Malaysian Organisation of Pharmaceutical Industries

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Presenter:

CCoouurrssee DDeessccrriippttiioonn The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design (QbD) is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance.

AAiimmss aanndd OObbjjeeccttiivveess Quality means fitness for intended use. Pharmaceutical quality refers to product free of contamination and reproducibly delivers the therapeutic benefit promised in the label to the consumer. The Quality of the pharmaceutical product can be evaluated by in vivo or in vitro performance tests. Quality by design assures in vitro product performance and In vitro product performance provides assurance of in vivo product performance. “Hence Quality by design relate to Product Performance”. Advantages of QbD: Benefits for Industry:

Better understanding of the process. Less batch failure. More efficient and effective control of change. Return on investment / cost savings.

Additional opportunities: An enhance QbD approach to pharmaceutical development

provides opportunities for more flexible regulatory approaches. Who Should Attend

Analytical Development Research & Development Formulation Development Quality Assurance Regulatory Affairs Quality Control

PPS Introduction Knowledge is the key to gain a cutting-edge foothold, globally. At Prescription Pharma Support (PPS), we recognize the significance of continuous updated knowledge and believe it to be the fundamental impetus behind any Pharma company with a global outlook. PPS offers value through the vision and knowledge of professionals who have commendable experience in the industry. Over the past decade, the industry has recognized PPS as a Pioneer Service Provider for the following categories:

Training Workshops

In-house Training

Pharma Recruitments

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Technical Consultancy

Pharma Knowledge Management

Strategic Solutions

Training Grant is available

under HRDF SBL Scheme

(under NGO category)

For further details please visit www.mopi.org.my

Drug Product & Analytical Method Development : Phase 1 (1 – 3 August 2016)

Objective: First the existing set up of R&D, QA, QC & Manufacturing shall be reviewed with respect to QbD requirements & gap analysis shall be presented. Further we will concentrate on bringing the awareness about ICH Q8 guideline which talks about implementation of QbD in Drug Product Development & about ICH Q11 which talks about implementation QbD in API development. Process Analytical Technology which is must for QbD shall be also discussed at length with practical examples. There will be power point presentations as well as open discussions. Aim:

Understand why QbD came into existence & it’s benefits. Know where you currently stand? Understand QbD role in Drug Product Development & Analytical Method Development Know PAT measures that already exist with you & start making meaningful use of those PAT measures.

COURSE OUTLINE

Day2 Current Regulatory Scenario (Cont.) AM►Current regulatory expectation on QbD implementation for developing & developed world Understand ICH Q8 & ICH Q11 PM ► Contents PM ► Steps described PM ► Role of PAT

Day 1 Introduction AM ►Why QbD? AM ►Historical Background AM ►Advantages to the customer & company Current Regulatory Scenario PM ► Regulatory Observations PM ► End Quality VS Built in Quality

Day 3 FDA’s Guidance on PAT AM ►What is PAT AM ►You have it but probably you don’t know it PM ► Must for QbD

Drug Product & Analytical Method Development : Phase II (5 – 7 September 2016) Objective: Here we will be get into actual implementation details. This will be most practical part. There shall be in depth discussion on what is QTTP, CQA & Risk Assessment. Exhaustive presentation on Risk Management as per ICH Q9 guideline shall be made. Failure Mode Effects Analysis (FMEA) shall be discussed with examples. Investigation tools like Fault Tree Analysis, Failure Mode Effects Analysis (FMEA), and Ishikawa shall be presented with case studies. FMEA shall be discussed relatively more in depth to do effective analysis of risks in a predictive manner, Aim:

Understand QTTP & CQA’s & how to link them. How to arrive at Risk Priority Number Do an effective risk assessment

Day 1 QbD Process Step 1: Setting QTPP (Quality Target Product Profile) AM ►Workshop with case studies (internal & external) software use AM ► Prior Knowledge Management (Literature Survey) PM ► Understand QTPP PM ► Setting QTPP for your product

Day 2 QbD Process Step 2: Setting CQA’s (Critical Quality Attributes) AM► Knowledge base for generic product PM ►Linking material attributes to CQA’s PM ► Linking CPP’s (critical process parameters) to CQA’s

Day 3 QbD Process Step 3: Initial Risk Assessment AM►Risk Management principles as per ICH Q9 AM ►FMEA: A good predictive risk management tool PM ►Risk related to product characterisation & development

Drug Product & Analytical Method Development : Phase III (10 – 12 October 2016) Objective: Here the participants would get into hard-core activities of QbD. Participants shall have an option of selecting their own product and feed the required data into their computer and arrive at design of experiments which could be univariate or multivariate. The values could be actual values that you got during your current normal way of development or could be imaginary values taken just for the sake of illustration. There will be specific presentation to explain what is correction, corrective action, and preventive action & how its effectiveness can be validated & monitored. Aim:

Understand what is univariate & multivariate design Understand the overall design of experiments How to plan effective CAPA & monitor it?

