Application Of Quality Metrics In Determining Overall State Of Quality. & The Health Of Associated PQS FDA s Current Thinking

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1 Course Objectives: How does industry use Metrics? FDA Challenges and equirements and Use of Quality Metrics Complexities of Implementation (Industry Feedback) What does it all mean? Key in isk identification systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description. Enables the detection of potential problems as early as possible to plan corrective and preventive actions Provides indication that controls are losing effectiveness Important in achieving problem resolution and problem prevention Another important concept of modern quality systems is the use of trending to examine processes as a whole. Training Benefits Greater visibility and transparency between industry and regulators Ability to identify drifts earlier to drive audit/ inspection schedules isk based approach to inspections Increasing consistency of quality metrics Easy to Identifying isks Upon Completion Driving wrong behaviors and unintended consequence Establishing excessive or overly complex metrics Comparing data that is not consistently defined or comparison of single data values Using metrics as a quality surrogate Marcep Inc. is training and consulting provider for pharma sector In India. MACEP INC. train s executive s of all sectors and we do actual work so our motive behind training is to help the skills sharpening for the pharma workforce.

Enables the detection of potential problems as early as possible to plan corrective and preventive actions Provides indication that controls are losing effectiveness Important in achieving problem

2 Day- One Two Day Training Modules: Day- Two Introduction to Quality Matrices What is Quality metrics Background & Glossary Modernization of egulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements Use of Quality Metrics by FDA for isk-based Inspection Scheduling and Prediction of Drug Shortages Legal authority ecords Associated wie Process Validation Lifecycle and PQS Assessment Authority to Inspect ecords and equest in Advance of or In Lieu of an Inspection The Use of Quality Metrics and Effect of Non- eporting How FDA Intends to Use Quality Metrics Effect of Non-eporting Group Discussion: Implementing Trending of Quality Indices in Your Organization The importance of the right culture and people ole of leadership in trending of Quality Indices Developing an online data base for Quality Indices Analysis, interpretation and reporting of Quality Indices The Process Flow Establishing the ground rules, procedures, forms and mechanism for data collection for Quality indices Determining responsibilities and roles for the implementation of trending of Quality Indices eporting of Quality data and Calculation of Quality Metrics Who eports and Who May Contribute to the eport Quality Metrics that FDA Intends to Calculate What Quality Data Would Be eported How to eport Quality Data to FDA Instructions for Quality Metric Data Submission Worksheet for Data Tables Product Specific Information Mandatory Data Optional Metrics ecognizing and Understanding the Trending of Quality Indices Working Session I: Participants will be divided into groups and given a case study and be asked to perform a trend analysis on a given data. Each group will present the results of its analysis Working Session II: Participants will be divided into groups and given a case study and be asked to perform a trend analysis and propose a Quality metric by using isk Based approach for the specific set of data. The results of the analyses will be shared in the class. Complexities of Implementation Quality Metrics Overcoming the pitfalls Benefits and isks General Discussion and Questions Starting the Quality Indices Management Process eview of Quality Indices and Gap evaluation Preparation of Data bases for Data acquisition Collection of data for completeness and Accuracy

PQS Assessment Authority to Inspect ecords and equest in Advance of or In Lieu of an Inspection The Use of Quality Metrics and Effect of Non- eporting How FDA Intends to Use Quality Metrics Effect of

