PhAMA Calendar
Analytical Method Validation and Process Validation Seminar
Venue: Eastin Hotel Petaling Jaya, Grand Ballroom, LG Level
No. 13, Pusat Dagang Phileo Damansara, Jln 16/11, Seksyen 16 46350 Petaling Jaya, Selangor
You are invited to attend the Analytical Method Validation and Process Validation Seminar. This seminar is jointly organised by the Pharmaceutical Association of Malaysia (PhAMA), Malaysian Organisation of Pharmaceutical Industries (MOPI) and Malaysian Association of Pharmaceutical Suppliers (MAPS) in collaboration with the National Pharmaceutical Control Bureau (NPCB), Ministry of Health Malaysia.
The purpose of this seminar is to enhance theregulatoryknowledge andcompetency of product registration holders in the pharmaceutical industryon Analytical MethodValidation and Process Validation requirements. NPCB experts will provide the latest updates on these requirements. They will also provide in-depth clarification and more specific interpretation of the requirements detailed in the Drug Registration Guidance Document (DRGD). They will share common problems encountered with these sections in registration applications as part of the learning process for the industry. This is intended tohelp address the lack of common understanding on these requirements as well as the industry’s difficulties in preparation of the registration submission and in handling questions received from NPCB reviewers for these sections.
Who should attend:
Product Registration Holders, Registration Applicants, Regulatory Managers/Executives, QA/QC
Registration:
Registration fee is RM450 per participant and on a "first-come, first-served" basis up to a maximum of 250 participants. Kindly submit your registration online via this link or download and fill up the registration form below and fax or email to the secretariat.
Download:
- Brochure - PDF, 146 KB
- Programme - PDF, 144 KB
- Registration Form - DOCX, 22 KB
Programme:
Day 1 - 24th September 2014 (Wednesday)
PROGRAM
| 8:00-9:00 | Registration |
| 9:00-9:15 | Welcome & Opening by Mr Tan Ann Ling, Director of NPCB |
| 9:15-10.15 | Introduction on Analytical Method Validation (AMV) Documents Submission Guidelines and Common Problems by Pn. Suhaili Binti Samad |
SESSION 1: Analytical Method Validation - Chemical
Session Moderator: Ms Jaclyn Lee, PhAMA
| 10.15-11:00 | Brief Introduction on Assay, Dissolution and Related Substance AMV Common Problems 1 by Pn. Ooi Suat Hong |
| 11:00-11:20 | Coffee / Tea |
| 11:20-12:05 | AMV Common Problems 2 - by CikTan Shiau Yi |
| 12:05-12:50 | AMV Common Problems 3 - by CikOoi Wei Yen |
| 12:50-2:20 | Lunch |
| 2:20-3:05 | Q & A (Chemical) All speakers from Chemical section |
SESSION 2: Analytical Method Validation - Microbiological
Session Moderator: Ms Loh Kiaw Moi, MOPI
| 3:05-3:50 | BET & Common Problems by Pn. LatifahBinti Ahmad Zawawi |
| 3:50-4:15 | Coffee / Tea |
| 4:15-5:00 | Q & A-BET & Common Problems |
Day 2 - 25th September 2014 (Thursday)
SESSION 2: Analytical Method Validation –Microbiological (Continue)
Session Moderator: Ms Loh Kiaw Moi, MOPI
| 8:00-9:00 | Registration (Morning Coffee / Tea) |
| 9.00-9:45 | MCT & Common problems by Pn. Tan Chin Ling |
| 9:45-10:10 | Coffee / Tea Break |
| 10:10-10:55 | Sterility & Common Problems by Pn. Tan Chin Ling |
| 10:55-11:30 | Q & A All Speakers from Microbiological section |
SESSION 3: Process Validation
Session Moderator: Ms Chong Siew Mei, MAPS
| 11:30-12:15 | Overview on ASEAN Guideline on PV RequirementsProcess Validation Scheme for Solid Oral Dosage Products (non-sterile products) by Pn. Nasyrah Amalina Binti Sarginan |
| 12:15-1:00 | Process Validation Scheme - For Aseptically Processed Products - For Terminally SterilisedProducts by En. Kok Chuan Fung |
| 1:00-2:30 | Lunch |
| 2:30-3:15 | General Considerations before submitting PV Data - Checklist - Q & A of ASEAN Guideline on Process Validation - Case Study / Common Problems by Cik Lim Jia Ai |
| 3:15-4:00 | Q & A (Process Validation) |
| 4:00-5:00 | Closing Coffee / Tea |
Submit your registration online