COURSE OUTLINE

Drug Product & Analytical Method Development : Phase IV (8 – 10 November 2016) Objective: This phase shall deal with prerequisites of QbD like Development QA & then its implementation. Current global QbD scenario especially the QbD related queries raised by regulators shall be discussed. Concept of Development QA shall be explained & its role towards implementation of QbD. Being the last phase, it would deal with meaningful analysis of data generated out of DoE and make a good report. How to make regulatory submission of QbD report in the eCTD (electronic common technical document) format shall be demonstrated. Aim:

Learn about the role of development QA How to analyse the data generated by DoE ? How to make the QbD report & how to file it?

Day 1 QbD Process Step 4: Design of Experiments AM ►Univariate & multivariate experiments PM ►Data feeding to the computer PM ►Output Data Analysis

Day 2 QbD Process Step 5: Design Space Determination AM ►Analysis of the output PM ►Arrive at the design space PM ►Changes in the design space

Day 3 QbD Process Step 6: Control Strategy & Life Cycle Management AM ►Definition AM ►Risk based approach AM ►Understand product & process PM ►Continuous Process & Method Verification PM ►Correct & Preventive Actions (CAPA)

Day 1 Development QA AM ►Why DQA? AM ►Role of DQA AM►GLP/GMP requirements for R&D Regulatory Submissions PM ►How to submit QbD information? PM ►What to submit PM ►Extent of submission

Day 2 Drug Product Development AM ►Actual Case Study from start to finish PM ► Practical for companies own project: Start to finish PM ►How to make a report?

Day 3 Case studies for the three dosage forms (Tablets, Semi solid & Injection). AM ►Actual Case Study from start to finish PM ► Practical for companies own project: Start to finish PM ►How to make a report?

Vijay Kshirsagar

Mr. Vijay Kshirsagar is a hard core Quality Assurance, Regulatory & Analytical professional with more than 38 years of rich experience of working for highly reputed Indian & Multinational Pharmaceutical firms. Till end April 2013, he worked for Unichem Laboratories Limited as Executive Vice President responsible for Corporate Quality, Regulatory, Analytical Research & Pkg development based in Mumbai for almost 7 years. He continues to be associated with Unichem as Advisor. Prior to Unichem he worked for Ranbaxy as Director-Quality (Pharma) & also for Sun Pharma, Lupin, IPCA, German Remedies & Tata Pharma. He has successfully represented his company in US and UK courts regarding IP related matters (Para IV filing). Vijay has led from front for successful completion of numerous regulatory inspections by US FDA, MHRA, EDQM, ANVISA, WHO, TGA etc. both for Drug Products & API’s. He has been instrumental in driving the filings of dossiers for various markets like US/EU/Brazil/Australia/SA & ROW including several ANDA’s/MAA’s/DMF’s & CEP applications. He has been a frequent trainer in India & abroad having spoken on wide range of topics related to cGMP/GLP/Regulatory/QbD, Validations etc. He is currently working on the board of Directors of ISPE-India. He is also the President of ‘Society for Pharmaceutical Dissolution Science’ (SPDS). He has been conferred upon with an ‘Outstanding Analyst Award 2012’ by IDMA for his contribution towards pharmaceutical analysis. He is M.Sc. by Research from Mumbai University. Recently he has formed his own Pharma Consultancy called TRAC offering specialized services in the areas like cGMP Training, Regulatory Filings , Auditing & Compliance. His clients include reputed multinational and national firms in India and outside including US.