3 Course Director: Dr. Nishodh Saxena PhD - Chem He is a resourceful professional offering about 30 years of experience in executing Quality, egulatory Affairs, Audits & Compliance for green field projects for Pharma, Biotech plants & laboratory set up, expansion, modernization, installation & amp; commissioning of manufacturing unit. Extensive hands on experience on all Injectable/ Parenteral Dosage Forms (Prefilled syringes/ Vials/ Lyophilized Vials/ Multidose pen), Solid Dosage forms and API & intermediate manufacturing. Directly responsible for cgmp compliance and strengthening of Quality Management systems & procedures across the Organization including &D. This includes Harmonization of systems & procedures, cgmp compliance, Corporate audits, Training, Audit and compliance, design and execution, layout design and detailed engineering, validation of facility, water system, equipment, method, process, cleaning validation, computer and electronic system validation, change control, deviation, OOS, OOT, investigation, CAPA, maintenance and preventive maintenance, stability testing, quality control, batch control and product release, media fill trials, documentation system, product recalls, internal quality audit- self inspection, complaint handling, risk analysis, APQ, EM and water quality monitoring, cold chain and shipper validation, Vendor qualification, implementation of IT systems like SAP, EP, LIMS and electronic documentation, knowledge sharing, designing of system according to various country specific regulatory guidelines, including egulatory updates, support for egulatory audits etc. for Manufacturing sites. Have successfully faced several USFDA, MHA, TGA, WHO-Geneva, ANVISA, audits and other MOH audits. Involved in Projects with respect to Quality assurance and automation in QMS. Extensive experience in developing and managing cross functional and multi- location teams/ activities encompassing outsourced manufacturing, in- process QA, technology transfers and compliance to integrated cgmp/ cglp standards and setting up cost effective quality monitoring systems. Ensuring that teams adhere to robust quality standards & procedures through precision/ calibration and monitoring sessions. An out of the box thinker with exceptional track record that demonstrates self- motivation, creativity, and initiative to achieve corporate goals through interpersonal skills and team spirit. Notable Accomplishments: First- hand experience in negotiating with US FDA, CHMP and MHA. Author of Monographs for Indian and European Pharmacopoeia. Played a key role in installation new Analytical, Process Control and QA laboratories through capacity calculation, design, budgeting, and procurement. International speaker on Quality, egulatory & isk Mgmt. aspects of pharma sector. Having a work experience for Indian Pharma Giants: Jubilant Life Sciences Ltd. OmniActives Health Technologies Ltd. Pune USV Ltd. ZydusCadila Healthcare Ltd, Ahmedabad Intas Pharmaceuticals Ltd., Ahmedabad Dr. eddy's Lab Ltd., B. V. Patel (PED) Center, Ahmedabad Nixcil Pharmaceutical Specialties Limited, Lucknow Ph.D. (Chemistry) from Central Drug esearch Institute, Lucknow

Biotech plants & laboratory set up, expansion, modernization, installation & amp; commissioning of manufacturing unit.

4 Delegate egistration Form: Please register the following delegate/s for (For Additional delegates please photocopy this form) PATICIPATION DETAILS Name: Designation: Location: Organisation Details & Authorization: I / We Hereby Confirm To The Above And Authorize Our Participants To The Programme. Please Send The Invoice To: Company Name: Nominating Authority: Designation: Company Postal Address: Tel No.: Cell No.: * This Booking is Invalid Without Signature Signature Investment fees 01 Delegate - IN: 24,500/- (Base Price) Additional service tax of 15% is applicable Sales Hotline No.: or taniya@marcepinc.com Payment Terms: Payment Is equired Within 5 Working Days From the Date Of Invoice. Account Transfer/Cheque/DD Should Be In Favour Of Marcep Inc. Payable At Par In. NON- ESIDENTIAL POGAME Participation Fees Include: Workshop kit Documentation, efreshment, Luncheon, Certificate Of Participation For group nomination queries reply on: info@marcepinc.com Marcep Inc. Terms and Conditions Payment terms - Upon completion and return of the registration form, full payment is required not later than 5 business days from the date of invoice. Payment must be received prior to the event date. Marcep Inc. reserves the right to refuse admission to the event if payment has not been received. Cancellation, postponement and substitution policy - You may substitute delegates at any time by providing reasonable advance notice to Marcep Inc. In the event that Marcep Inc. postpones an event for any reason and the delegate is unable to attend on the revised date, you will receive full credit of the contract fee paid. On mutual agreement, you may use this credit for another Marcep Inc. event which must occur within one year from the date of postponement. Except as specified above, no credits will be issued for cancellations. There are no refunds given under any circumstances. Marcep Inc. is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/ postponement of an event. Marcep Inc. will not take any liability whatsoever if the event is cancelled, rescheduled or postponed due to act of God, natural calamities or any other emergencies. Please note that while course speakers and topics were confirmed at the time of marketing, for circumstances beyond our control, the organization reserves the right to substitute, alter or cancel the speakers and/or topics Marcep Inc. reserves the right to alter or modify the speakers and/or topics if necessary without any liability to you what so ever. Updates on any substitutions or alterations will be provided as soon as possible. Discounts All 'Early Bird' Discounts require payment at time of registration and before the cut-off date in order to receive any discount. Offered discounts by Marcep Inc. (including team discounts) must also require payment at the time of registration. All discount offers will stand cancelled if payment is not received at the time of registration. Marcep Inc. Campz Landmark Bldg., 103, 1st floor, Next to Tata Motors Showroom, S.V. oad, Jogeshwari- West, Tel: Fax: info@marcepinc.com

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GAMP 5 & 21 CFR Part 11 Compliance With Computer System Validation

GAMP 5 & 21 CFR Part 11 Compliance With Computer System Validation Course Objectives: GAMP 5 & Computer System Validation issues are like Diabetes it is not hard to controlled by better life style. If not controlled it can be source of many diseases when combined with