2018 : 2 Days Conference on UnAnnounced Audits are You Prepared?

By: Dr Arvind K Mishra, Managing Director , Apar Pharma Consulting & Ex- President- Cadila Pharma.
Product code: SEM32
Location 1: Ahmedabad | India Mar 08 - 09

Description

The Indian Pharma industry has been under scrutiny over the last few years and has facedaudits across the year leading to alarming warning letters being received and facing repetitive audits. This has not only impacted reputation of the companies, but it has become imperative for all pharma companies to bring 24/7 quality culture to become all time audit ready.

OVERVIEW

WCS is a US based training and consulting firm with offices in India. WCS has access to top pharmaceutical industry experts and consultants in US and worldwide. Our trainers and consultants will exceed your expectations by providing top quality training that will meet your training objectives.Our consulting services also include pharmaceutical, medical devices, and biotechnology, Regulatory Strategy & Due Diligence,FDA Meeting Preparation & Engagement, FDA Submissions,Audits.

ABOUT THE WORKSHOP

This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing and FDA inspection and external regulatory inspections. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the FDA inspection process from preparing for the inspections, during the inspections and post-inspection responsibilities.

To ensure that companies successfully pass these inspections there is a need to create a culture of compliance throughout the firm that incorporates on - going preparations and frequent inspection readiness practice.

WCS therefore takes pride in announcing the 'Unannounced Audits Workshop' which is taking place in Ahmedabad on 8th - 9th March 2017. The workshop guarantees routine success in FDA inspections which would integrate company culture built on sustaining compliance, significant training and preparation, and flawless execution during the inspections.

Almost each time, mere mention of the term ‘AUDIT’ is enough to raise the level of Norepinephrine HORMONE in our blood and specifically if, Regulatory inspection is from EU or US FDA. The level of such stress is directly proportional to the number of days, we get to breath. Exploding situation is, “when the auditor KNOCKS - UNANNOUNCED at the factory gate.

But why do we require to think about PREPARING. Why can’t we be EVER READY? Where do we fail? The answer is simple but has different dimensions. The session in the coming two days will address the ways, for every time preparedness for any such INSPECTION, by implementing & monitoring very simple practices.

Though the scope of these regulatory inspections have not changed, but their patterns have certainly changed over the years focussing more on Data integrity, Quality Culture, complaint investigation and handling of Out of specification results .The concept now is “Guilty until proven innocent”. The advancements in the software industry have raised the platform to enhance the level of operations w.r.t. Data integrity and ensure enhanced levels of compliance.

We know that FDA has set up its offices in India & other countries to assure that the pharmaceutical organizations work within the frame work of cGMP and in line with what has been committed to the Agency through the Dossier. Facing an uninvited auditor and handling the audit successfully, is inevitable for the organizations eyeing for these markets.

The changed scenario requires a simple & strong strategy. This workshop will focus on the areas of concern, which can keep the activities under control and keep us ever ready for any inspection.

We assure that Post Session, we would have TRANSFORMED, to – We are every time ready.

Areas Covered

•   FDA’s Inspectional Authority and History
•   FDA Inspection Program Overview
•   Key factors for a successful FDA inspection
•   Quality System Readiness
•   Organization Readiness
•   Manage Inspection Outcomes
•   Information and Documentation
•   How a firm should prepare for an FDA inspection?
•   Ways to train employees in view of the inspection
•   How to ensure that required documentation is in place
•   How to interact with the investigator-DO's and DON'T's
•   What companies should do when the inspection ends
•   How to reply to 483's and warning letters
•   All time audit readiness – The need of the hour in the industry
•   Panel Discussion - Quality Culture
•   Data Integrity – The hotbed of observations
•   Inside the mind of the investigator!
•   Quality Metrics (January 2018) Awareness
•   Group Learning Activities:
•   Mock Audits involving Auditor & Investigator and Training the Shop Floor

Who will Benefit

•   General Managers, Senior Managers
•   Executive Management
•   Regulatory Affairs Management
•   Regulatory Affairs Specialist
•   Compliance Officer, Compliance Specialist
•   Clinical Affairs, Auditors
•   Quality Assurance Management
•   Distributors/Authorized Representatives
•   Quality Assurance, Quality Control, Corporate Quality.
•   Engineering/Technical Services
•   Operations/Manufacturing
•   Consultants
•   Legal Counsel
•   Marketing & Sales

Learning Objectives

•   Quality Culture and its impact on audit readiness
•   Anytime Readiness(ATR) and its implication
•   Understanding auditor’s expectation during Unannounced Audits
•   Training of shop floor executives to face audits with confidence
•   Trends in the current inspection practices by FDA and other global regulatory bodies

Benefit of our Training at your site:

•   Will be customized as per your needs
•   Convenience and flexibility
•   Cost-effective
•   Relevant and Personalized
•   Facilitated by experts
•   Flexibility of training platform
•   Certificate

Course Outline:

Day 1 Schedule

•   Inspectional Authority and History
•   FDA Inspection Program Overview
•   Key factors for a successful FDA inspection
•   Quality System Readiness
•   Organization Readiness
•   Manage Inspection Outcomes
•   Information and Documentation
•   How a firm should prepare for an FDA inspection?
•   Ways to train employees in view of the inspection
•   How to ensure that required documentation is in place

 

Day 2 Schedule

•   How to interact with the investigator-DO's and DON'T's
•   What companies should do when the inspection ends
•   How to reply to 483's and warning letters
•   All time audit readiness – The need of the hour in the industry
•   Panel Discussion - Quality Culture
•   Data Integrity – The hotbed of observations
•   Inside the mind of the investigator!
•   Quality Metrics (January 2018) Awareness
•   Group Learning Activities:
•   Mock Audits involving Auditor & Investigator and Training the Shop Floor

 

speaker

Dr Arvind K MishraManaging Director , Apar Pharma Consulting & Ex- President- Cadila Pharma

Dr Arvind K Mishra Having more than 30 years of Pharma industry experience in the field of Quality Control, Global Quality Assurance , Formulation Development & Analytical Development , International Regulatory Affairs and even total plant operation ( mainly formulations including biological ). Handled and supervised green field pharma project ( complying to US FDA , EU , TGA , MHRA and other regulatory requirements) from concept to commissioning in India and abroad. Specialties: Global cGMP compliance, International Regulatory affairs, up-gradation of existing plant to US FDA /EU/TGA/MHRA etc compliant.

08-March-2018 To 09-March-2018 Ahmedabad | India
Seminar One Registration
$ 399



Special Group Discount Register for Four attendees
$ 1400

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 5% off

3 to 6 Attendees - 10% off

7 to 10 Attendees - 15% off

10+ Attendees - 20% 0ff

Other Modes of Payment

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Location: Novotel Ahmedabad

Contact Us:
Ph. 080-48520271 / 99451 31006
Email.support@worldcomplianceseminars.in

How to Reach

Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

Media Partners

Top Media Partners and Sponsors World Compliance Seminars WCS


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Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou. 


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Get 10% discount to media partner's subscribers.

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MEDIA PARTNERS WORK TO DO

Publish Banner on the Media Partner website.

Insertion of the WCS event in the event calendar, both printed and/or online.

Announcement article of the conference on the Magazine and/or Website.

Dedicated email blast to all subscribers

Sponsors

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If you wish to sponsor our event

Please contact us: 

partner@worldcomplianceseminars.com or speak with one of the account manager + 844 267-7299


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$2,000 - Silver Sponsor Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

1 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees


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$4,000 - Silver Gold Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

2 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees

15-20 minutes product demo during the live session

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