Trainer Profile

Pradeep Karatgi Pradeep Karatgi is the Co-founder and Director at IDRS Labs Pvt. Ltd., Bangalore, India. IDRS Labs is a specialty pharmaceutical organization, based out of Bengaluru, India, offering contract research and development services in the area of formulation and analytical research primarily for per oral (solid and liquid orals) and parenteral dosage forms for NCEs, complex and conventional generics. Prior to founding IDRS, Pradeep was working at Dr. Reddy’s Laboratories Limited, Hyderabad, India as Associate Director and was responsible for leading multiple teams of scientists for enabling product development. Earlier to working at Dr. Reddy’s Laboratories, Pradeep was employed at Ranbaxy Research Laboratories, Gurgaon, India and Torrent Research Center, Gandhinagar, India. Pradeep is post graduate in pharmaceutics and has about 14+ years of experience in formulation research and development, process characterization, scale-up and technology transfer. His experience ranges from developing oral and injectable formulations for NCEs, NDAs and ANDAs. His key achievement has been successful development of two major NDA products. Pradeep has also led the product development and filing of multiple ANDAs with USFDA using QbD / DoE principles. Pradeep has worked with major global pharmaceutical organizations (some of them in top 5) as his clients during his professional career. Specifically on QbD experience, Pradeep has been involved in development of small molecules using principles of Quality-by-Design (QbD) and Design-of-Experiments across formulation and API industries and various dosage forms (solid orals, sterile dosage forms – injectables, ophthalmic and topicals). QbD/DoE services span from ad-hoc project projects to implementation of QbD across the entire organization. Clients are based out of US, Europe and India. 1. Was responsible for establishing QbD platform from scratch across a subdomain of an R&D in a leading Indian pharmaceutical company 2. Acted as internal consultant for trouble-shooting QbD/DoE-related issues 3. Underwent an elaborate “Train the Trainer” curriculum for about 2 years as apart of selected “core team” in a leading Indian Pharmaceutical Organization 4. QbD experience includes: a. 2 implementation of systems and processes for QbD for an entire R&D(API and Formulation) b. 2 NDAs, 6 ANDAs and, 4 DMFs c. 25 formula optimization DoEs, 20 process characterization DoEs d. 2 international publications, 25 reports (PDR/3.2.P.2 etc.) 5. Invited speaker as QbD expert at national industry conferences Pradeep has several patent applications, peer reviewed publications and presentations. He has also authored a book chapter. Pradeep is a panel member of the advisory team at LASSIB CxO confluence and is a co-author for Industry Advisory Report on Knowledge Management that is released across various industrial sectors. One of his international publications – in the journal AAPS Pharmaceutical Science and Technology - is credited as being one of the top five highly downloaded articles and is appreciated by the publishers as well. Pradeep has been an invited speaker at various conferences of national and international repute. Pradeep has been recognized with various awards on multiple occasions for excellent contribution towards innovative research, project execution and delivery during his professional life.

METHODOLOGY: Lectures, workshops, case studies and group activities.

ASSESSMENT: A variety of assessment strategies will be used and may include assignments, classroom engagement, projects and presentations. Participants will be informed of the assessment method, date of assessment and percentage contribution at the start of the module.

Registration Fee per participant per module: (The fee includes course materials, lunch and refreshments)

MOPI Member 30 days before commencement of course RM2,950.00 29 – 14 days before commencement of course RM3,150.00 13 – 7 days before commencement of course RM3,350,00

Non-MOPI Member 30 days before commencement of course RM3,250.00 29 – 14 days before commencement of course RM3,450.00 13 – 7 days before commencement of course RM3,650.00

Foreign Participant 30 days before commencement of course USD $1,300.00 29 – 14 days before commencement of course USD $1,500.00 13 – 7 days before commencement of course USD $1,700.00

Training Venue:

THE BOULEVARD St Giles Premier Hotel

Hotel Address | Mid Valley

City|Lingkaran Syed Putra| 59200 | Kuala Lumpur| Malaysia

Tel: +60.3.22958000 Website: www.StGiles-Hotels.com

BOOK YOUR SEAT NOW!!!

For further enquiries, please contact: Mike/Janet, MOPI

GLOBAL BUSINESS & CONVENTION CENTRE, MEZZANINE FLOOR, BLOCK A, NO. 8, JALAN 19/1, SECTION 19,

46300 PETALING JAYA, SELANGOER, WEST MALAYSIA Tel: 03-7931 9003 Fax: 03-7932 2730

E-mail: mike@mopi.org.my and admin@mopi.org.my www.mopi.org.my

TIME SCHEDULE: 9.00 am – 5.00 pm

8.30am Registration 9.00am AM Topic 10.15am Tea Break 10.30am AM Topic 12.15pm Lunch 1.25pm PM Topic 3.00pm Tea Break 3.15pm PM Topic 5.00pm End

