate counts
  • Sterility Test
  • BET test
  • Integrating Human Factors into Data Integrity How should data be controlled and reviewed
  • Good practices in handling metadata

Afternoon Session:

  • GMP Data Integrity Requirements
  • Inadequacies of documents in dealing with DI Issues in Microbiology
  • Application of ALCOA Principles to Microbiological DI Issues
  • Alternative Microbial Test Methods
  • How to pass a regulatory inspection for DI
  • Case study – Data Integrity Risk Assessment

Q&A, Certification, Networking and Close: 4.00 PM – 4.30 PM

PRICING OPTIONS & REGISTRATION

Fortune Landmark

Ahmedabad, GJ, India

12 – 13 December, 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.

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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Data Integrity for Microbiology Labs