Optional Hotel accommodations: Cititel Mid Valley Tel: 603-2296 1188 Website: www.cititelmidvalley.com Eastin Hotel, PetalingJaya Tel: 603-7665 1111 Website: www.eastin.com Crystal Crown Hotel, PetalingJaya Tel : 603-7958 4422 Website: www.crystalcrown.com.my Armada PJ Hotel Tel: 603-7954 6888 Website: www.armada.com.my

Registration fee is subjected to 6% GST

Training Venue:

Pullman Kuala Lumpur Bangsar

Hotel Address | No. 1, JalanPantai Jaya |Tower 3 | 59200 | Kuala Lumpur|

Malaysia Tel: +60.3.22981888

Website: www.pullmanhotels.com/gb/hotel-7962-

pullman-kuala-lumpur-bangsar-/index.shtml

ADMINISTRATION DETAILS:

Registration will be treated as confirmed only upon receipt of payment in full. CANCELLATIONS & TRANSFERS: If a registrant is unable to attend, a substitute candidate is welcome at no extra charge. Please provide the name and the title of the substitute participant at least 2 working days

prior to the relevant course. Notice of cancellation by fax/email is required 14 working days prior to commencement of each module and refund less RM500 as administration charge will be made. However

a complete set of documentation will be sent to you. Regrettably, no refund can be made for cancellations received less than 10 working days prior to the commencement of each module. However a complete set of documentation

will be sent to you. MOPI / PPS reserves the right to cancel or reschedule the training modules. All efforts will be taken to inform participants of any change. MOPI / PPS however will not be held

liable for reimbursement of any claims or expenses should cancellation or rescheduling occur.

REGISTRATION FORM Subject to Administration details

Please register the following participant(s) for the above program. (To be completed in BLOCK LETTERS)

Enclosed cheque/bank draft No_______________for RM____________ being payment for _______ participant(s) made in favour of the

“Malaysian Organisation of Pharmaceutical Industries”.

Select a course accordingly:

Drug Product & Analytical Method Development : Phase I 1 – 3 August 2016(Mon – Wed) @ Pullman Kuala Lumpur Bangsar

Drug Product & Analytical Method Development : Phase II 5 – 6 September 2016 (Mon – Wed) @ The Boulevard St Giles Premier Hotel

Drug Product & Analytical Method Development :Phase III 10 – 12 October 2016 (Mon – Wed)@ The Boulevard St Giles Premier Hotel

Drug Product & Analytical Method Development :Phase IV 8 – 10 November 2016 (Tue - Thu) @ The Boulevard St Giles Premier Hotel

* * Dates and Instructors are subject to change depending on attendance feedbacks and instructor availability. In case of a change, updated dates and instructor profile will be advised to the organizer and the attendees prior to the start of each course.

Registration Submitted by: Name _____________________________________________________ Designation ________________________________________________ E-mail ____________________________________________________ Company Stamp (with Address, Telephone & Fax Number)

Important Notice: Payment is required with registration and must be received 2 weeks prior to the start of the relevant module to guarantee your place. Walk-in participants will only be admitted on the basis of space availability at the course and with immediate full payment by banker’s cheque in favour of the “Malaysian Organisation of Pharmaceutical Industries”.

Office Use Only

Registration Accepted on …………………. Payment Accepted on ………………….….

2 Name____________________________________________________ Designation_______________________________________________ Email address _____________________________________________

1 Name____________________________________________________ Designation_______________________________________________ Email address _____________________________________________

MOPI Member Non-Member Foreign

Vegetarian Vegetarian

Registration Fee per participant per course: (The fee includes course materials, lunch and refreshments)

MOPI Member 30 days before commencement of course RM2,950.00 29 – 14 days before commencement of course RM3,150.00 13 – 7 days before commencement of course RM3,350,00 Non-MOPI Member 30 days before commencement of course RM3,250.00 29 – 14 days before commencement of course RM3,450.00 13 – 7 days before commencement of course RM3,650.00 Foreign Participant 30 days before commencement of course USD $1,300.00 29 – 14 days before commencement of course USD $1,500.00

Registration fee is subjected to 6% GST

4 Name____________________________________________________ Designation_______________________________________________ Email address _____________________________________________

3 Name____________________________________________________ Designation_______________________________________________ Email address _____________________________________________ Vegetarian Vegetarian